Guidelines

The American Gastroenterological Association (AGA) has published a Clinical Practice Update on gastric peroral endoscopic myotomy (G-POEM) for gastroparesis.

Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.

Johns Hopkins Medicine

“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”

The authors listed treatment alternatives, noting how associated clinical data have fallen short.

“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
 

Patient selection

G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.

G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
 

Procedural considerations

The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.

“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”

Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”

While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.

Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
 

Adverse events

“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”

Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
 

Insurance companies called to action

After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.

“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”

The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.

The American Gastroenterological Association (AGA) has published a Clinical Practice Update on gastric peroral endoscopic myotomy (G-POEM) for gastroparesis.

Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.

Johns Hopkins Medicine

“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”

The authors listed treatment alternatives, noting how associated clinical data have fallen short.

“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
 

Patient selection

G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.

G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
 

Procedural considerations

The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.

“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”

Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”

While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.

Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
 

Adverse events

“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”

Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
 

Insurance companies called to action

After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.

“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”

The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.

The American Gastroenterological Association (AGA) has published a Clinical Practice Update on gastric peroral endoscopic myotomy (G-POEM) for gastroparesis.

Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.

Johns Hopkins Medicine

“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”

The authors listed treatment alternatives, noting how associated clinical data have fallen short.

“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
 

Patient selection

G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.

G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
 

Procedural considerations

The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.

“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”

Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”

While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.

Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
 

Adverse events

“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”

Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
 

Insurance companies called to action

After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.

“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”

The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.

Systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD) should be grouped into one disease, Still’s disease, according to new diagnosis and treatment recommendations presented at the annual European Congress of Rheumatology.

The recommendations, made in collaboration with EULAR and the Pediatric Rheumatology European Society, emphasized that the ultimate treatment target for Still’s disease should be drug-free remission in all patients and that macrophage activation syndrome (MAS) should be identified and treated as soon as possible.

The task force focused on MAS because despite effective, innovative therapies, “we continued to see MAS,” said presenter Bruno Fautrel, MD, Pitié-Salpêtrière University Hospital, Paris. “We have to be very concerned about this potential complication.”

Dr. Fautrel copresented the recommendations with Fabrizio De Benedetti, MD, PhD, head of the division of rheumatology, Bambino Gesù Hospital, Rome.
 

Diagnosis

Dr. Fautrel noted that the cutoff age of 16 that differentiates sJIA and AOSD is “arbitrary.” There are some differences in age: The frequency of the disease is higher in young children, but it plateaus in young adults. Children under 18 months old are also far more likely to develop MAS.

To diagnose and treat Still’s disease, the recommendations state that clinicians should consider four criteria:

• A fever spiking at or above 39° C (102.2° F) for at least 7 days.
• A transient rash, preferentially on the trunk, that coincides with fever spikes, rash is typically erythematous but other rashes, like urticaria, can be consistent with the diagnosis.
• Some musculoskeletal involvement is common, involving arthralgia/myalgia.
• High levels of inflammation identified by neutrophilic leukocytosis, increased serum C-reactive protein (CRP), and ferritin.

Dr. Fautrel noted that, while arthritis can be present, it is not necessary to make a diagnosis. In pediatrics, “arthritis is likely to happen after a few weeks of the evolution of the disease,” and waiting for arthritis to develop can lead to diagnostic delay, “which is a problem.”

For individuals with suspected Still’s disease, NSAIDs can be used as a “bridging therapy” before the diagnosis is confirmed.
 

Treatment

The recommendations emphasized that treatment and therapeutic strategy “should be based on shared decision-making between the parents/patients and the treating team,” with the ultimate goal of drug-free remission.

To achieve this goal, the document outlines time-based targets for clinically inactive disease (CID). At 4 weeks, patients should have no fever, reduction of active or swollen joint count by more than 50%, a normal CRP level, and a rating of less than 20 on a visual analog scale of 0-100. At 3 months, patients should maintain clinically inactive disease with a glucocorticoid dose of less than 0.1 or 0.2 mg/kg per day. At 6 months, CID should be maintained without glucocorticoids.

While the authors of the recommendations noted that glucocorticoids are efficacious, their long-term use should be avoided because of safety issues. An interleukin-1 or IL-6 inhibitor should be prioritized and initiated as soon as possible after diagnosis.

Patients should maintain CID between 3 and 6 months before tapering off biologics.

The recommendations are congruent with the 2021 American College of Rheumatology’s guidelines for sJIA, noted Karen Onel, MD, pediatric rheumatologist, Hospital for Special Surgery, New York, and the principle investigator for the ACR guidelines. One main difference is that the EULAR recommendations included time lines for treatment targets, while the ACR’s did not.

“It’s great to have these time lines in there,” she said in an interview, though there are still some unknowns. “We don’t actually know what the tapering frequency should be,” she said, “but these are definitely goals that we need to explore and see how they evolve.”
 

MAS and lung complications

The EULAR recommendations also touched on two concerning complications, particularly in children: MAS and lung disease. According to the document, MAS should be considered in patients with Still’s disease with these symptoms: fever, splenomegaly, elevated serum ferritin, low cell counts, abnormal liver function tests, elevated serum triglycerides, and intravascular activation of coagulation. The MAS 2016 criteria can also be used to facilitate diagnosis.

“MAS treatment must include high-dose glucocorticoids,” the document states. “In addition, treatments including anakinra, ciclosporin, and/or interferon-gamma inhibitors should be considered as a part of initial therapy.”

The recommendations also addressed the risk for lung disease, “which is an emerging issue, particularly in children, that the physician should be very well aware of,” Dr. De Benedetti said. This complication can arise at any time point of the disease, he added.

The document advised actively screening for lung disease by searching for clinical symptoms such as digital clubbing, persistent cough, and shortness of breath. Pulmonary function tests like pulse oximetry and diffusing capacity of the lungs for carbon monoxide may also be used, but these standard lung function tests are very difficult to do in children under 6 years old, Dr. De Benedetti noted. The recommendations advise performing high-resolution CT in “any patients with clinical concerns.”

“We have lowered the threshold for CT scan because of the emerging features of this lung disease that may actually be lethal and therefore require prompt attention,” Dr. De Benedetti noted.

The recommendations for lung disease are “broad,” as there is still much to learn about the risk for lung disease in a small portion of sJIA patients, Dr. Onel said.

“There’s a lot that we are trying to work out about this; exactly how to screen, who to screen, what to do, who to treat, and how to treat really remains unclear,” she said. “We absolutely agree that this is a major, major issue that we need to come to some sort of agreement upon, but we’re just not there yet.”

Dr. De Benedetti, Dr. Fautrel, and Dr. Onel disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD) should be grouped into one disease, Still’s disease, according to new diagnosis and treatment recommendations presented at the annual European Congress of Rheumatology.

The recommendations, made in collaboration with EULAR and the Pediatric Rheumatology European Society, emphasized that the ultimate treatment target for Still’s disease should be drug-free remission in all patients and that macrophage activation syndrome (MAS) should be identified and treated as soon as possible.

The task force focused on MAS because despite effective, innovative therapies, “we continued to see MAS,” said presenter Bruno Fautrel, MD, Pitié-Salpêtrière University Hospital, Paris. “We have to be very concerned about this potential complication.”

Dr. Fautrel copresented the recommendations with Fabrizio De Benedetti, MD, PhD, head of the division of rheumatology, Bambino Gesù Hospital, Rome.
 

Diagnosis

Dr. Fautrel noted that the cutoff age of 16 that differentiates sJIA and AOSD is “arbitrary.” There are some differences in age: The frequency of the disease is higher in young children, but it plateaus in young adults. Children under 18 months old are also far more likely to develop MAS.

To diagnose and treat Still’s disease, the recommendations state that clinicians should consider four criteria:

• A fever spiking at or above 39° C (102.2° F) for at least 7 days.
• A transient rash, preferentially on the trunk, that coincides with fever spikes, rash is typically erythematous but other rashes, like urticaria, can be consistent with the diagnosis.
• Some musculoskeletal involvement is common, involving arthralgia/myalgia.
• High levels of inflammation identified by neutrophilic leukocytosis, increased serum C-reactive protein (CRP), and ferritin.

Dr. Fautrel noted that, while arthritis can be present, it is not necessary to make a diagnosis. In pediatrics, “arthritis is likely to happen after a few weeks of the evolution of the disease,” and waiting for arthritis to develop can lead to diagnostic delay, “which is a problem.”

For individuals with suspected Still’s disease, NSAIDs can be used as a “bridging therapy” before the diagnosis is confirmed.
 

Treatment

The recommendations emphasized that treatment and therapeutic strategy “should be based on shared decision-making between the parents/patients and the treating team,” with the ultimate goal of drug-free remission.

To achieve this goal, the document outlines time-based targets for clinically inactive disease (CID). At 4 weeks, patients should have no fever, reduction of active or swollen joint count by more than 50%, a normal CRP level, and a rating of less than 20 on a visual analog scale of 0-100. At 3 months, patients should maintain clinically inactive disease with a glucocorticoid dose of less than 0.1 or 0.2 mg/kg per day. At 6 months, CID should be maintained without glucocorticoids.

While the authors of the recommendations noted that glucocorticoids are efficacious, their long-term use should be avoided because of safety issues. An interleukin-1 or IL-6 inhibitor should be prioritized and initiated as soon as possible after diagnosis.

Patients should maintain CID between 3 and 6 months before tapering off biologics.

The recommendations are congruent with the 2021 American College of Rheumatology’s guidelines for sJIA, noted Karen Onel, MD, pediatric rheumatologist, Hospital for Special Surgery, New York, and the principle investigator for the ACR guidelines. One main difference is that the EULAR recommendations included time lines for treatment targets, while the ACR’s did not.

“It’s great to have these time lines in there,” she said in an interview, though there are still some unknowns. “We don’t actually know what the tapering frequency should be,” she said, “but these are definitely goals that we need to explore and see how they evolve.”
 

MAS and lung complications

The EULAR recommendations also touched on two concerning complications, particularly in children: MAS and lung disease. According to the document, MAS should be considered in patients with Still’s disease with these symptoms: fever, splenomegaly, elevated serum ferritin, low cell counts, abnormal liver function tests, elevated serum triglycerides, and intravascular activation of coagulation. The MAS 2016 criteria can also be used to facilitate diagnosis.

“MAS treatment must include high-dose glucocorticoids,” the document states. “In addition, treatments including anakinra, ciclosporin, and/or interferon-gamma inhibitors should be considered as a part of initial therapy.”

The recommendations also addressed the risk for lung disease, “which is an emerging issue, particularly in children, that the physician should be very well aware of,” Dr. De Benedetti said. This complication can arise at any time point of the disease, he added.

The document advised actively screening for lung disease by searching for clinical symptoms such as digital clubbing, persistent cough, and shortness of breath. Pulmonary function tests like pulse oximetry and diffusing capacity of the lungs for carbon monoxide may also be used, but these standard lung function tests are very difficult to do in children under 6 years old, Dr. De Benedetti noted. The recommendations advise performing high-resolution CT in “any patients with clinical concerns.”

“We have lowered the threshold for CT scan because of the emerging features of this lung disease that may actually be lethal and therefore require prompt attention,” Dr. De Benedetti noted.

The recommendations for lung disease are “broad,” as there is still much to learn about the risk for lung disease in a small portion of sJIA patients, Dr. Onel said.

“There’s a lot that we are trying to work out about this; exactly how to screen, who to screen, what to do, who to treat, and how to treat really remains unclear,” she said. “We absolutely agree that this is a major, major issue that we need to come to some sort of agreement upon, but we’re just not there yet.”

Dr. De Benedetti, Dr. Fautrel, and Dr. Onel disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD) should be grouped into one disease, Still’s disease, according to new diagnosis and treatment recommendations presented at the annual European Congress of Rheumatology.

The recommendations, made in collaboration with EULAR and the Pediatric Rheumatology European Society, emphasized that the ultimate treatment target for Still’s disease should be drug-free remission in all patients and that macrophage activation syndrome (MAS) should be identified and treated as soon as possible.

The task force focused on MAS because despite effective, innovative therapies, “we continued to see MAS,” said presenter Bruno Fautrel, MD, Pitié-Salpêtrière University Hospital, Paris. “We have to be very concerned about this potential complication.”

Dr. Fautrel copresented the recommendations with Fabrizio De Benedetti, MD, PhD, head of the division of rheumatology, Bambino Gesù Hospital, Rome.
 

Diagnosis

Dr. Fautrel noted that the cutoff age of 16 that differentiates sJIA and AOSD is “arbitrary.” There are some differences in age: The frequency of the disease is higher in young children, but it plateaus in young adults. Children under 18 months old are also far more likely to develop MAS.

To diagnose and treat Still’s disease, the recommendations state that clinicians should consider four criteria:

• A fever spiking at or above 39° C (102.2° F) for at least 7 days.
• A transient rash, preferentially on the trunk, that coincides with fever spikes, rash is typically erythematous but other rashes, like urticaria, can be consistent with the diagnosis.
• Some musculoskeletal involvement is common, involving arthralgia/myalgia.
• High levels of inflammation identified by neutrophilic leukocytosis, increased serum C-reactive protein (CRP), and ferritin.

Dr. Fautrel noted that, while arthritis can be present, it is not necessary to make a diagnosis. In pediatrics, “arthritis is likely to happen after a few weeks of the evolution of the disease,” and waiting for arthritis to develop can lead to diagnostic delay, “which is a problem.”

For individuals with suspected Still’s disease, NSAIDs can be used as a “bridging therapy” before the diagnosis is confirmed.
 

Treatment

The recommendations emphasized that treatment and therapeutic strategy “should be based on shared decision-making between the parents/patients and the treating team,” with the ultimate goal of drug-free remission.

To achieve this goal, the document outlines time-based targets for clinically inactive disease (CID). At 4 weeks, patients should have no fever, reduction of active or swollen joint count by more than 50%, a normal CRP level, and a rating of less than 20 on a visual analog scale of 0-100. At 3 months, patients should maintain clinically inactive disease with a glucocorticoid dose of less than 0.1 or 0.2 mg/kg per day. At 6 months, CID should be maintained without glucocorticoids.

While the authors of the recommendations noted that glucocorticoids are efficacious, their long-term use should be avoided because of safety issues. An interleukin-1 or IL-6 inhibitor should be prioritized and initiated as soon as possible after diagnosis.

Patients should maintain CID between 3 and 6 months before tapering off biologics.

The recommendations are congruent with the 2021 American College of Rheumatology’s guidelines for sJIA, noted Karen Onel, MD, pediatric rheumatologist, Hospital for Special Surgery, New York, and the principle investigator for the ACR guidelines. One main difference is that the EULAR recommendations included time lines for treatment targets, while the ACR’s did not.

“It’s great to have these time lines in there,” she said in an interview, though there are still some unknowns. “We don’t actually know what the tapering frequency should be,” she said, “but these are definitely goals that we need to explore and see how they evolve.”
 

MAS and lung complications

The EULAR recommendations also touched on two concerning complications, particularly in children: MAS and lung disease. According to the document, MAS should be considered in patients with Still’s disease with these symptoms: fever, splenomegaly, elevated serum ferritin, low cell counts, abnormal liver function tests, elevated serum triglycerides, and intravascular activation of coagulation. The MAS 2016 criteria can also be used to facilitate diagnosis.

“MAS treatment must include high-dose glucocorticoids,” the document states. “In addition, treatments including anakinra, ciclosporin, and/or interferon-gamma inhibitors should be considered as a part of initial therapy.”

The recommendations also addressed the risk for lung disease, “which is an emerging issue, particularly in children, that the physician should be very well aware of,” Dr. De Benedetti said. This complication can arise at any time point of the disease, he added.

The document advised actively screening for lung disease by searching for clinical symptoms such as digital clubbing, persistent cough, and shortness of breath. Pulmonary function tests like pulse oximetry and diffusing capacity of the lungs for carbon monoxide may also be used, but these standard lung function tests are very difficult to do in children under 6 years old, Dr. De Benedetti noted. The recommendations advise performing high-resolution CT in “any patients with clinical concerns.”

“We have lowered the threshold for CT scan because of the emerging features of this lung disease that may actually be lethal and therefore require prompt attention,” Dr. De Benedetti noted.

The recommendations for lung disease are “broad,” as there is still much to learn about the risk for lung disease in a small portion of sJIA patients, Dr. Onel said.

“There’s a lot that we are trying to work out about this; exactly how to screen, who to screen, what to do, who to treat, and how to treat really remains unclear,” she said. “We absolutely agree that this is a major, major issue that we need to come to some sort of agreement upon, but we’re just not there yet.”

Dr. De Benedetti, Dr. Fautrel, and Dr. Onel disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A European Alliance of Associations for Rheumatology task force has released new guidance on imaging of crystal-induced arthropathies (CiA). The document provides recommendations for using imaging for diagnosis and monitoring of these types of diseases.

“These are the first-ever EULAR recommendations on imaging in this group of diseases. In fact, we are not aware of any similar international recommendations which provide guidance on which imaging technique, when, and how [they] should be used for crystal-induced arthropathies,” lead author Peter Mandl, MD, PhD, of the division of rheumatology at the Medical University of Vienna, told this news organization. Dr. Mandl presented the new recommendations at the annual European Congress of Rheumatology.

While some rheumatologists very familiar with crystal-induced arthropathies already regularly use imaging with these patients, these formal recommendations could highlight to wider audiences that “these imaging modalities can be very sensitive and specific for CiA,” said Sara K. Tedeschi, MD, MPH, assistant professor of medicine at Harvard Medical School and head of crystal-induced arthritis diseases at Brigham and Women’s Hospital in Boston. She was not involved with the work.

The document included general recommendations for imaging in CiA as well as specific recommendations for gout, basic calcium phosphate deposition disease (BCPD), and calcium pyrophosphate deposition disease (CPPD). Across all disease types, performing imaging on symptomatic areas as well as disease-specific target sites should be considered, the recommendations state. This includes the first metatarsophalangeal joint in gout, the wrist and knee in CPPD, and the shoulder in BCPD.

Both ultrasound (US) and dual-energy CT (DECT) are the recommended imaging modalities in gout. If imaging reveals characteristic features of monosodium urate (MSU) crystal deposition, synovial fluid analysis is not necessary to confirm a gout diagnosis. The volume of MSU crystals on imaging can also be used to predict future disease flares.

Showing imaging and explaining imaging findings may help patients understand their condition and adhere to treatment regimens, the recommendations state. “I think it’s a very powerful way to counsel patients,” Dr. Tedeschi said in an interview.

Imaging is necessary in the diagnosis of BCPD, and clinicians should use either conventional radiography or US. These imagining modalities are recommended for CPPD, and clinicians can use CT if they suspect axial involvement. The document does not recommend serial imaging for either BCPD or CPPD unless there has been an “unsuspected change in clinical characteristics.”

These recommendations highlight how imaging can have a “powerful impact on patient counseling and diagnosis,” said Dr. Tedeschi. She emphasized the importance of US training in rheumatology fellowship programs.

During his presentation at EULAR 2023, Dr. Mandl also highlighted a robust research agenda to further investigate how imaging can aid in the diagnosis and treatment of CiA. “It would be great to have an imaging modality someday that would help us differentiate between various types of calcium crystal,” he said.

Dr. Mandl has financial relationships with AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Roche, and UCB. Dr. Tedeschi has worked as a consultant for Novartis.

A version of this article first appeared on Medscape.com.

A European Alliance of Associations for Rheumatology task force has released new guidance on imaging of crystal-induced arthropathies (CiA). The document provides recommendations for using imaging for diagnosis and monitoring of these types of diseases.

“These are the first-ever EULAR recommendations on imaging in this group of diseases. In fact, we are not aware of any similar international recommendations which provide guidance on which imaging technique, when, and how [they] should be used for crystal-induced arthropathies,” lead author Peter Mandl, MD, PhD, of the division of rheumatology at the Medical University of Vienna, told this news organization. Dr. Mandl presented the new recommendations at the annual European Congress of Rheumatology.

While some rheumatologists very familiar with crystal-induced arthropathies already regularly use imaging with these patients, these formal recommendations could highlight to wider audiences that “these imaging modalities can be very sensitive and specific for CiA,” said Sara K. Tedeschi, MD, MPH, assistant professor of medicine at Harvard Medical School and head of crystal-induced arthritis diseases at Brigham and Women’s Hospital in Boston. She was not involved with the work.

The document included general recommendations for imaging in CiA as well as specific recommendations for gout, basic calcium phosphate deposition disease (BCPD), and calcium pyrophosphate deposition disease (CPPD). Across all disease types, performing imaging on symptomatic areas as well as disease-specific target sites should be considered, the recommendations state. This includes the first metatarsophalangeal joint in gout, the wrist and knee in CPPD, and the shoulder in BCPD.

Both ultrasound (US) and dual-energy CT (DECT) are the recommended imaging modalities in gout. If imaging reveals characteristic features of monosodium urate (MSU) crystal deposition, synovial fluid analysis is not necessary to confirm a gout diagnosis. The volume of MSU crystals on imaging can also be used to predict future disease flares.

Showing imaging and explaining imaging findings may help patients understand their condition and adhere to treatment regimens, the recommendations state. “I think it’s a very powerful way to counsel patients,” Dr. Tedeschi said in an interview.

Imaging is necessary in the diagnosis of BCPD, and clinicians should use either conventional radiography or US. These imagining modalities are recommended for CPPD, and clinicians can use CT if they suspect axial involvement. The document does not recommend serial imaging for either BCPD or CPPD unless there has been an “unsuspected change in clinical characteristics.”

These recommendations highlight how imaging can have a “powerful impact on patient counseling and diagnosis,” said Dr. Tedeschi. She emphasized the importance of US training in rheumatology fellowship programs.

During his presentation at EULAR 2023, Dr. Mandl also highlighted a robust research agenda to further investigate how imaging can aid in the diagnosis and treatment of CiA. “It would be great to have an imaging modality someday that would help us differentiate between various types of calcium crystal,” he said.

Dr. Mandl has financial relationships with AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Roche, and UCB. Dr. Tedeschi has worked as a consultant for Novartis.

A version of this article first appeared on Medscape.com.

A European Alliance of Associations for Rheumatology task force has released new guidance on imaging of crystal-induced arthropathies (CiA). The document provides recommendations for using imaging for diagnosis and monitoring of these types of diseases.

“These are the first-ever EULAR recommendations on imaging in this group of diseases. In fact, we are not aware of any similar international recommendations which provide guidance on which imaging technique, when, and how [they] should be used for crystal-induced arthropathies,” lead author Peter Mandl, MD, PhD, of the division of rheumatology at the Medical University of Vienna, told this news organization. Dr. Mandl presented the new recommendations at the annual European Congress of Rheumatology.

While some rheumatologists very familiar with crystal-induced arthropathies already regularly use imaging with these patients, these formal recommendations could highlight to wider audiences that “these imaging modalities can be very sensitive and specific for CiA,” said Sara K. Tedeschi, MD, MPH, assistant professor of medicine at Harvard Medical School and head of crystal-induced arthritis diseases at Brigham and Women’s Hospital in Boston. She was not involved with the work.

The document included general recommendations for imaging in CiA as well as specific recommendations for gout, basic calcium phosphate deposition disease (BCPD), and calcium pyrophosphate deposition disease (CPPD). Across all disease types, performing imaging on symptomatic areas as well as disease-specific target sites should be considered, the recommendations state. This includes the first metatarsophalangeal joint in gout, the wrist and knee in CPPD, and the shoulder in BCPD.

Both ultrasound (US) and dual-energy CT (DECT) are the recommended imaging modalities in gout. If imaging reveals characteristic features of monosodium urate (MSU) crystal deposition, synovial fluid analysis is not necessary to confirm a gout diagnosis. The volume of MSU crystals on imaging can also be used to predict future disease flares.

Showing imaging and explaining imaging findings may help patients understand their condition and adhere to treatment regimens, the recommendations state. “I think it’s a very powerful way to counsel patients,” Dr. Tedeschi said in an interview.

Imaging is necessary in the diagnosis of BCPD, and clinicians should use either conventional radiography or US. These imagining modalities are recommended for CPPD, and clinicians can use CT if they suspect axial involvement. The document does not recommend serial imaging for either BCPD or CPPD unless there has been an “unsuspected change in clinical characteristics.”

These recommendations highlight how imaging can have a “powerful impact on patient counseling and diagnosis,” said Dr. Tedeschi. She emphasized the importance of US training in rheumatology fellowship programs.

During his presentation at EULAR 2023, Dr. Mandl also highlighted a robust research agenda to further investigate how imaging can aid in the diagnosis and treatment of CiA. “It would be great to have an imaging modality someday that would help us differentiate between various types of calcium crystal,” he said.

Dr. Mandl has financial relationships with AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Roche, and UCB. Dr. Tedeschi has worked as a consultant for Novartis.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force (USPSTF) has posted final recommendations on screening for anxiety, depression, and suicide risk in adults.

In line with draft recommendations, the task force for the first time has endorsed screening for anxiety disorders in all adults younger than age 65 without recognized signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit. There currently is not enough evidence to recommend for or against screening for anxiety disorders in adults 65 and older, the task force said.

The USPSTF final recommendation statements and corresponding evidence summaries were published online in the Journal of the American Medical Association, as well as on the task force website.
 

Jury out on screening for suicide risk

The task force continues to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.

However, there is not enough evidence to recommend for or against screening for suicide risk in all adults. Therefore, the task issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.

“We are urgently calling for more research to determine the effectiveness of screening all adults for suicide risk and screening adults 65 and older for anxiety disorders,” task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health, New York, said in a statement.

The authors of an accompanying editorial noted that a positive screen result for anxiety “should be immediately followed with clinical evaluation for suicidality”.

Murray Stein, MD, MPH, and Linda Hill, MD, MPH, both with University of California, San Diego, also noted that a positive screen for anxiety could be indicative of posttraumatic stress disorder (PTSD) and clinicians should “be prepared to follow up with requisite questions about traumatic experiences that will be needed to home in on a diagnosis of PTSD that may require additional follow-up, referral, or both.

“Anxiety disorders can be distressing and disabling, and appropriate recognition and treatment can be life-altering and, in some cases, lifesaving, for patients,” Dr. Stein and Dr. Hill pointed out.

Effective, evidence-based psychological and pharmacologic treatments for anxiety disorders are available, they added. But the recommendation to routinely screen for anxiety disorder “must be accompanied by the recognition that there are too few mental health specialists available to manage the care of all patients with anxiety disorders, and even fewer who provide services for low-income and non-English-speaking populations,” they wrote.

This research report received no commercial funding. Disclosures for task force members and editorial writers are listed with the original articles.
 

A version of this article originally appeared on Medscape.com.

The U.S. Preventive Services Task Force (USPSTF) has posted final recommendations on screening for anxiety, depression, and suicide risk in adults.

In line with draft recommendations, the task force for the first time has endorsed screening for anxiety disorders in all adults younger than age 65 without recognized signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit. There currently is not enough evidence to recommend for or against screening for anxiety disorders in adults 65 and older, the task force said.

The USPSTF final recommendation statements and corresponding evidence summaries were published online in the Journal of the American Medical Association, as well as on the task force website.
 

Jury out on screening for suicide risk

The task force continues to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.

However, there is not enough evidence to recommend for or against screening for suicide risk in all adults. Therefore, the task issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.

“We are urgently calling for more research to determine the effectiveness of screening all adults for suicide risk and screening adults 65 and older for anxiety disorders,” task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health, New York, said in a statement.

The authors of an accompanying editorial noted that a positive screen result for anxiety “should be immediately followed with clinical evaluation for suicidality”.

Murray Stein, MD, MPH, and Linda Hill, MD, MPH, both with University of California, San Diego, also noted that a positive screen for anxiety could be indicative of posttraumatic stress disorder (PTSD) and clinicians should “be prepared to follow up with requisite questions about traumatic experiences that will be needed to home in on a diagnosis of PTSD that may require additional follow-up, referral, or both.

“Anxiety disorders can be distressing and disabling, and appropriate recognition and treatment can be life-altering and, in some cases, lifesaving, for patients,” Dr. Stein and Dr. Hill pointed out.

Effective, evidence-based psychological and pharmacologic treatments for anxiety disorders are available, they added. But the recommendation to routinely screen for anxiety disorder “must be accompanied by the recognition that there are too few mental health specialists available to manage the care of all patients with anxiety disorders, and even fewer who provide services for low-income and non-English-speaking populations,” they wrote.

This research report received no commercial funding. Disclosures for task force members and editorial writers are listed with the original articles.
 

A version of this article originally appeared on Medscape.com.

The U.S. Preventive Services Task Force (USPSTF) has posted final recommendations on screening for anxiety, depression, and suicide risk in adults.

In line with draft recommendations, the task force for the first time has endorsed screening for anxiety disorders in all adults younger than age 65 without recognized signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in this population has a moderate net benefit. There currently is not enough evidence to recommend for or against screening for anxiety disorders in adults 65 and older, the task force said.

The USPSTF final recommendation statements and corresponding evidence summaries were published online in the Journal of the American Medical Association, as well as on the task force website.
 

Jury out on screening for suicide risk

The task force continues to recommend screening all adults for depression. This “B” recommendation reflects moderate-certainty evidence that screening for major depression in adults has a moderate net benefit.

However, there is not enough evidence to recommend for or against screening for suicide risk in all adults. Therefore, the task issued an “I” statement, indicating that the balance of benefits and harms cannot be determined at present.

“We are urgently calling for more research to determine the effectiveness of screening all adults for suicide risk and screening adults 65 and older for anxiety disorders,” task force member Gbenga Ogedegbe, MD, MPH, founding director of the Institute for Excellence in Health Equity at NYU Langone Health, New York, said in a statement.

The authors of an accompanying editorial noted that a positive screen result for anxiety “should be immediately followed with clinical evaluation for suicidality”.

Murray Stein, MD, MPH, and Linda Hill, MD, MPH, both with University of California, San Diego, also noted that a positive screen for anxiety could be indicative of posttraumatic stress disorder (PTSD) and clinicians should “be prepared to follow up with requisite questions about traumatic experiences that will be needed to home in on a diagnosis of PTSD that may require additional follow-up, referral, or both.

“Anxiety disorders can be distressing and disabling, and appropriate recognition and treatment can be life-altering and, in some cases, lifesaving, for patients,” Dr. Stein and Dr. Hill pointed out.

Effective, evidence-based psychological and pharmacologic treatments for anxiety disorders are available, they added. But the recommendation to routinely screen for anxiety disorder “must be accompanied by the recognition that there are too few mental health specialists available to manage the care of all patients with anxiety disorders, and even fewer who provide services for low-income and non-English-speaking populations,” they wrote.

This research report received no commercial funding. Disclosures for task force members and editorial writers are listed with the original articles.
 

A version of this article originally appeared on Medscape.com.

MILAN – Treatment of systemic lupus erythematosus with biologics may enable steroid tapering while ensuring the achievement of remission or low disease activity in more patients with fewer flares and less organ damage, as well as leading to better responses if used early, according to the latest recommendations on the management of SLE from the European Alliance of Associations for Rheumatology (EULAR).

Dimitrios Boumpas, MD, president of the Athens Medical Society and chair of the European Task force on SLE, presented the recommendations at the annual European Congress of Rheumatology. “Although steroids save lives, it is at the expense of excessive collateral damage. They are better for short-term use as a rescue or bridging therapy but may be used in some patients at 5 mg/day of prednisone or less, rather than the previous 7.5 mg/day,” he emphasized.

The 2023 recommendations cover new treatment strategies with more ambitious goals, new data on adverse effects of chronic glucocorticoid use, and newly approved agents and combination therapies.

“Most importantly, we sourced help from experts from all over the world,” said Dr. Boumpas, describing the task force that included 35 rheumatologists, 5 nephrologists, 2 methodologists, 2 patient representatives, and 2 fellows, all brought together from across Europe, North America, Asia, and Australia.

Over 7,000 papers were reviewed, with 437 included in the systematic literature review to inform the updated recommendations.

Session moderator Robert Landewé, MD, PhD, professor of clinical immunology and rheumatology at the University of Amsterdam, said that “the underlying heterogeneity and multisystem involvement of SLE can make it difficult to demonstrate and know which drugs work in the condition. However, these latest recommendations should encourage greater confidence to taper steroids early on and perhaps consider new biologic drugs, so that more patients can achieve better results sooner to prevent flares and organ damage, improve prognosis, and enhance their quality of life.”

Dr. Boumpas provided a summary of the overarching principles that guide the recommendations. These say that SLE requires multidisciplinary individualized management; disease activity should be assessed at each visit; nonpharmacologic interventions such as sun protection, smoking cessation, and following a healthy diet are all important for improving long-term outcomes; pharmacologic interventions are to be directed by patient characteristics, type and severity of organ involvement, treatment-related harms, and patient preferences, among other factors; and early SLE diagnosis is essential to prevent flares and organ damage, improve prognosis, and enhance quality of life.

Referring to each recommendation statement in turn, Dr. Boumpas provided a detailed description of each, and highlighted any changes since the 2019 recommendations.
 

Hydroxychloroquine, glucocorticoids as bridging therapy, and biologics

Referring to statement 1, Dr. Boumpas reported that hydroxychloroquine should be a first-line therapy at a dose of 5 mg/kg, but this dose should be individualized based on risk of flare and retinal toxicity. “There was some discussion about monitoring blood levels, but this was to ensure adherence only,” said Dr. Boumpas.

Continuing to statement 2, he added, “here is one change. With chronic use of glucocorticoids, the maintenance dose is 5 mg/day or less or prednisone equivalent. This pertains to both new onset and relapsing disease.” Previous recommendations advised a maintenance dose of 7.5 mg/day or less.

But he pointed out that “we are discussing using glucocorticoids in lupus as a bridging therapy only, for short, limited periods of time. We should shy away from chronic use of glucocorticoids and only use them for 3 months, and to do this we need to use glucocorticoid-sparing strategies.”

This led to statement 3, which refers to glucocorticoid-sparing strategies. Dr. Boumpas explained that, in patients who are not responding to hydroxychloroquine or unable to reduce glucocorticoids further during chronic use, add immunosuppressive agents, such as methotrexate and/or biologics (for example, belimumab [Benlysta] or anifrolumab [Saphnelo]).

“To allow flexibility for patients and clinicians, it isn’t necessary to use DMARDs [disease-modifying antirheumatic drugs] first if you prefer biologics,” he continued. “We are becoming more liberal with the use of biologics because there are new data that confirm the efficacy of belimumab in extrarenal SLE, plus good data with 3-year extension with anifrolumab.”

Statement 4 says that for patients with organ- or life-threatening disease, intravenous cyclophosphamide, “our old friend,” should be considered, while in refractory cases, rituximab may be considered, Dr. Boumpas said. “It’s okay to use cyclophosphamide. It isn’t a sin.”

Statement 5 refers to skin disease, and Dr. Boumpas explained that good data suggested that biologics help, including both belimumab and anifrolumab.

Nothing has changed with statement 6 concerning neuropsychiatric lupus, said Dr. Boumpas. “Glucocorticoids, immunosuppressive, and antithrombotic therapies should be considered.”

Regarding hematologic disease (statement 7), he said, “the new kid on the block is MMF [mycophenolate mofetil]. For acute treatment, still use the same drugs, including rituximab, but for maintenance you may use rituximab, azathioprine, MMF, or cyclosporine.”
 

Lupus nephritis

Turning to what Dr. Boumpas described as the “reason you had all come here, and what you had been waiting for ... what’s changing with lupus nephritis?” he said.

Statement 8 describes initial therapy in active lupus nephritis. Dr. Boumpas said that low-dose, intravenous cyclophosphamide or mycophenolate should be considered, but also that belimumab or a calcineurin inhibitor (CNI) should be considered at the start. The changes were based on two successful phase 3 trials of belimumab and voclosporin, with belimumab being associated with a reduced flare rate and estimated glomerular filtration rate (eGFR).

“Changes from 2019 include that there is no distinction between classes III/IV and V, which is heretical,” he stressed. Belimumab and CNIs/voclosporin should be considered in all patents as an add-on therapy from the start. “Lupus nephritis has high morbidity, and it’s difficult to predict outcomes at the beginning, but there are clear benefits of add-on therapies. CNIs, although they can be used for all patients, might be more appropriate for membranous or nephrotic-range proteinuria.”

He went on to announce that the “million-dollar question” was whether to use belimumab or voclosporin (or other CNIs), and that this was “a question of gentle, compared with forceful, power and collateral damage.

“For me, voclosporin works very fast, but you worry about side effects, while belimumab is gentle and the response is sustained, preventing flares and organ damage,” he said, adding that “our expert panel discussions showed that nephrologists were more eager to support steroid-free regimens.”

Moving on to statement 9, Dr. Boumpas explained that after initial therapy and renal response, subsequent therapy should continue for at least 3 years. If treated with MMF alone or in combination with belimumab, then these drugs should continue. However, MMF should replace cyclophosphamide if the latter is used initially.

Regarding treat-to-target in lupus nephritis, he said that EULAR now advises to aim for a 25% drop in urine protein/creatinine ratio by 3 months, a 50% drop by 6 months, and a UPCR of less than 0.5-0.7, plus normal eGFR, by 12 months, Dr. Boumpas said.

Statement 10 advises considering high-dose intravenous cyclophosphamide in combination with pulse intravenous methylprednisolone for patients at high risk of renal failure.
 

Tapering drugs in sustained remission, managing antiphospholipid syndrome, giving immunizations

Statement 11 suggests to consider tapering immunosuppressive agents and glucocorticoids in patients achieving sustained remission, starting with glucocorticoids first.

There was no change to statement 12, which recommends that thrombotic antiphospholipid syndrome associated with SLE be treated with long-term vitamin K antagonists.

Statement 13 addresses immunizations and adjunct therapies. In addition to conventional immunizations, Dr. Boumpas said that renoprotection should receive attention in case of proteinuria and/or hypertension.

“With [sodium-glucose cotransporter 2] inhibitors, it’s a bit early. They’re promising, and you may consider them, although there are no data for patients with eGFR below 60 mL/min per 1.73 m²,” he remarked, completing his detailed discussion of the updated recommendations.

Dr. Boumpas reported no relevant financial relationships. Dr. Landewé served as past chair of EULAR’s Quality of Care Committee, which develops recommendations.

MILAN – Treatment of systemic lupus erythematosus with biologics may enable steroid tapering while ensuring the achievement of remission or low disease activity in more patients with fewer flares and less organ damage, as well as leading to better responses if used early, according to the latest recommendations on the management of SLE from the European Alliance of Associations for Rheumatology (EULAR).

Dimitrios Boumpas, MD, president of the Athens Medical Society and chair of the European Task force on SLE, presented the recommendations at the annual European Congress of Rheumatology. “Although steroids save lives, it is at the expense of excessive collateral damage. They are better for short-term use as a rescue or bridging therapy but may be used in some patients at 5 mg/day of prednisone or less, rather than the previous 7.5 mg/day,” he emphasized.

The 2023 recommendations cover new treatment strategies with more ambitious goals, new data on adverse effects of chronic glucocorticoid use, and newly approved agents and combination therapies.

“Most importantly, we sourced help from experts from all over the world,” said Dr. Boumpas, describing the task force that included 35 rheumatologists, 5 nephrologists, 2 methodologists, 2 patient representatives, and 2 fellows, all brought together from across Europe, North America, Asia, and Australia.

Over 7,000 papers were reviewed, with 437 included in the systematic literature review to inform the updated recommendations.

Session moderator Robert Landewé, MD, PhD, professor of clinical immunology and rheumatology at the University of Amsterdam, said that “the underlying heterogeneity and multisystem involvement of SLE can make it difficult to demonstrate and know which drugs work in the condition. However, these latest recommendations should encourage greater confidence to taper steroids early on and perhaps consider new biologic drugs, so that more patients can achieve better results sooner to prevent flares and organ damage, improve prognosis, and enhance their quality of life.”

Dr. Boumpas provided a summary of the overarching principles that guide the recommendations. These say that SLE requires multidisciplinary individualized management; disease activity should be assessed at each visit; nonpharmacologic interventions such as sun protection, smoking cessation, and following a healthy diet are all important for improving long-term outcomes; pharmacologic interventions are to be directed by patient characteristics, type and severity of organ involvement, treatment-related harms, and patient preferences, among other factors; and early SLE diagnosis is essential to prevent flares and organ damage, improve prognosis, and enhance quality of life.

Referring to each recommendation statement in turn, Dr. Boumpas provided a detailed description of each, and highlighted any changes since the 2019 recommendations.
 

Hydroxychloroquine, glucocorticoids as bridging therapy, and biologics

Referring to statement 1, Dr. Boumpas reported that hydroxychloroquine should be a first-line therapy at a dose of 5 mg/kg, but this dose should be individualized based on risk of flare and retinal toxicity. “There was some discussion about monitoring blood levels, but this was to ensure adherence only,” said Dr. Boumpas.

Continuing to statement 2, he added, “here is one change. With chronic use of glucocorticoids, the maintenance dose is 5 mg/day or less or prednisone equivalent. This pertains to both new onset and relapsing disease.” Previous recommendations advised a maintenance dose of 7.5 mg/day or less.

But he pointed out that “we are discussing using glucocorticoids in lupus as a bridging therapy only, for short, limited periods of time. We should shy away from chronic use of glucocorticoids and only use them for 3 months, and to do this we need to use glucocorticoid-sparing strategies.”

This led to statement 3, which refers to glucocorticoid-sparing strategies. Dr. Boumpas explained that, in patients who are not responding to hydroxychloroquine or unable to reduce glucocorticoids further during chronic use, add immunosuppressive agents, such as methotrexate and/or biologics (for example, belimumab [Benlysta] or anifrolumab [Saphnelo]).

“To allow flexibility for patients and clinicians, it isn’t necessary to use DMARDs [disease-modifying antirheumatic drugs] first if you prefer biologics,” he continued. “We are becoming more liberal with the use of biologics because there are new data that confirm the efficacy of belimumab in extrarenal SLE, plus good data with 3-year extension with anifrolumab.”

Statement 4 says that for patients with organ- or life-threatening disease, intravenous cyclophosphamide, “our old friend,” should be considered, while in refractory cases, rituximab may be considered, Dr. Boumpas said. “It’s okay to use cyclophosphamide. It isn’t a sin.”

Statement 5 refers to skin disease, and Dr. Boumpas explained that good data suggested that biologics help, including both belimumab and anifrolumab.

Nothing has changed with statement 6 concerning neuropsychiatric lupus, said Dr. Boumpas. “Glucocorticoids, immunosuppressive, and antithrombotic therapies should be considered.”

Regarding hematologic disease (statement 7), he said, “the new kid on the block is MMF [mycophenolate mofetil]. For acute treatment, still use the same drugs, including rituximab, but for maintenance you may use rituximab, azathioprine, MMF, or cyclosporine.”
 

Lupus nephritis

Turning to what Dr. Boumpas described as the “reason you had all come here, and what you had been waiting for ... what’s changing with lupus nephritis?” he said.

Statement 8 describes initial therapy in active lupus nephritis. Dr. Boumpas said that low-dose, intravenous cyclophosphamide or mycophenolate should be considered, but also that belimumab or a calcineurin inhibitor (CNI) should be considered at the start. The changes were based on two successful phase 3 trials of belimumab and voclosporin, with belimumab being associated with a reduced flare rate and estimated glomerular filtration rate (eGFR).

“Changes from 2019 include that there is no distinction between classes III/IV and V, which is heretical,” he stressed. Belimumab and CNIs/voclosporin should be considered in all patents as an add-on therapy from the start. “Lupus nephritis has high morbidity, and it’s difficult to predict outcomes at the beginning, but there are clear benefits of add-on therapies. CNIs, although they can be used for all patients, might be more appropriate for membranous or nephrotic-range proteinuria.”

He went on to announce that the “million-dollar question” was whether to use belimumab or voclosporin (or other CNIs), and that this was “a question of gentle, compared with forceful, power and collateral damage.

“For me, voclosporin works very fast, but you worry about side effects, while belimumab is gentle and the response is sustained, preventing flares and organ damage,” he said, adding that “our expert panel discussions showed that nephrologists were more eager to support steroid-free regimens.”

Moving on to statement 9, Dr. Boumpas explained that after initial therapy and renal response, subsequent therapy should continue for at least 3 years. If treated with MMF alone or in combination with belimumab, then these drugs should continue. However, MMF should replace cyclophosphamide if the latter is used initially.

Regarding treat-to-target in lupus nephritis, he said that EULAR now advises to aim for a 25% drop in urine protein/creatinine ratio by 3 months, a 50% drop by 6 months, and a UPCR of less than 0.5-0.7, plus normal eGFR, by 12 months, Dr. Boumpas said.

Statement 10 advises considering high-dose intravenous cyclophosphamide in combination with pulse intravenous methylprednisolone for patients at high risk of renal failure.
 

Tapering drugs in sustained remission, managing antiphospholipid syndrome, giving immunizations

Statement 11 suggests to consider tapering immunosuppressive agents and glucocorticoids in patients achieving sustained remission, starting with glucocorticoids first.

There was no change to statement 12, which recommends that thrombotic antiphospholipid syndrome associated with SLE be treated with long-term vitamin K antagonists.

Statement 13 addresses immunizations and adjunct therapies. In addition to conventional immunizations, Dr. Boumpas said that renoprotection should receive attention in case of proteinuria and/or hypertension.

“With [sodium-glucose cotransporter 2] inhibitors, it’s a bit early. They’re promising, and you may consider them, although there are no data for patients with eGFR below 60 mL/min per 1.73 m²,” he remarked, completing his detailed discussion of the updated recommendations.

Dr. Boumpas reported no relevant financial relationships. Dr. Landewé served as past chair of EULAR’s Quality of Care Committee, which develops recommendations.

MILAN – Treatment of systemic lupus erythematosus with biologics may enable steroid tapering while ensuring the achievement of remission or low disease activity in more patients with fewer flares and less organ damage, as well as leading to better responses if used early, according to the latest recommendations on the management of SLE from the European Alliance of Associations for Rheumatology (EULAR).

Dimitrios Boumpas, MD, president of the Athens Medical Society and chair of the European Task force on SLE, presented the recommendations at the annual European Congress of Rheumatology. “Although steroids save lives, it is at the expense of excessive collateral damage. They are better for short-term use as a rescue or bridging therapy but may be used in some patients at 5 mg/day of prednisone or less, rather than the previous 7.5 mg/day,” he emphasized.

The 2023 recommendations cover new treatment strategies with more ambitious goals, new data on adverse effects of chronic glucocorticoid use, and newly approved agents and combination therapies.

“Most importantly, we sourced help from experts from all over the world,” said Dr. Boumpas, describing the task force that included 35 rheumatologists, 5 nephrologists, 2 methodologists, 2 patient representatives, and 2 fellows, all brought together from across Europe, North America, Asia, and Australia.

Over 7,000 papers were reviewed, with 437 included in the systematic literature review to inform the updated recommendations.

Session moderator Robert Landewé, MD, PhD, professor of clinical immunology and rheumatology at the University of Amsterdam, said that “the underlying heterogeneity and multisystem involvement of SLE can make it difficult to demonstrate and know which drugs work in the condition. However, these latest recommendations should encourage greater confidence to taper steroids early on and perhaps consider new biologic drugs, so that more patients can achieve better results sooner to prevent flares and organ damage, improve prognosis, and enhance their quality of life.”

Dr. Boumpas provided a summary of the overarching principles that guide the recommendations. These say that SLE requires multidisciplinary individualized management; disease activity should be assessed at each visit; nonpharmacologic interventions such as sun protection, smoking cessation, and following a healthy diet are all important for improving long-term outcomes; pharmacologic interventions are to be directed by patient characteristics, type and severity of organ involvement, treatment-related harms, and patient preferences, among other factors; and early SLE diagnosis is essential to prevent flares and organ damage, improve prognosis, and enhance quality of life.

Referring to each recommendation statement in turn, Dr. Boumpas provided a detailed description of each, and highlighted any changes since the 2019 recommendations.
 

Hydroxychloroquine, glucocorticoids as bridging therapy, and biologics

Referring to statement 1, Dr. Boumpas reported that hydroxychloroquine should be a first-line therapy at a dose of 5 mg/kg, but this dose should be individualized based on risk of flare and retinal toxicity. “There was some discussion about monitoring blood levels, but this was to ensure adherence only,” said Dr. Boumpas.

Continuing to statement 2, he added, “here is one change. With chronic use of glucocorticoids, the maintenance dose is 5 mg/day or less or prednisone equivalent. This pertains to both new onset and relapsing disease.” Previous recommendations advised a maintenance dose of 7.5 mg/day or less.

But he pointed out that “we are discussing using glucocorticoids in lupus as a bridging therapy only, for short, limited periods of time. We should shy away from chronic use of glucocorticoids and only use them for 3 months, and to do this we need to use glucocorticoid-sparing strategies.”

This led to statement 3, which refers to glucocorticoid-sparing strategies. Dr. Boumpas explained that, in patients who are not responding to hydroxychloroquine or unable to reduce glucocorticoids further during chronic use, add immunosuppressive agents, such as methotrexate and/or biologics (for example, belimumab [Benlysta] or anifrolumab [Saphnelo]).

“To allow flexibility for patients and clinicians, it isn’t necessary to use DMARDs [disease-modifying antirheumatic drugs] first if you prefer biologics,” he continued. “We are becoming more liberal with the use of biologics because there are new data that confirm the efficacy of belimumab in extrarenal SLE, plus good data with 3-year extension with anifrolumab.”

Statement 4 says that for patients with organ- or life-threatening disease, intravenous cyclophosphamide, “our old friend,” should be considered, while in refractory cases, rituximab may be considered, Dr. Boumpas said. “It’s okay to use cyclophosphamide. It isn’t a sin.”

Statement 5 refers to skin disease, and Dr. Boumpas explained that good data suggested that biologics help, including both belimumab and anifrolumab.

Nothing has changed with statement 6 concerning neuropsychiatric lupus, said Dr. Boumpas. “Glucocorticoids, immunosuppressive, and antithrombotic therapies should be considered.”

Regarding hematologic disease (statement 7), he said, “the new kid on the block is MMF [mycophenolate mofetil]. For acute treatment, still use the same drugs, including rituximab, but for maintenance you may use rituximab, azathioprine, MMF, or cyclosporine.”
 

Lupus nephritis

Turning to what Dr. Boumpas described as the “reason you had all come here, and what you had been waiting for ... what’s changing with lupus nephritis?” he said.

Statement 8 describes initial therapy in active lupus nephritis. Dr. Boumpas said that low-dose, intravenous cyclophosphamide or mycophenolate should be considered, but also that belimumab or a calcineurin inhibitor (CNI) should be considered at the start. The changes were based on two successful phase 3 trials of belimumab and voclosporin, with belimumab being associated with a reduced flare rate and estimated glomerular filtration rate (eGFR).

“Changes from 2019 include that there is no distinction between classes III/IV and V, which is heretical,” he stressed. Belimumab and CNIs/voclosporin should be considered in all patents as an add-on therapy from the start. “Lupus nephritis has high morbidity, and it’s difficult to predict outcomes at the beginning, but there are clear benefits of add-on therapies. CNIs, although they can be used for all patients, might be more appropriate for membranous or nephrotic-range proteinuria.”

He went on to announce that the “million-dollar question” was whether to use belimumab or voclosporin (or other CNIs), and that this was “a question of gentle, compared with forceful, power and collateral damage.

“For me, voclosporin works very fast, but you worry about side effects, while belimumab is gentle and the response is sustained, preventing flares and organ damage,” he said, adding that “our expert panel discussions showed that nephrologists were more eager to support steroid-free regimens.”

Moving on to statement 9, Dr. Boumpas explained that after initial therapy and renal response, subsequent therapy should continue for at least 3 years. If treated with MMF alone or in combination with belimumab, then these drugs should continue. However, MMF should replace cyclophosphamide if the latter is used initially.

Regarding treat-to-target in lupus nephritis, he said that EULAR now advises to aim for a 25% drop in urine protein/creatinine ratio by 3 months, a 50% drop by 6 months, and a UPCR of less than 0.5-0.7, plus normal eGFR, by 12 months, Dr. Boumpas said.

Statement 10 advises considering high-dose intravenous cyclophosphamide in combination with pulse intravenous methylprednisolone for patients at high risk of renal failure.
 

Tapering drugs in sustained remission, managing antiphospholipid syndrome, giving immunizations

Statement 11 suggests to consider tapering immunosuppressive agents and glucocorticoids in patients achieving sustained remission, starting with glucocorticoids first.

There was no change to statement 12, which recommends that thrombotic antiphospholipid syndrome associated with SLE be treated with long-term vitamin K antagonists.

Statement 13 addresses immunizations and adjunct therapies. In addition to conventional immunizations, Dr. Boumpas said that renoprotection should receive attention in case of proteinuria and/or hypertension.

“With [sodium-glucose cotransporter 2] inhibitors, it’s a bit early. They’re promising, and you may consider them, although there are no data for patients with eGFR below 60 mL/min per 1.73 m²,” he remarked, completing his detailed discussion of the updated recommendations.

Dr. Boumpas reported no relevant financial relationships. Dr. Landewé served as past chair of EULAR’s Quality of Care Committee, which develops recommendations.

AT EULAR 2023

MILAN – Safety considerations, particularly regarding the use of Janus kinase (JAK) inhibitors, are of utmost importance in the 2023 update to recommendations for managing psoriatic arthritis (PsA) by the European Alliance of Associations for Rheumatology (EULAR). Additionally, the selection of therapy should now take into account the complete clinical presentation, explicitly considering nonmusculoskeletal manifestations.

Safety considerations with JAK inhibitors

Expanding on the existing six overarching principles from the 2019 recommendations, the PsA EULAR recommendations now introduce a seventh principle: “The choice of treatment should consider safety considerations regarding individual modes of action to optimize the benefit-risk profile.”

This addition was prompted by recent safety data on JAK inhibitors, which revealed serious potential side effects, such as heart attacks, blood clots, cancer, and severe infections, that recently prompted the European Medicines Agency to restrict their use. As indicated by the new principle, safety considerations have been incorporated into several recommendations.

For instance, in the context of peripheral arthritis, JAK inhibitors may now be considered if there is an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate, sulfasalazine, or leflunomide, and at least one biologic DMARD (bDMARD).

Alternatively, JAK inhibitors may be utilized when bDMARDs are not suitable for other reasons. However, EULAR now emphasizes caution whenever JAK inhibitors are mentioned. Specifically, “careful consideration is necessary for patients aged 65 or above, current or past long-time smokers, individuals with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, those with other malignancy risk factors, or individuals with a known risk for venous thromboembolism.”
 

Consider nonmusculoskeletal manifestations in treatment decisions

In another significant update, EULAR now recommends that the choice of therapy should also consider nonmusculoskeletal manifestations associated with PsA. “There is a notable shift in perspective here,” Dr. Gossec told this news organization. Clinically relevant skin involvement should prompt the use of IL-17A or IL-17A/F or IL-23 or IL-12/23 inhibitors, while uveitis should be treated with tumor necrosis factor (TNF) inhibitors.

In the case of inflammatory bowel disease, EULAR advises the use of anti-TNF agents, IL-12/23 or IL-23 inhibitors, or a JAK inhibitor. The recommended course of action within each treatment category is not ranked in order of preference, but EULAR emphasizes the importance of following EMA recommendations and considering safety.
 

Systemic glucocorticoids removed

Certain medications have been removed from the recommendations, reflecting the heightened focus on treatment safety. The use of systemic glucocorticoids as adjunctive therapy is no longer recommended. “We always had reservations about their use, and now we have eliminated them. We are aware that they are still utilized, with 30% of patients in Germany, for instance, receiving low doses of glucocorticoids. However, the long-term efficacy/safety balance of glucocorticoids is unfavorable in any disease, particularly in patients with psoriatic arthritis and multiple comorbidities,” Dr. Gossec explained.

NSAIDs and local glucocorticoids are now limited to specific patient populations, namely those affected by oligoarthritis without poor prognostic factors, entheseal disease, or predominant axial disease. Their use should be short-term, generally no longer than 4 weeks. Polyarthritis or oligoarthritis with poor prognostic factors should instead be treated directly with csDMARDs.
 

No specific biologic treatment order recommended for peripheral arthritis

Regarding patients with peripheral arthritis, recent efficacy data have led EULAR to refrain from recommending any specific order of preference for the use of bDMARDs, which encompass TNF inhibitors and drugs targeting the IL-17 and IL-12/23 pathways. “We lack the data to propose an order of preference in patients with peripheral arthritis. Different classes of molecules exhibit efficacy in joint inflammation, generally resulting in a 50% response rate and similar overall effects,” said Dr. Gossec, referencing head-to-head trials between biologics that yielded very comparable results, such as the EXCEED trial or SPIRIT-H2H trial.

The updated recommendations now consider two IL-23p19 inhibitors, guselkumab (Tremfya) and risankizumab (Skyrizi), the JAK inhibitor upadacitinib (Rinvoq), and the very recently EMA-approved bimekizumab (Bimzelx), an IL-17A/F double inhibitor.

The recommendation for patients with mono- or oligoarthritis and poor prognostic factors now aligns with the previous recommendations for polyarthritis: A csDMARD should be initiated promptly, with a preference for methotrexate if significant skin involvement is present. New data suggest that methotrexate may be beneficial for enthesitis, achieving resolution in approximately 30% of patients. When considering treatment options, JAK inhibitors may also be taken into account, with safety considerations in mind.

In cases of clinically relevant axial disease and an inadequate response to NSAIDs, therapy with an IL-17A inhibitor, a TNF inhibitor, an IL-17A/F inhibitor, or a JAK inhibitor may be considered. This approach now aligns with the most recent axial spondyloarthritis recommendation from EULAR and the Assessment of SpondyloArthritis international Society (ASAS).
 

Which disease manifestation to treat first?

During the discussion, chairwoman Uta Kiltz, MD, PhD, a rheumatologist at Rheumatism Center Ruhrgebiet, Herne, Germany, and clinical lecturer at Ruhr University Bochum, inquired about identifying the primary manifestation to guide the course of action.

“Psoriatic arthritis is highly heterogeneous, and determining the predominant manifestation is sometimes challenging,” Dr. Gossec said. “However, we believe that a certain order of preference is necessary when making treatment decisions. Starting with peripheral arthritis, which can lead to structural damage, allows for treatment selection based on that aspect. If peripheral arthritis is not present, attention should be directed towards axial disease, ensuring the presence of actual inflammation rather than solely axial pain, as mechanical origin axial pain can occur due to the patient’s age.”

David Liew, MBBS, PhD, consultant rheumatologist and clinical pharmacologist at Austin Health in Melbourne, commented on the update to this news organization: “We are fortunate to have a wide range of targeted therapy options for psoriatic arthritis, and these guidelines reflect this abundance of choices. They emphasize the importance of selecting therapies based on specific disease manifestations and tailoring care to each patient’s unique type of psoriatic arthritis. It’s worth noting that some changes in these guidelines were influenced by regulatory changes following ORAL Surveillance. In an era of numerous options, we can afford to be selective at times.”

Regarding safety concerns and JAK inhibitors, Dr. Liew added: “It is not surprising to see these guidelines impose certain restrictions on the use of JAK inhibitors, especially in psoriatic arthritis, where other therapies offer distinct advantages. Until high-quality evidence convincingly points away from a class effect, we can expect to see similar provisions in many more guidelines.”

Many of the recommendations’ authors report financial relationships with one or more pharmaceutical companies. These include AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Chugai, Galapagos, Gilead, GlaxoSmithKline, Janssen, Leo, Lilly, Medac, Merck, Merck Sharp & Dohme, Novartis, Pfizer, R-Pharma, Regeneron, Roche, Sandoz, Sanofi, Takeda, UCB, and Viatris.

EULAR funded the development of the recommendations.

A version of this article originally appeared on Medscape.com.

AT EULAR 2023

MILAN – Safety considerations, particularly regarding the use of Janus kinase (JAK) inhibitors, are of utmost importance in the 2023 update to recommendations for managing psoriatic arthritis (PsA) by the European Alliance of Associations for Rheumatology (EULAR). Additionally, the selection of therapy should now take into account the complete clinical presentation, explicitly considering nonmusculoskeletal manifestations.

Safety considerations with JAK inhibitors

Expanding on the existing six overarching principles from the 2019 recommendations, the PsA EULAR recommendations now introduce a seventh principle: “The choice of treatment should consider safety considerations regarding individual modes of action to optimize the benefit-risk profile.”

This addition was prompted by recent safety data on JAK inhibitors, which revealed serious potential side effects, such as heart attacks, blood clots, cancer, and severe infections, that recently prompted the European Medicines Agency to restrict their use. As indicated by the new principle, safety considerations have been incorporated into several recommendations.

For instance, in the context of peripheral arthritis, JAK inhibitors may now be considered if there is an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate, sulfasalazine, or leflunomide, and at least one biologic DMARD (bDMARD).

Alternatively, JAK inhibitors may be utilized when bDMARDs are not suitable for other reasons. However, EULAR now emphasizes caution whenever JAK inhibitors are mentioned. Specifically, “careful consideration is necessary for patients aged 65 or above, current or past long-time smokers, individuals with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, those with other malignancy risk factors, or individuals with a known risk for venous thromboembolism.”
 

Consider nonmusculoskeletal manifestations in treatment decisions

In another significant update, EULAR now recommends that the choice of therapy should also consider nonmusculoskeletal manifestations associated with PsA. “There is a notable shift in perspective here,” Dr. Gossec told this news organization. Clinically relevant skin involvement should prompt the use of IL-17A or IL-17A/F or IL-23 or IL-12/23 inhibitors, while uveitis should be treated with tumor necrosis factor (TNF) inhibitors.

In the case of inflammatory bowel disease, EULAR advises the use of anti-TNF agents, IL-12/23 or IL-23 inhibitors, or a JAK inhibitor. The recommended course of action within each treatment category is not ranked in order of preference, but EULAR emphasizes the importance of following EMA recommendations and considering safety.
 

Systemic glucocorticoids removed

Certain medications have been removed from the recommendations, reflecting the heightened focus on treatment safety. The use of systemic glucocorticoids as adjunctive therapy is no longer recommended. “We always had reservations about their use, and now we have eliminated them. We are aware that they are still utilized, with 30% of patients in Germany, for instance, receiving low doses of glucocorticoids. However, the long-term efficacy/safety balance of glucocorticoids is unfavorable in any disease, particularly in patients with psoriatic arthritis and multiple comorbidities,” Dr. Gossec explained.

NSAIDs and local glucocorticoids are now limited to specific patient populations, namely those affected by oligoarthritis without poor prognostic factors, entheseal disease, or predominant axial disease. Their use should be short-term, generally no longer than 4 weeks. Polyarthritis or oligoarthritis with poor prognostic factors should instead be treated directly with csDMARDs.
 

No specific biologic treatment order recommended for peripheral arthritis

Regarding patients with peripheral arthritis, recent efficacy data have led EULAR to refrain from recommending any specific order of preference for the use of bDMARDs, which encompass TNF inhibitors and drugs targeting the IL-17 and IL-12/23 pathways. “We lack the data to propose an order of preference in patients with peripheral arthritis. Different classes of molecules exhibit efficacy in joint inflammation, generally resulting in a 50% response rate and similar overall effects,” said Dr. Gossec, referencing head-to-head trials between biologics that yielded very comparable results, such as the EXCEED trial or SPIRIT-H2H trial.

The updated recommendations now consider two IL-23p19 inhibitors, guselkumab (Tremfya) and risankizumab (Skyrizi), the JAK inhibitor upadacitinib (Rinvoq), and the very recently EMA-approved bimekizumab (Bimzelx), an IL-17A/F double inhibitor.

The recommendation for patients with mono- or oligoarthritis and poor prognostic factors now aligns with the previous recommendations for polyarthritis: A csDMARD should be initiated promptly, with a preference for methotrexate if significant skin involvement is present. New data suggest that methotrexate may be beneficial for enthesitis, achieving resolution in approximately 30% of patients. When considering treatment options, JAK inhibitors may also be taken into account, with safety considerations in mind.

In cases of clinically relevant axial disease and an inadequate response to NSAIDs, therapy with an IL-17A inhibitor, a TNF inhibitor, an IL-17A/F inhibitor, or a JAK inhibitor may be considered. This approach now aligns with the most recent axial spondyloarthritis recommendation from EULAR and the Assessment of SpondyloArthritis international Society (ASAS).
 

Which disease manifestation to treat first?

During the discussion, chairwoman Uta Kiltz, MD, PhD, a rheumatologist at Rheumatism Center Ruhrgebiet, Herne, Germany, and clinical lecturer at Ruhr University Bochum, inquired about identifying the primary manifestation to guide the course of action.

“Psoriatic arthritis is highly heterogeneous, and determining the predominant manifestation is sometimes challenging,” Dr. Gossec said. “However, we believe that a certain order of preference is necessary when making treatment decisions. Starting with peripheral arthritis, which can lead to structural damage, allows for treatment selection based on that aspect. If peripheral arthritis is not present, attention should be directed towards axial disease, ensuring the presence of actual inflammation rather than solely axial pain, as mechanical origin axial pain can occur due to the patient’s age.”

David Liew, MBBS, PhD, consultant rheumatologist and clinical pharmacologist at Austin Health in Melbourne, commented on the update to this news organization: “We are fortunate to have a wide range of targeted therapy options for psoriatic arthritis, and these guidelines reflect this abundance of choices. They emphasize the importance of selecting therapies based on specific disease manifestations and tailoring care to each patient’s unique type of psoriatic arthritis. It’s worth noting that some changes in these guidelines were influenced by regulatory changes following ORAL Surveillance. In an era of numerous options, we can afford to be selective at times.”

Regarding safety concerns and JAK inhibitors, Dr. Liew added: “It is not surprising to see these guidelines impose certain restrictions on the use of JAK inhibitors, especially in psoriatic arthritis, where other therapies offer distinct advantages. Until high-quality evidence convincingly points away from a class effect, we can expect to see similar provisions in many more guidelines.”

Many of the recommendations’ authors report financial relationships with one or more pharmaceutical companies. These include AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Chugai, Galapagos, Gilead, GlaxoSmithKline, Janssen, Leo, Lilly, Medac, Merck, Merck Sharp & Dohme, Novartis, Pfizer, R-Pharma, Regeneron, Roche, Sandoz, Sanofi, Takeda, UCB, and Viatris.

EULAR funded the development of the recommendations.

A version of this article originally appeared on Medscape.com.

AT EULAR 2023

MILAN – Safety considerations, particularly regarding the use of Janus kinase (JAK) inhibitors, are of utmost importance in the 2023 update to recommendations for managing psoriatic arthritis (PsA) by the European Alliance of Associations for Rheumatology (EULAR). Additionally, the selection of therapy should now take into account the complete clinical presentation, explicitly considering nonmusculoskeletal manifestations.

Safety considerations with JAK inhibitors

Expanding on the existing six overarching principles from the 2019 recommendations, the PsA EULAR recommendations now introduce a seventh principle: “The choice of treatment should consider safety considerations regarding individual modes of action to optimize the benefit-risk profile.”

This addition was prompted by recent safety data on JAK inhibitors, which revealed serious potential side effects, such as heart attacks, blood clots, cancer, and severe infections, that recently prompted the European Medicines Agency to restrict their use. As indicated by the new principle, safety considerations have been incorporated into several recommendations.

For instance, in the context of peripheral arthritis, JAK inhibitors may now be considered if there is an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) such as methotrexate, sulfasalazine, or leflunomide, and at least one biologic DMARD (bDMARD).

Alternatively, JAK inhibitors may be utilized when bDMARDs are not suitable for other reasons. However, EULAR now emphasizes caution whenever JAK inhibitors are mentioned. Specifically, “careful consideration is necessary for patients aged 65 or above, current or past long-time smokers, individuals with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, those with other malignancy risk factors, or individuals with a known risk for venous thromboembolism.”
 

Consider nonmusculoskeletal manifestations in treatment decisions

In another significant update, EULAR now recommends that the choice of therapy should also consider nonmusculoskeletal manifestations associated with PsA. “There is a notable shift in perspective here,” Dr. Gossec told this news organization. Clinically relevant skin involvement should prompt the use of IL-17A or IL-17A/F or IL-23 or IL-12/23 inhibitors, while uveitis should be treated with tumor necrosis factor (TNF) inhibitors.

In the case of inflammatory bowel disease, EULAR advises the use of anti-TNF agents, IL-12/23 or IL-23 inhibitors, or a JAK inhibitor. The recommended course of action within each treatment category is not ranked in order of preference, but EULAR emphasizes the importance of following EMA recommendations and considering safety.
 

Systemic glucocorticoids removed

Certain medications have been removed from the recommendations, reflecting the heightened focus on treatment safety. The use of systemic glucocorticoids as adjunctive therapy is no longer recommended. “We always had reservations about their use, and now we have eliminated them. We are aware that they are still utilized, with 30% of patients in Germany, for instance, receiving low doses of glucocorticoids. However, the long-term efficacy/safety balance of glucocorticoids is unfavorable in any disease, particularly in patients with psoriatic arthritis and multiple comorbidities,” Dr. Gossec explained.

NSAIDs and local glucocorticoids are now limited to specific patient populations, namely those affected by oligoarthritis without poor prognostic factors, entheseal disease, or predominant axial disease. Their use should be short-term, generally no longer than 4 weeks. Polyarthritis or oligoarthritis with poor prognostic factors should instead be treated directly with csDMARDs.
 

No specific biologic treatment order recommended for peripheral arthritis

Regarding patients with peripheral arthritis, recent efficacy data have led EULAR to refrain from recommending any specific order of preference for the use of bDMARDs, which encompass TNF inhibitors and drugs targeting the IL-17 and IL-12/23 pathways. “We lack the data to propose an order of preference in patients with peripheral arthritis. Different classes of molecules exhibit efficacy in joint inflammation, generally resulting in a 50% response rate and similar overall effects,” said Dr. Gossec, referencing head-to-head trials between biologics that yielded very comparable results, such as the EXCEED trial or SPIRIT-H2H trial.

The updated recommendations now consider two IL-23p19 inhibitors, guselkumab (Tremfya) and risankizumab (Skyrizi), the JAK inhibitor upadacitinib (Rinvoq), and the very recently EMA-approved bimekizumab (Bimzelx), an IL-17A/F double inhibitor.

The recommendation for patients with mono- or oligoarthritis and poor prognostic factors now aligns with the previous recommendations for polyarthritis: A csDMARD should be initiated promptly, with a preference for methotrexate if significant skin involvement is present. New data suggest that methotrexate may be beneficial for enthesitis, achieving resolution in approximately 30% of patients. When considering treatment options, JAK inhibitors may also be taken into account, with safety considerations in mind.

In cases of clinically relevant axial disease and an inadequate response to NSAIDs, therapy with an IL-17A inhibitor, a TNF inhibitor, an IL-17A/F inhibitor, or a JAK inhibitor may be considered. This approach now aligns with the most recent axial spondyloarthritis recommendation from EULAR and the Assessment of SpondyloArthritis international Society (ASAS).
 

Which disease manifestation to treat first?

During the discussion, chairwoman Uta Kiltz, MD, PhD, a rheumatologist at Rheumatism Center Ruhrgebiet, Herne, Germany, and clinical lecturer at Ruhr University Bochum, inquired about identifying the primary manifestation to guide the course of action.

“Psoriatic arthritis is highly heterogeneous, and determining the predominant manifestation is sometimes challenging,” Dr. Gossec said. “However, we believe that a certain order of preference is necessary when making treatment decisions. Starting with peripheral arthritis, which can lead to structural damage, allows for treatment selection based on that aspect. If peripheral arthritis is not present, attention should be directed towards axial disease, ensuring the presence of actual inflammation rather than solely axial pain, as mechanical origin axial pain can occur due to the patient’s age.”

David Liew, MBBS, PhD, consultant rheumatologist and clinical pharmacologist at Austin Health in Melbourne, commented on the update to this news organization: “We are fortunate to have a wide range of targeted therapy options for psoriatic arthritis, and these guidelines reflect this abundance of choices. They emphasize the importance of selecting therapies based on specific disease manifestations and tailoring care to each patient’s unique type of psoriatic arthritis. It’s worth noting that some changes in these guidelines were influenced by regulatory changes following ORAL Surveillance. In an era of numerous options, we can afford to be selective at times.”

Regarding safety concerns and JAK inhibitors, Dr. Liew added: “It is not surprising to see these guidelines impose certain restrictions on the use of JAK inhibitors, especially in psoriatic arthritis, where other therapies offer distinct advantages. Until high-quality evidence convincingly points away from a class effect, we can expect to see similar provisions in many more guidelines.”

Many of the recommendations’ authors report financial relationships with one or more pharmaceutical companies. These include AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Chugai, Galapagos, Gilead, GlaxoSmithKline, Janssen, Leo, Lilly, Medac, Merck, Merck Sharp & Dohme, Novartis, Pfizer, R-Pharma, Regeneron, Roche, Sandoz, Sanofi, Takeda, UCB, and Viatris.

EULAR funded the development of the recommendations.

A version of this article originally appeared on Medscape.com.

MILAN – Targeted synthetic and biologic therapies are recommended as disease-modifying agents for key fibrotic manifestations of systemic sclerosis for the first time in the 2023 update of European Alliance of Associations for Rheumatology recommendations for the treatment of systemic sclerosis.

Reflecting important advances over the past 8 years, mostly relating to the use of new treatments being made available to patients, the recommendations provide an update on the 2017 recommendations, which relied on evidence published through 2014. Of note, these include the use of immunosuppressive agents, for example, the monoclonal antibody rituximab (Rituxan) for skin and lung fibrosis.

“For the first time, synthetic and targeted treatments are recommended for the treatment of systemic sclerosis–interstitial lung disease, including mycophenolate mofetil [Cellcept], nintedanib [Ofev], rituximab, and tocilizumab [Actemra]. None of these were present in 2017. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not present in 2017,” Francesco Del Galdo, MD, rheumatology consultant at Leeds Teaching Hospital NHS Trust, Leeds, England, and member of the 2023 recommendations task force, said in an interview. He gave an overview of the preliminary recommendations at the annual European Congress of Rheumatology.

“Phosphodiesterase-5 [PDE-5] inhibitors and endothelin receptor antagonist [ERA] monotherapy are also recommended for up-front combination use for digital ulcers and pulmonary hypertension, and this is new for 2023 and was not present in the 2017 recommendations,” Dr. Del Galdo added.

The new recommendations also note that iloprost is categorized as having grade A evidence for use in Raynaud’s phenomenon and digital ulcers, while it has grade B evidence for pulmonary hypertension.

“We are not allowed to share the final table [of recommendations] today because the wording has only very recently been agreed” upon, Dr. Del Galdo said, but he provided a summary representation and reflected on some changes, noting that the task force is aiming to publish the 2023 recommendations by the end of the year.

Consideration and discussion of both established and new evidence highlighted a need for more evidence on the use of immunosuppressive agents in vascular manifestations of systemic sclerosis, as well as for gastrointestinal and musculoskeletal ones.

In this update to the 2017 recommendations, high-grade evidence was identified for use of immunosuppressants in skin and lung fibrosis. Grade A evidence has been accepted for the use of rituximab in skin fibrosis; for interstitial lung disease, rituximab, cyclophosphamide, and nintedanib also have grade A evidence, which is a change from the 2017 recommendations.

A total of 20 updated recommendations were agreed on, an increase from 16 in 2017. These were grouped into eight disease domains: Raynaud’s phenomenon, digital ulcers, pulmonary arterial hypertension, skin fibrosis, interstitial lung disease, musculoskeletal and gastrointestinal manifestations, and renal crisis. Interventions were then graded A-D based on the evidence reviewed.

“This approach allowed us to see clearly that there were patterns of similar recommendations in different organ manifestations, reflecting an understanding of common pathogenic pathways,” said Dr. Del Galdo.

He also noted that the development of the recommendations highlighted certain gaps in research that limit treatment options. “By grouping the recommendations in blocks – for example, skin fibrosis or vascular [manifestations] – we show that immunosuppressive treatments have only been studied in skin and lung, while vascular manifestations have very little evidence for immunosuppression. They might be effective but there’s no evidence yet [hence no recommendation in vascular manifestations].”

“Also, there’s no grade A evidence at all for musculoskeletal and gastrointestinal manifestations, and this should help to define the research agenda going forward,” Dr. Del Galdo said.

The 2023 recommendations task force comprised 28 members from 14 countries, including 18 rheumatologists, 1 EULAR methodologist, 1 health professional representative, 5 rheumatology fellows, 1 librarian, and 2 patient representatives. They used a consensual approach incorporating the views of 101 European Scleroderma Trials and Research group (EUSTAR) centers, sourced via a survey in which questions were advanced to an extensive systematic review if there was 70% or greater agreement.

Eventually, 31 questions on interventions were chosen, and the task force reviewed 12,500 abstracts (up to December 2022) related to interventions and outcomes that were either included in the 2017 recommendations or were totally new.

Dr. Del Galdo said that the three vascular manifestations of scleroderma – Raynaud’s, pulmonary arterial hypertension, and digital ulcers – were treated with the same drugs, all with a similar grade of evidence. “This suggests two things – firstly there’s a vascular disease continuum in the disease, and secondly, we’ve borrowed these drugs from vascular community, but we have not yet tested synthetic and biologic targeted treatments in these manifestations, and we should.

“Treating one manifestation may benefit the other, and this is important time wise because pulmonary hypertension usually comes around 10 years after the first phenomena so by treating digital ulcers and Raynaud’s phenomena, we may prevent pulmonary hypertension, but a study is needed,” added Dr. Del Galdo, who is also president of EUSTAR.

Finally, he pointed out that research remains particularly open for nonpharmacologic treatments for digital ulcers and severe gastrointestinal involvement. “Patients can now ask for studies into this because of the current lack of evidence.”

Moderator Ariane Herrick, PhD, professor of rheumatology at the University of Manchester (England), shared her thoughts on the guidelines. “These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.”

Commenting on the paucity of evidence in some areas, she added that “there do remain some huge areas of unmet need that are difficult to address, and these are musculoskeletal, gastrointestinal, and calcinosis, for which there have been no trials at all.”

Dr. Del Galdo declared disclosures relating to AstraZeneca, Janssen, Boehringer Ingelheim, Capella, Chemomab, GlaxoSmithKline, and Mitsubishi-Tanabe. Dr. Herrick disclosed serving as a consultant for Boehringer Ingelheim and Janssen.

MILAN – Targeted synthetic and biologic therapies are recommended as disease-modifying agents for key fibrotic manifestations of systemic sclerosis for the first time in the 2023 update of European Alliance of Associations for Rheumatology recommendations for the treatment of systemic sclerosis.

Reflecting important advances over the past 8 years, mostly relating to the use of new treatments being made available to patients, the recommendations provide an update on the 2017 recommendations, which relied on evidence published through 2014. Of note, these include the use of immunosuppressive agents, for example, the monoclonal antibody rituximab (Rituxan) for skin and lung fibrosis.

“For the first time, synthetic and targeted treatments are recommended for the treatment of systemic sclerosis–interstitial lung disease, including mycophenolate mofetil [Cellcept], nintedanib [Ofev], rituximab, and tocilizumab [Actemra]. None of these were present in 2017. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not present in 2017,” Francesco Del Galdo, MD, rheumatology consultant at Leeds Teaching Hospital NHS Trust, Leeds, England, and member of the 2023 recommendations task force, said in an interview. He gave an overview of the preliminary recommendations at the annual European Congress of Rheumatology.

“Phosphodiesterase-5 [PDE-5] inhibitors and endothelin receptor antagonist [ERA] monotherapy are also recommended for up-front combination use for digital ulcers and pulmonary hypertension, and this is new for 2023 and was not present in the 2017 recommendations,” Dr. Del Galdo added.

The new recommendations also note that iloprost is categorized as having grade A evidence for use in Raynaud’s phenomenon and digital ulcers, while it has grade B evidence for pulmonary hypertension.

“We are not allowed to share the final table [of recommendations] today because the wording has only very recently been agreed” upon, Dr. Del Galdo said, but he provided a summary representation and reflected on some changes, noting that the task force is aiming to publish the 2023 recommendations by the end of the year.

Consideration and discussion of both established and new evidence highlighted a need for more evidence on the use of immunosuppressive agents in vascular manifestations of systemic sclerosis, as well as for gastrointestinal and musculoskeletal ones.

In this update to the 2017 recommendations, high-grade evidence was identified for use of immunosuppressants in skin and lung fibrosis. Grade A evidence has been accepted for the use of rituximab in skin fibrosis; for interstitial lung disease, rituximab, cyclophosphamide, and nintedanib also have grade A evidence, which is a change from the 2017 recommendations.

A total of 20 updated recommendations were agreed on, an increase from 16 in 2017. These were grouped into eight disease domains: Raynaud’s phenomenon, digital ulcers, pulmonary arterial hypertension, skin fibrosis, interstitial lung disease, musculoskeletal and gastrointestinal manifestations, and renal crisis. Interventions were then graded A-D based on the evidence reviewed.

“This approach allowed us to see clearly that there were patterns of similar recommendations in different organ manifestations, reflecting an understanding of common pathogenic pathways,” said Dr. Del Galdo.

He also noted that the development of the recommendations highlighted certain gaps in research that limit treatment options. “By grouping the recommendations in blocks – for example, skin fibrosis or vascular [manifestations] – we show that immunosuppressive treatments have only been studied in skin and lung, while vascular manifestations have very little evidence for immunosuppression. They might be effective but there’s no evidence yet [hence no recommendation in vascular manifestations].”

“Also, there’s no grade A evidence at all for musculoskeletal and gastrointestinal manifestations, and this should help to define the research agenda going forward,” Dr. Del Galdo said.

The 2023 recommendations task force comprised 28 members from 14 countries, including 18 rheumatologists, 1 EULAR methodologist, 1 health professional representative, 5 rheumatology fellows, 1 librarian, and 2 patient representatives. They used a consensual approach incorporating the views of 101 European Scleroderma Trials and Research group (EUSTAR) centers, sourced via a survey in which questions were advanced to an extensive systematic review if there was 70% or greater agreement.

Eventually, 31 questions on interventions were chosen, and the task force reviewed 12,500 abstracts (up to December 2022) related to interventions and outcomes that were either included in the 2017 recommendations or were totally new.

Dr. Del Galdo said that the three vascular manifestations of scleroderma – Raynaud’s, pulmonary arterial hypertension, and digital ulcers – were treated with the same drugs, all with a similar grade of evidence. “This suggests two things – firstly there’s a vascular disease continuum in the disease, and secondly, we’ve borrowed these drugs from vascular community, but we have not yet tested synthetic and biologic targeted treatments in these manifestations, and we should.

“Treating one manifestation may benefit the other, and this is important time wise because pulmonary hypertension usually comes around 10 years after the first phenomena so by treating digital ulcers and Raynaud’s phenomena, we may prevent pulmonary hypertension, but a study is needed,” added Dr. Del Galdo, who is also president of EUSTAR.

Finally, he pointed out that research remains particularly open for nonpharmacologic treatments for digital ulcers and severe gastrointestinal involvement. “Patients can now ask for studies into this because of the current lack of evidence.”

Moderator Ariane Herrick, PhD, professor of rheumatology at the University of Manchester (England), shared her thoughts on the guidelines. “These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.”

Commenting on the paucity of evidence in some areas, she added that “there do remain some huge areas of unmet need that are difficult to address, and these are musculoskeletal, gastrointestinal, and calcinosis, for which there have been no trials at all.”

Dr. Del Galdo declared disclosures relating to AstraZeneca, Janssen, Boehringer Ingelheim, Capella, Chemomab, GlaxoSmithKline, and Mitsubishi-Tanabe. Dr. Herrick disclosed serving as a consultant for Boehringer Ingelheim and Janssen.

MILAN – Targeted synthetic and biologic therapies are recommended as disease-modifying agents for key fibrotic manifestations of systemic sclerosis for the first time in the 2023 update of European Alliance of Associations for Rheumatology recommendations for the treatment of systemic sclerosis.

Reflecting important advances over the past 8 years, mostly relating to the use of new treatments being made available to patients, the recommendations provide an update on the 2017 recommendations, which relied on evidence published through 2014. Of note, these include the use of immunosuppressive agents, for example, the monoclonal antibody rituximab (Rituxan) for skin and lung fibrosis.

“For the first time, synthetic and targeted treatments are recommended for the treatment of systemic sclerosis–interstitial lung disease, including mycophenolate mofetil [Cellcept], nintedanib [Ofev], rituximab, and tocilizumab [Actemra]. None of these were present in 2017. Mycophenolate mofetil is also recommended for the treatment of skin fibrosis, and this was not present in 2017,” Francesco Del Galdo, MD, rheumatology consultant at Leeds Teaching Hospital NHS Trust, Leeds, England, and member of the 2023 recommendations task force, said in an interview. He gave an overview of the preliminary recommendations at the annual European Congress of Rheumatology.

“Phosphodiesterase-5 [PDE-5] inhibitors and endothelin receptor antagonist [ERA] monotherapy are also recommended for up-front combination use for digital ulcers and pulmonary hypertension, and this is new for 2023 and was not present in the 2017 recommendations,” Dr. Del Galdo added.

The new recommendations also note that iloprost is categorized as having grade A evidence for use in Raynaud’s phenomenon and digital ulcers, while it has grade B evidence for pulmonary hypertension.

“We are not allowed to share the final table [of recommendations] today because the wording has only very recently been agreed” upon, Dr. Del Galdo said, but he provided a summary representation and reflected on some changes, noting that the task force is aiming to publish the 2023 recommendations by the end of the year.

Consideration and discussion of both established and new evidence highlighted a need for more evidence on the use of immunosuppressive agents in vascular manifestations of systemic sclerosis, as well as for gastrointestinal and musculoskeletal ones.

In this update to the 2017 recommendations, high-grade evidence was identified for use of immunosuppressants in skin and lung fibrosis. Grade A evidence has been accepted for the use of rituximab in skin fibrosis; for interstitial lung disease, rituximab, cyclophosphamide, and nintedanib also have grade A evidence, which is a change from the 2017 recommendations.

A total of 20 updated recommendations were agreed on, an increase from 16 in 2017. These were grouped into eight disease domains: Raynaud’s phenomenon, digital ulcers, pulmonary arterial hypertension, skin fibrosis, interstitial lung disease, musculoskeletal and gastrointestinal manifestations, and renal crisis. Interventions were then graded A-D based on the evidence reviewed.

“This approach allowed us to see clearly that there were patterns of similar recommendations in different organ manifestations, reflecting an understanding of common pathogenic pathways,” said Dr. Del Galdo.

He also noted that the development of the recommendations highlighted certain gaps in research that limit treatment options. “By grouping the recommendations in blocks – for example, skin fibrosis or vascular [manifestations] – we show that immunosuppressive treatments have only been studied in skin and lung, while vascular manifestations have very little evidence for immunosuppression. They might be effective but there’s no evidence yet [hence no recommendation in vascular manifestations].”

“Also, there’s no grade A evidence at all for musculoskeletal and gastrointestinal manifestations, and this should help to define the research agenda going forward,” Dr. Del Galdo said.

The 2023 recommendations task force comprised 28 members from 14 countries, including 18 rheumatologists, 1 EULAR methodologist, 1 health professional representative, 5 rheumatology fellows, 1 librarian, and 2 patient representatives. They used a consensual approach incorporating the views of 101 European Scleroderma Trials and Research group (EUSTAR) centers, sourced via a survey in which questions were advanced to an extensive systematic review if there was 70% or greater agreement.

Eventually, 31 questions on interventions were chosen, and the task force reviewed 12,500 abstracts (up to December 2022) related to interventions and outcomes that were either included in the 2017 recommendations or were totally new.

Dr. Del Galdo said that the three vascular manifestations of scleroderma – Raynaud’s, pulmonary arterial hypertension, and digital ulcers – were treated with the same drugs, all with a similar grade of evidence. “This suggests two things – firstly there’s a vascular disease continuum in the disease, and secondly, we’ve borrowed these drugs from vascular community, but we have not yet tested synthetic and biologic targeted treatments in these manifestations, and we should.

“Treating one manifestation may benefit the other, and this is important time wise because pulmonary hypertension usually comes around 10 years after the first phenomena so by treating digital ulcers and Raynaud’s phenomena, we may prevent pulmonary hypertension, but a study is needed,” added Dr. Del Galdo, who is also president of EUSTAR.

Finally, he pointed out that research remains particularly open for nonpharmacologic treatments for digital ulcers and severe gastrointestinal involvement. “Patients can now ask for studies into this because of the current lack of evidence.”

Moderator Ariane Herrick, PhD, professor of rheumatology at the University of Manchester (England), shared her thoughts on the guidelines. “These recommendations have been long awaited by the scleroderma community because there has been some exciting progress in recent years, and the new recommendations reflect these new developments.”

Commenting on the paucity of evidence in some areas, she added that “there do remain some huge areas of unmet need that are difficult to address, and these are musculoskeletal, gastrointestinal, and calcinosis, for which there have been no trials at all.”

Dr. Del Galdo declared disclosures relating to AstraZeneca, Janssen, Boehringer Ingelheim, Capella, Chemomab, GlaxoSmithKline, and Mitsubishi-Tanabe. Dr. Herrick disclosed serving as a consultant for Boehringer Ingelheim and Janssen.

Douglas Lunsford’s son Samuel has struggled with obesity all his life.

Just before turning 14, Samuel, now 25, took part in a program at Ohio-based Nationwide Children’s Hospital’s Center for Healthy Weight and Nutrition. The program consisted of twice-weekly meetings with a nutritionist, including lessons in food portion size, what food does within the body, what foods can be used to supplement other foods, and similar topics, as well as physical exercise. 

Although the program was designed for youngsters with weight problems, Mr. Lunsford also took part. 

“They would exercise us and work us out,” he said.

Father and son did the program together for 2 years. Since then, Mr. Lunsford has advocated for youngsters with obesity. 

“Samuel’s struggle spurred us into action,” he said. 

Eventually, Mr. Lunsford helped create the American Academy of Pediatrics’ recently released Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. 
 

Helping create change

According to Sandra Hassink, MD, coauthor of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, the goal was to “help patients make changes in lifestyle, behaviors, or environment in a sustainable way and also to involve families in decision-making at every step of the way.”

The guideline recommends comprehensive obesity treatment that may include nutritional support, exercise, behavioral therapy, medication, and metabolic and bariatric surgery.

Ideally, a child would receive intense behavioral and lifestyle treatment, although this approach isn’t always available and might be challenging to deliver. The most effective treatments include at least 26 hours of face-to-face, family-based treatments, consisting of many different components and lasting 3-12 months.

The guideline suggests that doctors offer adolescents 12 and older medication to assist in weight loss, along with health, behavior, and lifestyle treatment, and that teens who have severe obesity should consider metabolic and bariatric surgery as they continue intense health behavior and lifestyle treatment. 

“We’re living at a time where we’ve watched obesity affect our children and adult population for 4 decades and, along with the risk of obesity, we’ve watched a rise in obesity; we’re seeing increases in illness that go along with obesity, such as type 2 diabetes, lipid diseases like high cholesterol, and nonalcoholic fatty liver disease,” Dr. Hassink said.

She explained that, as people gain weight, the cells in adipose (fatty) tissues start to malfunction and produce inflammatory chemicals that cause these illnesses. 

“So having extra adipose tissue is a risk,” she said. “As pediatricians, we measure body mass index [BMI] – which is calculated based on height and weight – as a way of seeing whether the child could be at risk for developing these dysfunctioning cells. If so, we screen them for prediabetes, lipid disease, or liver disease and other obesity-related comorbidities.”

In addition, “we’re concerned about the mental health of children with obesity because of the weight bias in our culture,” said Dr. Hassink. “A child gets stigmatized, and this takes the form of bullying and teasing, and leads to low self-esteem, depression, and anxiety. So we know we have a host of physical problems we need to look out for, as well as the emotional and psychological effects of how our culture views things.”
 

Are parents ready for the new approach?

A new report from Harmony Healthcare IT, a data management firm that works with health data, looked at how parents regard their children’s obesity. The company surveyed more than 1,000 parents and found that one-tenth of respondents had children who were overweight or obese and over a quarter (26%) worried about their child’s weight.

Nearly 40% of parents would consider weight loss medication for their child if the child became obese at age 12, and about 16% would consider weight loss surgery. But most parents would not consider this surgery until their child was an average age of 15 rather than the AAP’s recommended age of 13.

Mr. Lunsford said that his son considered surgery and medication but was “never comfortable” with these approaches. 

This isn’t unusual, Dr. Hassink said. “Not every parent will think the same way, and their view will be based on their experience and what’s going on with their child.”

The guideline wasn’t designed to encourage every child to try medication or have surgery, she said. 

“But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician.”
 

Challenges to keeping healthy

It’s tough to stay healthy and not develop obesity in our modern environment, Dr. Hassink said. 

“There’s a lot of processed food, a lot of sugar in our foods, a lot of sedentary behavior, and a decrease in physical activity. In many communities, it’s hard for people to get healthy foods.”

Mr. Lunsford said that when his son was in his late teens and would go out with friends, they typically went to fast-food restaurants. 

“Sam would say ‘yes’ to these foods, although he knew they weren’t good for him, because he wanted to be like everyone else,” he said.

But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician, he said.

Harmony Health IT’s survey found that many parents say it is a struggle to get kids to eat healthy foods and get enough sleep. Although almost all respondents (83%) said they try to prepare healthy, home-cooked meals, 39% eat fast food at least once a week, mostly because parents are too tired to cook. 

Dr. Hassink said the COVID-19 pandemic also played a role.

“We knew that COVID would be hard for kids with obesity, and there might be weight gain because of the extra sedentary time and fewer sporting activities, and there was a high cost of food to families who are already economically strapped,” she said. 

In general, family support is essential, Dr. Hassink said. “Obesity treatment requires that the family be involved. The family is living in the same nutritional and activity environment as their child. Everyone has to be on board.”
 

Talking to kids about food and weight

The survey found that many parents struggle to talk about food and weight with their children. The AAP guideline notes that involving a health care professional can help. 

“If a parent or caregiver is concerned about a child’s weight, he or she can take the child to their pediatrician,” Dr. Hassink said. “The first thing the pediatrician will do is ask about the child’s overall health, review the family history – because obesity tends to run in families – and see if other conditions, like diabetes, also run in the family.” 

The pediatrician will do a physical examination that includes BMI and, if it’s high, other tests looking at blood sugar, lipids, and liver function may be performed. 

Ideally, the child will be prescribed intense lifestyle and behavioral treatment that will take the child’s and family’s nutrition into account, as well as physical activity and the amount of sleep the child is getting, which is sometimes tied to weight gain. If the child has disordered eating, such as binge eating disorder, they can be evaluated and treated for that.

Each child is seen as an individual with a particular set of needs. “One size doesn’t fit all,” Dr. Hassink said. 
 

Providing emotional support for children with obesity 

Pediatricians can assess the child’s mental, emotional, and social well-being. “Children who are bullied or teased may need help working through that. Children experiencing depression may need treatment,” Dr. Hassink said.

Mr. Lunsford said Samuel was fortunate in that he rarely got taunted. 

“Part of the reason is that, although weight was an issue, he never allowed his weight to define him,” he said. “He was always an extroverted kind of kid, athletic, very outgoing and friendly, and being overweight was never part of his identity.” 

Mr. Lunsford encourages parents whose children are teased or bullied to create a “no-judgment” zone at home. 

“Let your kids know that their parents love them for who they are,” he said. “Emphasize that weight is a ‘number’ and health is a ‘lifestyle.’ Try to highlight the good things in their lives and encourage them to be as active as they can in the things that interest them.”

A version of this article originally appeared on WebMD.com.

Douglas Lunsford’s son Samuel has struggled with obesity all his life.

Just before turning 14, Samuel, now 25, took part in a program at Ohio-based Nationwide Children’s Hospital’s Center for Healthy Weight and Nutrition. The program consisted of twice-weekly meetings with a nutritionist, including lessons in food portion size, what food does within the body, what foods can be used to supplement other foods, and similar topics, as well as physical exercise. 

Although the program was designed for youngsters with weight problems, Mr. Lunsford also took part. 

“They would exercise us and work us out,” he said.

Father and son did the program together for 2 years. Since then, Mr. Lunsford has advocated for youngsters with obesity. 

“Samuel’s struggle spurred us into action,” he said. 

Eventually, Mr. Lunsford helped create the American Academy of Pediatrics’ recently released Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. 
 

Helping create change

According to Sandra Hassink, MD, coauthor of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, the goal was to “help patients make changes in lifestyle, behaviors, or environment in a sustainable way and also to involve families in decision-making at every step of the way.”

The guideline recommends comprehensive obesity treatment that may include nutritional support, exercise, behavioral therapy, medication, and metabolic and bariatric surgery.

Ideally, a child would receive intense behavioral and lifestyle treatment, although this approach isn’t always available and might be challenging to deliver. The most effective treatments include at least 26 hours of face-to-face, family-based treatments, consisting of many different components and lasting 3-12 months.

The guideline suggests that doctors offer adolescents 12 and older medication to assist in weight loss, along with health, behavior, and lifestyle treatment, and that teens who have severe obesity should consider metabolic and bariatric surgery as they continue intense health behavior and lifestyle treatment. 

“We’re living at a time where we’ve watched obesity affect our children and adult population for 4 decades and, along with the risk of obesity, we’ve watched a rise in obesity; we’re seeing increases in illness that go along with obesity, such as type 2 diabetes, lipid diseases like high cholesterol, and nonalcoholic fatty liver disease,” Dr. Hassink said.

She explained that, as people gain weight, the cells in adipose (fatty) tissues start to malfunction and produce inflammatory chemicals that cause these illnesses. 

“So having extra adipose tissue is a risk,” she said. “As pediatricians, we measure body mass index [BMI] – which is calculated based on height and weight – as a way of seeing whether the child could be at risk for developing these dysfunctioning cells. If so, we screen them for prediabetes, lipid disease, or liver disease and other obesity-related comorbidities.”

In addition, “we’re concerned about the mental health of children with obesity because of the weight bias in our culture,” said Dr. Hassink. “A child gets stigmatized, and this takes the form of bullying and teasing, and leads to low self-esteem, depression, and anxiety. So we know we have a host of physical problems we need to look out for, as well as the emotional and psychological effects of how our culture views things.”
 

Are parents ready for the new approach?

A new report from Harmony Healthcare IT, a data management firm that works with health data, looked at how parents regard their children’s obesity. The company surveyed more than 1,000 parents and found that one-tenth of respondents had children who were overweight or obese and over a quarter (26%) worried about their child’s weight.

Nearly 40% of parents would consider weight loss medication for their child if the child became obese at age 12, and about 16% would consider weight loss surgery. But most parents would not consider this surgery until their child was an average age of 15 rather than the AAP’s recommended age of 13.

Mr. Lunsford said that his son considered surgery and medication but was “never comfortable” with these approaches. 

This isn’t unusual, Dr. Hassink said. “Not every parent will think the same way, and their view will be based on their experience and what’s going on with their child.”

The guideline wasn’t designed to encourage every child to try medication or have surgery, she said. 

“But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician.”
 

Challenges to keeping healthy

It’s tough to stay healthy and not develop obesity in our modern environment, Dr. Hassink said. 

“There’s a lot of processed food, a lot of sugar in our foods, a lot of sedentary behavior, and a decrease in physical activity. In many communities, it’s hard for people to get healthy foods.”

Mr. Lunsford said that when his son was in his late teens and would go out with friends, they typically went to fast-food restaurants. 

“Sam would say ‘yes’ to these foods, although he knew they weren’t good for him, because he wanted to be like everyone else,” he said.

But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician, he said.

Harmony Health IT’s survey found that many parents say it is a struggle to get kids to eat healthy foods and get enough sleep. Although almost all respondents (83%) said they try to prepare healthy, home-cooked meals, 39% eat fast food at least once a week, mostly because parents are too tired to cook. 

Dr. Hassink said the COVID-19 pandemic also played a role.

“We knew that COVID would be hard for kids with obesity, and there might be weight gain because of the extra sedentary time and fewer sporting activities, and there was a high cost of food to families who are already economically strapped,” she said. 

In general, family support is essential, Dr. Hassink said. “Obesity treatment requires that the family be involved. The family is living in the same nutritional and activity environment as their child. Everyone has to be on board.”
 

Talking to kids about food and weight

The survey found that many parents struggle to talk about food and weight with their children. The AAP guideline notes that involving a health care professional can help. 

“If a parent or caregiver is concerned about a child’s weight, he or she can take the child to their pediatrician,” Dr. Hassink said. “The first thing the pediatrician will do is ask about the child’s overall health, review the family history – because obesity tends to run in families – and see if other conditions, like diabetes, also run in the family.” 

The pediatrician will do a physical examination that includes BMI and, if it’s high, other tests looking at blood sugar, lipids, and liver function may be performed. 

Ideally, the child will be prescribed intense lifestyle and behavioral treatment that will take the child’s and family’s nutrition into account, as well as physical activity and the amount of sleep the child is getting, which is sometimes tied to weight gain. If the child has disordered eating, such as binge eating disorder, they can be evaluated and treated for that.

Each child is seen as an individual with a particular set of needs. “One size doesn’t fit all,” Dr. Hassink said. 
 

Providing emotional support for children with obesity 

Pediatricians can assess the child’s mental, emotional, and social well-being. “Children who are bullied or teased may need help working through that. Children experiencing depression may need treatment,” Dr. Hassink said.

Mr. Lunsford said Samuel was fortunate in that he rarely got taunted. 

“Part of the reason is that, although weight was an issue, he never allowed his weight to define him,” he said. “He was always an extroverted kind of kid, athletic, very outgoing and friendly, and being overweight was never part of his identity.” 

Mr. Lunsford encourages parents whose children are teased or bullied to create a “no-judgment” zone at home. 

“Let your kids know that their parents love them for who they are,” he said. “Emphasize that weight is a ‘number’ and health is a ‘lifestyle.’ Try to highlight the good things in their lives and encourage them to be as active as they can in the things that interest them.”

A version of this article originally appeared on WebMD.com.

Douglas Lunsford’s son Samuel has struggled with obesity all his life.

Just before turning 14, Samuel, now 25, took part in a program at Ohio-based Nationwide Children’s Hospital’s Center for Healthy Weight and Nutrition. The program consisted of twice-weekly meetings with a nutritionist, including lessons in food portion size, what food does within the body, what foods can be used to supplement other foods, and similar topics, as well as physical exercise. 

Although the program was designed for youngsters with weight problems, Mr. Lunsford also took part. 

“They would exercise us and work us out,” he said.

Father and son did the program together for 2 years. Since then, Mr. Lunsford has advocated for youngsters with obesity. 

“Samuel’s struggle spurred us into action,” he said. 

Eventually, Mr. Lunsford helped create the American Academy of Pediatrics’ recently released Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. 
 

Helping create change

According to Sandra Hassink, MD, coauthor of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, the goal was to “help patients make changes in lifestyle, behaviors, or environment in a sustainable way and also to involve families in decision-making at every step of the way.”

The guideline recommends comprehensive obesity treatment that may include nutritional support, exercise, behavioral therapy, medication, and metabolic and bariatric surgery.

Ideally, a child would receive intense behavioral and lifestyle treatment, although this approach isn’t always available and might be challenging to deliver. The most effective treatments include at least 26 hours of face-to-face, family-based treatments, consisting of many different components and lasting 3-12 months.

The guideline suggests that doctors offer adolescents 12 and older medication to assist in weight loss, along with health, behavior, and lifestyle treatment, and that teens who have severe obesity should consider metabolic and bariatric surgery as they continue intense health behavior and lifestyle treatment. 

“We’re living at a time where we’ve watched obesity affect our children and adult population for 4 decades and, along with the risk of obesity, we’ve watched a rise in obesity; we’re seeing increases in illness that go along with obesity, such as type 2 diabetes, lipid diseases like high cholesterol, and nonalcoholic fatty liver disease,” Dr. Hassink said.

She explained that, as people gain weight, the cells in adipose (fatty) tissues start to malfunction and produce inflammatory chemicals that cause these illnesses. 

“So having extra adipose tissue is a risk,” she said. “As pediatricians, we measure body mass index [BMI] – which is calculated based on height and weight – as a way of seeing whether the child could be at risk for developing these dysfunctioning cells. If so, we screen them for prediabetes, lipid disease, or liver disease and other obesity-related comorbidities.”

In addition, “we’re concerned about the mental health of children with obesity because of the weight bias in our culture,” said Dr. Hassink. “A child gets stigmatized, and this takes the form of bullying and teasing, and leads to low self-esteem, depression, and anxiety. So we know we have a host of physical problems we need to look out for, as well as the emotional and psychological effects of how our culture views things.”
 

Are parents ready for the new approach?

A new report from Harmony Healthcare IT, a data management firm that works with health data, looked at how parents regard their children’s obesity. The company surveyed more than 1,000 parents and found that one-tenth of respondents had children who were overweight or obese and over a quarter (26%) worried about their child’s weight.

Nearly 40% of parents would consider weight loss medication for their child if the child became obese at age 12, and about 16% would consider weight loss surgery. But most parents would not consider this surgery until their child was an average age of 15 rather than the AAP’s recommended age of 13.

Mr. Lunsford said that his son considered surgery and medication but was “never comfortable” with these approaches. 

This isn’t unusual, Dr. Hassink said. “Not every parent will think the same way, and their view will be based on their experience and what’s going on with their child.”

The guideline wasn’t designed to encourage every child to try medication or have surgery, she said. 

“But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician.”
 

Challenges to keeping healthy

It’s tough to stay healthy and not develop obesity in our modern environment, Dr. Hassink said. 

“There’s a lot of processed food, a lot of sugar in our foods, a lot of sedentary behavior, and a decrease in physical activity. In many communities, it’s hard for people to get healthy foods.”

Mr. Lunsford said that when his son was in his late teens and would go out with friends, they typically went to fast-food restaurants. 

“Sam would say ‘yes’ to these foods, although he knew they weren’t good for him, because he wanted to be like everyone else,” he said.

But parents now know that there are potentially helpful choices here that we didn’t have years ago, and those can be discussed with the child’s pediatrician, he said.

Harmony Health IT’s survey found that many parents say it is a struggle to get kids to eat healthy foods and get enough sleep. Although almost all respondents (83%) said they try to prepare healthy, home-cooked meals, 39% eat fast food at least once a week, mostly because parents are too tired to cook. 

Dr. Hassink said the COVID-19 pandemic also played a role.

“We knew that COVID would be hard for kids with obesity, and there might be weight gain because of the extra sedentary time and fewer sporting activities, and there was a high cost of food to families who are already economically strapped,” she said. 

In general, family support is essential, Dr. Hassink said. “Obesity treatment requires that the family be involved. The family is living in the same nutritional and activity environment as their child. Everyone has to be on board.”
 

Talking to kids about food and weight

The survey found that many parents struggle to talk about food and weight with their children. The AAP guideline notes that involving a health care professional can help. 

“If a parent or caregiver is concerned about a child’s weight, he or she can take the child to their pediatrician,” Dr. Hassink said. “The first thing the pediatrician will do is ask about the child’s overall health, review the family history – because obesity tends to run in families – and see if other conditions, like diabetes, also run in the family.” 

The pediatrician will do a physical examination that includes BMI and, if it’s high, other tests looking at blood sugar, lipids, and liver function may be performed. 

Ideally, the child will be prescribed intense lifestyle and behavioral treatment that will take the child’s and family’s nutrition into account, as well as physical activity and the amount of sleep the child is getting, which is sometimes tied to weight gain. If the child has disordered eating, such as binge eating disorder, they can be evaluated and treated for that.

Each child is seen as an individual with a particular set of needs. “One size doesn’t fit all,” Dr. Hassink said. 
 

Providing emotional support for children with obesity 

Pediatricians can assess the child’s mental, emotional, and social well-being. “Children who are bullied or teased may need help working through that. Children experiencing depression may need treatment,” Dr. Hassink said.

Mr. Lunsford said Samuel was fortunate in that he rarely got taunted. 

“Part of the reason is that, although weight was an issue, he never allowed his weight to define him,” he said. “He was always an extroverted kind of kid, athletic, very outgoing and friendly, and being overweight was never part of his identity.” 

Mr. Lunsford encourages parents whose children are teased or bullied to create a “no-judgment” zone at home. 

“Let your kids know that their parents love them for who they are,” he said. “Emphasize that weight is a ‘number’ and health is a ‘lifestyle.’ Try to highlight the good things in their lives and encourage them to be as active as they can in the things that interest them.”

A version of this article originally appeared on WebMD.com.

This transcript has been edited for clarity.

Andrew N. Wilner, MD: I’m your host, Dr. Andrew Wilner, reporting virtually from the 2023 American Academy of Neurology meeting in Boston. It’s my pleasure today to speak with Dr. Shae Datta, codirector of the NYU Langone Concussion Center.

She’s also a clinical assistant professor of neurology at NYU School of Medicine. Dr. Datta is chair of the AAN Sports Neurology Section, and she’s leading a panel on concussion at this year’s meeting. She’s going to give us an update. Welcome, Dr. Datta.

Shae Datta, MD: Thank you so much, Andrew. I really love the fact that I’m here speaking to you about all of the new, exciting developments in the field.

Dr. Wilner: Before we get too deep, tell us how you got interested in this topic.

Dr. Datta: I initially thought, when I was in training as a resident, that I wanted to do something like neurocritical care or EEG. It also puzzled me why these seemingly smaller head injuries that didn’t end up in the hospital or ICU were bounced from neurology headache clinic to neuro-ophthalmology headache clinic to neurovestibular headache clinic, and nobody seemed to be able to put together the dots about why they’re having so many different issues — but at the same time, nobody could help them.

At that time, this field was very new. I was on a plane to Paris to a neurocritical care conference as a resident, and I saw the movie Concussion with Will Smith.

It featured one of my current mentors who taught at the fellowship that I graduated from, and it was a fascinating field. I just started looking deeply into it, and I saw that there was a new training fellowship for sports neurology and concussion management, and this is basically why we’re here today.
 

New concussion consensus guidelines coming

Dr. Wilner: I think this field has really exploded. It used to be that you banged your head, you did a CT scan – remember, I trained about 45 years ago – and if there was nothing on the CT scan, you were done. If you had headaches, you took Tylenol until they went away.

Now, we do MRI, and we realized that it’s really a syndrome. I understand that there are going to be some formal guidelines that have been put together. Is that correct?

Dr. Datta: That’s correct. The 6th International Consensus Conference on Concussion in Sport, in Amsterdam, where I attended and presented a poster, was really a meeting of all the best minds – clinicians and researchers in brain injury – to form a consensus on the newest guidelines that are going to direct our treatment going forward.

Dr. Wilner: I’m going to ask you a trick question because the last time I looked it up I did not get a satisfying answer. What is a concussion?

Dr. Datta: That’s a very good question, and everyone always asks. A concussion is an external force that is emitted upon the head or the neck, or the body, in general, that may cause temporary loss of function. It’s a functional problem.

We don’t see much on CT. We can do MRI. We can do SPECT or we can do these very fancy images, sometimes, of high-velocity head injuries and see small microhemorrhages.

Often, we don’t see anything, but still the patient is loopy. They can’t see straight. They are double-visioned. They have vertigo. Why is that happening? On the cellular level, we have an energy deficit in the sodium-potassium-ATPase pump of the neurons themselves.

Dr. Wilner: Suppose you do see diffuse axonal injury; does that take it out of concussion, or can you have a concussion with visible injury?

Dr. Datta: I think you can have overlap in the symptoms. The diffuse axonal injury would put it into a higher grade of head injury as opposed to a mild traumatic brain injury. Definitely, we would need to work together with our trauma doctors to ensure that patients are not on blood thinners or anything until they heal well enough. Obviously, I would pick them up as an outpatient and follow them until we resolve or rehab them as best as possible.

Concussion assessment tools

Dr. Wilner: There are many sports out there where concussions are fairly frequent, like American football and hockey, for example. Are there any statements in the new guidelines?

Dr. Datta: There are no statements for or against a particular sport because that would really make too much of a bold statement about cause and effect. There is a cause and effect in long-term, repetitive exposure, I would say, in terms of someone being able to play or sustain injury.

Right now, at least at the concussion conference I went to and in the upcoming consensus statement, they will not comment on a specific sport. Obviously, we know that the higher-impact sports are a little more dangerous.

Let’s be honest. At the high school, middle school, or even younger level, some kids are not necessarily the most athletic, right? They play because their friends are playing. If they’re repeatedly getting injured, it’s time for an astute clinician, or a coach, and a whole team to assess them to see if maybe this person is just going to continue to get hurt if they’re not taken out of the game and perhaps they should go to a lower-impact sport.

Dr. Wilner: In schools, often there’s a big size and weight difference. There are 14-year-olds who are 6 fett 2 inches and 200 pounds, and there are 14-year-olds who are 5 feet 2 inches and 110 pounds. Obviously, they’re mismatched on the football field.

You mentioned coaches. Is there anything in the guidelines about training coaches?

Dr. Datta: Specifically, there was nothing in the guidelines about that. There’s a tool for coaches at every level to use, which is called the Sports Concussion Assessment Tool, or SCAT, which is going to be updated to the SCAT6. At the NCAA level, they must receive annual training on concussion management and be given an NCAA concussion handout for coaches.

Obviously, there are more rigorous protocols for national-level coaching. As it stands now, it is not mandatory, but they are given tools to assess someone once they’ve gotten a hit to take them out of the game.

Dr. Wilner: I’ve been following the concussion research through the years. They did some neuropsychological testing on athletes who’ve had this many concussions or that many concussions, and they would find deficits here or subtle deficits there, but they had no baseline.

Then, there was a movement to start testing athletes before the season starts so that they could do a repeat test after concussion and see if there is any difference. Is that something we’re recommending?

Dr. Datta: Most of the time, NCAA-level – certainly where I trained – and national-level sports do testing, but it’s not everywhere. Prior guidelines have indicated that preseason testing is not required. That is largely because there has been no standardized neuropsychological testing established.

There are computerized testing options where the validity and reliability are questionable. Also, let’s say it’s a college student; they didn’t sleep all night and then they took this computer test. They would probably do worse than they would if they had received a head hit.

Just to be on the safe side, most places that have collegiate-level sports that are at a high level do preseason testing. If I were to speak personally, aside from the guidelines, I would say that it’s been helpful for me to look at the before and after, in general, overall, to make a decision about my treatment protocol.

Dr. Wilner: Let’s talk about the patient. You have a 20-year-old guy. He’s playing football. There’s a big play. Bonk, he gets hit on the head. He’s on the ground. He’s dazed, staggers a little bit, gets up, and you ask how he is feeling. He says he’s fine and then he wobbles off to the sideline. What do you do with that kid?

Dr. Datta: Obviously, the first thing is to remove him from the play environment to a quiet space. Second, either an athletic trainer or a coach would administer basic screening neurologic tests, such as “where are you, what’s today’s date, what is your name?” and other orientation questions.

They’ll also go through the SCAT – that’ll be SCAT6 starting in July – the SCAT5 symptom questionnaire to see what symptoms they have. Often, they’re using sideline testing software.

There are two things that can be used on a card to test eye movements, to see if they’re slower. They come out of NYU, coincidentally – the Memory Image Completion (MIC) and the Mobile Universal Lexicon Evaluation System (MULES) – and are used to determine whether eye movements are slower. That way, you can tell whether someone is, compared with before they got their head hit, slower than before.

Based on this composite information, usually the teammates and the head people on the team will know if a player looks different.

They need to be taken out, obviously, if there is nausea or vomiting, any neurologic signs and symptoms, or a neck injury that needs to be stabilized. ABCs first, right? If there’s any vomiting or seizures, they should be taken to the ER right away.

The first thing is to take them out, then do a sideline assessment. Third, see if they need to immediately go to the ED versus follow-up outpatient with me within a day or two.

Dr. Wilner: I think it’s the subtle injuries that are the tough ones. Back to our 20-year-old. He says: “Oh, I’m fine. I want to go back in the game.” Everybody can tell he’s not quite right, even though he passed all the tests. What do you do then?

Dr. Datta: You have to make a judgment call for the safety of the player. They always want to go back, right? This is also an issue when they’re competing for college scholarships and things of that nature. Sometimes they’re sandbagging, where they memorize the answers.

Everything’s on the Internet nowadays, right? We have to make a judgment call as members of the healthcare community and the sports community to keep that player safe.

Just keep them out. Don’t bring them back in the game. Keep them out for a reasonable amount of time. There’s a test called the Buffalo Concussion Treadmill Test; Dr. John Leddy from University of Buffalo has developed a way for us to put athletes through a screening protocol.

This can be part of their vestibular and ocular rehabilitation, where if they don’t have symptoms when we bring their heart rate to certain levels, then we can slowly clear them for return to play as long as they’re nonsymptomatic.

Dr. Wilner: I spoke with your colleague, Dr. Riggins, who is also on your panel, and we were talking about when they can go back. She said they can go back when they don’t have any symptoms. No more headache, no more dizziness, no more lightheadedness, no more trouble concentrating or with memory – all those things have gone away.

Sometimes these symptoms are stubborn. If you have, say, 100 patients like our 20-year-old who got bonked on the head, has some headaches, and doesn’t feel quite right, what usually happens? How many are back to play the next day, the next week, or the next month? How many are out for the season? How does that play out?

Dr. Datta: It depends on a couple of different factors. One, have they had previous head injuries? Two, do they have preexisting symptoms or signs, or diagnoses like migraines, which are likely to get worse after a head injury? Anything that’s preexisting, like a mood disorder, anxiety, depression, or trouble sleeping, is going to get worse.

If they were compensating for untreated ADD or borderline personality or bipolar, I’ve seen many people who’ve developed them. These are not the norm, but I’m saying that you have to be very careful.

Getting back to the question, you treat them. Reasonably, if they’re healthy and they don’t have preexisting signs and symptoms, I would say more than half are back in about 2 weeks.. I would say 60%-70%. It all depends. If they have preexisting issues, then it’s going to take much longer.
 

From SCAT to SCOAT

Dr. Wilner: This has been very informative. Before we wrap up, tell us what to expect from these guidelines in July. How are they really going to help?

Dr. Datta: The consensus statement is going to come out with something called a SCOAT, which stands for Sport Concussion Office Assessment Tool. We’ve been using the SCAT, which was meant for more sideline assessment because that’s all we had, and it’s worked perfectly well.

This will be better because we often see them within 24-48 hours, when the symptoms are sometimes a little bit better.

We also will see the sport and concussion group come up with added athlete perspectives, ethics discussion, power-sport athlete considerations, and development of this new SCOAT.

Dr. Wilner: Dr. Datta, this is very exciting. I look forward to reading these guidelines in July. I want to thank you for your hard work. I also look forward to talking to you at next year’s meeting. Thank you very much for giving us this update.

Dr. Datta: No problem. It’s my pleasure.

A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Andrew N. Wilner, MD: I’m your host, Dr. Andrew Wilner, reporting virtually from the 2023 American Academy of Neurology meeting in Boston. It’s my pleasure today to speak with Dr. Shae Datta, codirector of the NYU Langone Concussion Center.

She’s also a clinical assistant professor of neurology at NYU School of Medicine. Dr. Datta is chair of the AAN Sports Neurology Section, and she’s leading a panel on concussion at this year’s meeting. She’s going to give us an update. Welcome, Dr. Datta.

Shae Datta, MD: Thank you so much, Andrew. I really love the fact that I’m here speaking to you about all of the new, exciting developments in the field.

Dr. Wilner: Before we get too deep, tell us how you got interested in this topic.

Dr. Datta: I initially thought, when I was in training as a resident, that I wanted to do something like neurocritical care or EEG. It also puzzled me why these seemingly smaller head injuries that didn’t end up in the hospital or ICU were bounced from neurology headache clinic to neuro-ophthalmology headache clinic to neurovestibular headache clinic, and nobody seemed to be able to put together the dots about why they’re having so many different issues — but at the same time, nobody could help them.

At that time, this field was very new. I was on a plane to Paris to a neurocritical care conference as a resident, and I saw the movie Concussion with Will Smith.

It featured one of my current mentors who taught at the fellowship that I graduated from, and it was a fascinating field. I just started looking deeply into it, and I saw that there was a new training fellowship for sports neurology and concussion management, and this is basically why we’re here today.
 

New concussion consensus guidelines coming

Dr. Wilner: I think this field has really exploded. It used to be that you banged your head, you did a CT scan – remember, I trained about 45 years ago – and if there was nothing on the CT scan, you were done. If you had headaches, you took Tylenol until they went away.

Now, we do MRI, and we realized that it’s really a syndrome. I understand that there are going to be some formal guidelines that have been put together. Is that correct?

Dr. Datta: That’s correct. The 6th International Consensus Conference on Concussion in Sport, in Amsterdam, where I attended and presented a poster, was really a meeting of all the best minds – clinicians and researchers in brain injury – to form a consensus on the newest guidelines that are going to direct our treatment going forward.

Dr. Wilner: I’m going to ask you a trick question because the last time I looked it up I did not get a satisfying answer. What is a concussion?

Dr. Datta: That’s a very good question, and everyone always asks. A concussion is an external force that is emitted upon the head or the neck, or the body, in general, that may cause temporary loss of function. It’s a functional problem.

We don’t see much on CT. We can do MRI. We can do SPECT or we can do these very fancy images, sometimes, of high-velocity head injuries and see small microhemorrhages.

Often, we don’t see anything, but still the patient is loopy. They can’t see straight. They are double-visioned. They have vertigo. Why is that happening? On the cellular level, we have an energy deficit in the sodium-potassium-ATPase pump of the neurons themselves.

Dr. Wilner: Suppose you do see diffuse axonal injury; does that take it out of concussion, or can you have a concussion with visible injury?

Dr. Datta: I think you can have overlap in the symptoms. The diffuse axonal injury would put it into a higher grade of head injury as opposed to a mild traumatic brain injury. Definitely, we would need to work together with our trauma doctors to ensure that patients are not on blood thinners or anything until they heal well enough. Obviously, I would pick them up as an outpatient and follow them until we resolve or rehab them as best as possible.

Concussion assessment tools

Dr. Wilner: There are many sports out there where concussions are fairly frequent, like American football and hockey, for example. Are there any statements in the new guidelines?

Dr. Datta: There are no statements for or against a particular sport because that would really make too much of a bold statement about cause and effect. There is a cause and effect in long-term, repetitive exposure, I would say, in terms of someone being able to play or sustain injury.

Right now, at least at the concussion conference I went to and in the upcoming consensus statement, they will not comment on a specific sport. Obviously, we know that the higher-impact sports are a little more dangerous.

Let’s be honest. At the high school, middle school, or even younger level, some kids are not necessarily the most athletic, right? They play because their friends are playing. If they’re repeatedly getting injured, it’s time for an astute clinician, or a coach, and a whole team to assess them to see if maybe this person is just going to continue to get hurt if they’re not taken out of the game and perhaps they should go to a lower-impact sport.

Dr. Wilner: In schools, often there’s a big size and weight difference. There are 14-year-olds who are 6 fett 2 inches and 200 pounds, and there are 14-year-olds who are 5 feet 2 inches and 110 pounds. Obviously, they’re mismatched on the football field.

You mentioned coaches. Is there anything in the guidelines about training coaches?

Dr. Datta: Specifically, there was nothing in the guidelines about that. There’s a tool for coaches at every level to use, which is called the Sports Concussion Assessment Tool, or SCAT, which is going to be updated to the SCAT6. At the NCAA level, they must receive annual training on concussion management and be given an NCAA concussion handout for coaches.

Obviously, there are more rigorous protocols for national-level coaching. As it stands now, it is not mandatory, but they are given tools to assess someone once they’ve gotten a hit to take them out of the game.

Dr. Wilner: I’ve been following the concussion research through the years. They did some neuropsychological testing on athletes who’ve had this many concussions or that many concussions, and they would find deficits here or subtle deficits there, but they had no baseline.

Then, there was a movement to start testing athletes before the season starts so that they could do a repeat test after concussion and see if there is any difference. Is that something we’re recommending?

Dr. Datta: Most of the time, NCAA-level – certainly where I trained – and national-level sports do testing, but it’s not everywhere. Prior guidelines have indicated that preseason testing is not required. That is largely because there has been no standardized neuropsychological testing established.

There are computerized testing options where the validity and reliability are questionable. Also, let’s say it’s a college student; they didn’t sleep all night and then they took this computer test. They would probably do worse than they would if they had received a head hit.

Just to be on the safe side, most places that have collegiate-level sports that are at a high level do preseason testing. If I were to speak personally, aside from the guidelines, I would say that it’s been helpful for me to look at the before and after, in general, overall, to make a decision about my treatment protocol.

Dr. Wilner: Let’s talk about the patient. You have a 20-year-old guy. He’s playing football. There’s a big play. Bonk, he gets hit on the head. He’s on the ground. He’s dazed, staggers a little bit, gets up, and you ask how he is feeling. He says he’s fine and then he wobbles off to the sideline. What do you do with that kid?

Dr. Datta: Obviously, the first thing is to remove him from the play environment to a quiet space. Second, either an athletic trainer or a coach would administer basic screening neurologic tests, such as “where are you, what’s today’s date, what is your name?” and other orientation questions.

They’ll also go through the SCAT – that’ll be SCAT6 starting in July – the SCAT5 symptom questionnaire to see what symptoms they have. Often, they’re using sideline testing software.

There are two things that can be used on a card to test eye movements, to see if they’re slower. They come out of NYU, coincidentally – the Memory Image Completion (MIC) and the Mobile Universal Lexicon Evaluation System (MULES) – and are used to determine whether eye movements are slower. That way, you can tell whether someone is, compared with before they got their head hit, slower than before.

Based on this composite information, usually the teammates and the head people on the team will know if a player looks different.

They need to be taken out, obviously, if there is nausea or vomiting, any neurologic signs and symptoms, or a neck injury that needs to be stabilized. ABCs first, right? If there’s any vomiting or seizures, they should be taken to the ER right away.

The first thing is to take them out, then do a sideline assessment. Third, see if they need to immediately go to the ED versus follow-up outpatient with me within a day or two.

Dr. Wilner: I think it’s the subtle injuries that are the tough ones. Back to our 20-year-old. He says: “Oh, I’m fine. I want to go back in the game.” Everybody can tell he’s not quite right, even though he passed all the tests. What do you do then?

Dr. Datta: You have to make a judgment call for the safety of the player. They always want to go back, right? This is also an issue when they’re competing for college scholarships and things of that nature. Sometimes they’re sandbagging, where they memorize the answers.

Everything’s on the Internet nowadays, right? We have to make a judgment call as members of the healthcare community and the sports community to keep that player safe.

Just keep them out. Don’t bring them back in the game. Keep them out for a reasonable amount of time. There’s a test called the Buffalo Concussion Treadmill Test; Dr. John Leddy from University of Buffalo has developed a way for us to put athletes through a screening protocol.

This can be part of their vestibular and ocular rehabilitation, where if they don’t have symptoms when we bring their heart rate to certain levels, then we can slowly clear them for return to play as long as they’re nonsymptomatic.

Dr. Wilner: I spoke with your colleague, Dr. Riggins, who is also on your panel, and we were talking about when they can go back. She said they can go back when they don’t have any symptoms. No more headache, no more dizziness, no more lightheadedness, no more trouble concentrating or with memory – all those things have gone away.

Sometimes these symptoms are stubborn. If you have, say, 100 patients like our 20-year-old who got bonked on the head, has some headaches, and doesn’t feel quite right, what usually happens? How many are back to play the next day, the next week, or the next month? How many are out for the season? How does that play out?

Dr. Datta: It depends on a couple of different factors. One, have they had previous head injuries? Two, do they have preexisting symptoms or signs, or diagnoses like migraines, which are likely to get worse after a head injury? Anything that’s preexisting, like a mood disorder, anxiety, depression, or trouble sleeping, is going to get worse.

If they were compensating for untreated ADD or borderline personality or bipolar, I’ve seen many people who’ve developed them. These are not the norm, but I’m saying that you have to be very careful.

Getting back to the question, you treat them. Reasonably, if they’re healthy and they don’t have preexisting signs and symptoms, I would say more than half are back in about 2 weeks.. I would say 60%-70%. It all depends. If they have preexisting issues, then it’s going to take much longer.
 

From SCAT to SCOAT

Dr. Wilner: This has been very informative. Before we wrap up, tell us what to expect from these guidelines in July. How are they really going to help?

Dr. Datta: The consensus statement is going to come out with something called a SCOAT, which stands for Sport Concussion Office Assessment Tool. We’ve been using the SCAT, which was meant for more sideline assessment because that’s all we had, and it’s worked perfectly well.

This will be better because we often see them within 24-48 hours, when the symptoms are sometimes a little bit better.

We also will see the sport and concussion group come up with added athlete perspectives, ethics discussion, power-sport athlete considerations, and development of this new SCOAT.

Dr. Wilner: Dr. Datta, this is very exciting. I look forward to reading these guidelines in July. I want to thank you for your hard work. I also look forward to talking to you at next year’s meeting. Thank you very much for giving us this update.

Dr. Datta: No problem. It’s my pleasure.

A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Andrew N. Wilner, MD: I’m your host, Dr. Andrew Wilner, reporting virtually from the 2023 American Academy of Neurology meeting in Boston. It’s my pleasure today to speak with Dr. Shae Datta, codirector of the NYU Langone Concussion Center.

She’s also a clinical assistant professor of neurology at NYU School of Medicine. Dr. Datta is chair of the AAN Sports Neurology Section, and she’s leading a panel on concussion at this year’s meeting. She’s going to give us an update. Welcome, Dr. Datta.

Shae Datta, MD: Thank you so much, Andrew. I really love the fact that I’m here speaking to you about all of the new, exciting developments in the field.

Dr. Wilner: Before we get too deep, tell us how you got interested in this topic.

Dr. Datta: I initially thought, when I was in training as a resident, that I wanted to do something like neurocritical care or EEG. It also puzzled me why these seemingly smaller head injuries that didn’t end up in the hospital or ICU were bounced from neurology headache clinic to neuro-ophthalmology headache clinic to neurovestibular headache clinic, and nobody seemed to be able to put together the dots about why they’re having so many different issues — but at the same time, nobody could help them.

At that time, this field was very new. I was on a plane to Paris to a neurocritical care conference as a resident, and I saw the movie Concussion with Will Smith.

It featured one of my current mentors who taught at the fellowship that I graduated from, and it was a fascinating field. I just started looking deeply into it, and I saw that there was a new training fellowship for sports neurology and concussion management, and this is basically why we’re here today.
 

New concussion consensus guidelines coming

Dr. Wilner: I think this field has really exploded. It used to be that you banged your head, you did a CT scan – remember, I trained about 45 years ago – and if there was nothing on the CT scan, you were done. If you had headaches, you took Tylenol until they went away.

Now, we do MRI, and we realized that it’s really a syndrome. I understand that there are going to be some formal guidelines that have been put together. Is that correct?

Dr. Datta: That’s correct. The 6th International Consensus Conference on Concussion in Sport, in Amsterdam, where I attended and presented a poster, was really a meeting of all the best minds – clinicians and researchers in brain injury – to form a consensus on the newest guidelines that are going to direct our treatment going forward.

Dr. Wilner: I’m going to ask you a trick question because the last time I looked it up I did not get a satisfying answer. What is a concussion?

Dr. Datta: That’s a very good question, and everyone always asks. A concussion is an external force that is emitted upon the head or the neck, or the body, in general, that may cause temporary loss of function. It’s a functional problem.

We don’t see much on CT. We can do MRI. We can do SPECT or we can do these very fancy images, sometimes, of high-velocity head injuries and see small microhemorrhages.

Often, we don’t see anything, but still the patient is loopy. They can’t see straight. They are double-visioned. They have vertigo. Why is that happening? On the cellular level, we have an energy deficit in the sodium-potassium-ATPase pump of the neurons themselves.

Dr. Wilner: Suppose you do see diffuse axonal injury; does that take it out of concussion, or can you have a concussion with visible injury?

Dr. Datta: I think you can have overlap in the symptoms. The diffuse axonal injury would put it into a higher grade of head injury as opposed to a mild traumatic brain injury. Definitely, we would need to work together with our trauma doctors to ensure that patients are not on blood thinners or anything until they heal well enough. Obviously, I would pick them up as an outpatient and follow them until we resolve or rehab them as best as possible.

Concussion assessment tools

Dr. Wilner: There are many sports out there where concussions are fairly frequent, like American football and hockey, for example. Are there any statements in the new guidelines?

Dr. Datta: There are no statements for or against a particular sport because that would really make too much of a bold statement about cause and effect. There is a cause and effect in long-term, repetitive exposure, I would say, in terms of someone being able to play or sustain injury.

Right now, at least at the concussion conference I went to and in the upcoming consensus statement, they will not comment on a specific sport. Obviously, we know that the higher-impact sports are a little more dangerous.

Let’s be honest. At the high school, middle school, or even younger level, some kids are not necessarily the most athletic, right? They play because their friends are playing. If they’re repeatedly getting injured, it’s time for an astute clinician, or a coach, and a whole team to assess them to see if maybe this person is just going to continue to get hurt if they’re not taken out of the game and perhaps they should go to a lower-impact sport.

Dr. Wilner: In schools, often there’s a big size and weight difference. There are 14-year-olds who are 6 fett 2 inches and 200 pounds, and there are 14-year-olds who are 5 feet 2 inches and 110 pounds. Obviously, they’re mismatched on the football field.

You mentioned coaches. Is there anything in the guidelines about training coaches?

Dr. Datta: Specifically, there was nothing in the guidelines about that. There’s a tool for coaches at every level to use, which is called the Sports Concussion Assessment Tool, or SCAT, which is going to be updated to the SCAT6. At the NCAA level, they must receive annual training on concussion management and be given an NCAA concussion handout for coaches.

Obviously, there are more rigorous protocols for national-level coaching. As it stands now, it is not mandatory, but they are given tools to assess someone once they’ve gotten a hit to take them out of the game.

Dr. Wilner: I’ve been following the concussion research through the years. They did some neuropsychological testing on athletes who’ve had this many concussions or that many concussions, and they would find deficits here or subtle deficits there, but they had no baseline.

Then, there was a movement to start testing athletes before the season starts so that they could do a repeat test after concussion and see if there is any difference. Is that something we’re recommending?

Dr. Datta: Most of the time, NCAA-level – certainly where I trained – and national-level sports do testing, but it’s not everywhere. Prior guidelines have indicated that preseason testing is not required. That is largely because there has been no standardized neuropsychological testing established.

There are computerized testing options where the validity and reliability are questionable. Also, let’s say it’s a college student; they didn’t sleep all night and then they took this computer test. They would probably do worse than they would if they had received a head hit.

Just to be on the safe side, most places that have collegiate-level sports that are at a high level do preseason testing. If I were to speak personally, aside from the guidelines, I would say that it’s been helpful for me to look at the before and after, in general, overall, to make a decision about my treatment protocol.

Dr. Wilner: Let’s talk about the patient. You have a 20-year-old guy. He’s playing football. There’s a big play. Bonk, he gets hit on the head. He’s on the ground. He’s dazed, staggers a little bit, gets up, and you ask how he is feeling. He says he’s fine and then he wobbles off to the sideline. What do you do with that kid?

Dr. Datta: Obviously, the first thing is to remove him from the play environment to a quiet space. Second, either an athletic trainer or a coach would administer basic screening neurologic tests, such as “where are you, what’s today’s date, what is your name?” and other orientation questions.

They’ll also go through the SCAT – that’ll be SCAT6 starting in July – the SCAT5 symptom questionnaire to see what symptoms they have. Often, they’re using sideline testing software.

There are two things that can be used on a card to test eye movements, to see if they’re slower. They come out of NYU, coincidentally – the Memory Image Completion (MIC) and the Mobile Universal Lexicon Evaluation System (MULES) – and are used to determine whether eye movements are slower. That way, you can tell whether someone is, compared with before they got their head hit, slower than before.

Based on this composite information, usually the teammates and the head people on the team will know if a player looks different.

They need to be taken out, obviously, if there is nausea or vomiting, any neurologic signs and symptoms, or a neck injury that needs to be stabilized. ABCs first, right? If there’s any vomiting or seizures, they should be taken to the ER right away.

The first thing is to take them out, then do a sideline assessment. Third, see if they need to immediately go to the ED versus follow-up outpatient with me within a day or two.

Dr. Wilner: I think it’s the subtle injuries that are the tough ones. Back to our 20-year-old. He says: “Oh, I’m fine. I want to go back in the game.” Everybody can tell he’s not quite right, even though he passed all the tests. What do you do then?

Dr. Datta: You have to make a judgment call for the safety of the player. They always want to go back, right? This is also an issue when they’re competing for college scholarships and things of that nature. Sometimes they’re sandbagging, where they memorize the answers.

Everything’s on the Internet nowadays, right? We have to make a judgment call as members of the healthcare community and the sports community to keep that player safe.

Just keep them out. Don’t bring them back in the game. Keep them out for a reasonable amount of time. There’s a test called the Buffalo Concussion Treadmill Test; Dr. John Leddy from University of Buffalo has developed a way for us to put athletes through a screening protocol.

This can be part of their vestibular and ocular rehabilitation, where if they don’t have symptoms when we bring their heart rate to certain levels, then we can slowly clear them for return to play as long as they’re nonsymptomatic.

Dr. Wilner: I spoke with your colleague, Dr. Riggins, who is also on your panel, and we were talking about when they can go back. She said they can go back when they don’t have any symptoms. No more headache, no more dizziness, no more lightheadedness, no more trouble concentrating or with memory – all those things have gone away.

Sometimes these symptoms are stubborn. If you have, say, 100 patients like our 20-year-old who got bonked on the head, has some headaches, and doesn’t feel quite right, what usually happens? How many are back to play the next day, the next week, or the next month? How many are out for the season? How does that play out?

Dr. Datta: It depends on a couple of different factors. One, have they had previous head injuries? Two, do they have preexisting symptoms or signs, or diagnoses like migraines, which are likely to get worse after a head injury? Anything that’s preexisting, like a mood disorder, anxiety, depression, or trouble sleeping, is going to get worse.

If they were compensating for untreated ADD or borderline personality or bipolar, I’ve seen many people who’ve developed them. These are not the norm, but I’m saying that you have to be very careful.

Getting back to the question, you treat them. Reasonably, if they’re healthy and they don’t have preexisting signs and symptoms, I would say more than half are back in about 2 weeks.. I would say 60%-70%. It all depends. If they have preexisting issues, then it’s going to take much longer.
 

From SCAT to SCOAT

Dr. Wilner: This has been very informative. Before we wrap up, tell us what to expect from these guidelines in July. How are they really going to help?

Dr. Datta: The consensus statement is going to come out with something called a SCOAT, which stands for Sport Concussion Office Assessment Tool. We’ve been using the SCAT, which was meant for more sideline assessment because that’s all we had, and it’s worked perfectly well.

This will be better because we often see them within 24-48 hours, when the symptoms are sometimes a little bit better.

We also will see the sport and concussion group come up with added athlete perspectives, ethics discussion, power-sport athlete considerations, and development of this new SCOAT.

Dr. Wilner: Dr. Datta, this is very exciting. I look forward to reading these guidelines in July. I want to thank you for your hard work. I also look forward to talking to you at next year’s meeting. Thank you very much for giving us this update.

Dr. Datta: No problem. It’s my pleasure.

A version of this article originally appeared on Medscape.com.

The media is filled with stories about the opioid crisis. We have all heard the horror stories of addiction and overdose, as well as “pill mill” doctors. In fact, more than 932,000 people have died of drug overdose since 1999 and, in recent years, approximately 75% of drug overdoses involved opioids.

Yet, they still have their place in the treatment of pain. It has been estimated that approximately 37% of all opioid prescriptions are written by primary care doctors, so it is essential that we doctors know appropriate prescribing guidelines.

The CDC updated the 2016 guidelines for prescribing opioids for pain in 2022. They cover when to initiate prescribing of opioids, selecting appropriate opioids and doses, and deciding the duration of therapy. The guidelines do a great job providing evidence-based recommendations while at the same time keeping the problems with opioids in the picture.

For primary care doctors, pain is one of the most common complaints we see – from broken bones to low back pain to cancer pain. It is important to note that the current guidelines exclude pain from sickle cell disease, cancer-related pain, palliative care, and end-of-life care. The guidelines apply to acute, subacute, and chronic pain. Pain is a complex symptom and often needs a multipronged approach. We make a mistake if we just prescribe a pain medication without understanding the root cause of the pain.

The guidelines suggest starting with nonopioid medications and incorporating nonmedicinal modes of treatments, such as physical therapy, as well. Opioids should be started at the lowest dose and for the shortest duration. Immediate-release medications are preferred over long-acting or extended-release ones. The patient should always be informed of the risks and benefits.

While the guidelines do a great job recommending how to prescribe opioids, they do not go into any depth discussing other treatment options. Perhaps knowledge of other treatment modalities would help primary care physicians avoid opioid prescribing. When treating our patients, it is important to educate them on how to manage their own symptoms.

The guidelines also advise tapering patients who may have been on high-dose opioids for long periods of time. Doctors know this is a very difficult task. However, resources to help with this are often lacking. For example, rehab may not be covered under a patient’s insurance, or it may be cheaper to take an opioid than to go to physical therapy. Although the recommendation is to taper, community assets may not support this. Guidelines are one thing, but the rest of the health care system needs to catch up to them and make them practical.

Primary care doctors often utilize our physical medicine, rehabilitation, and pain management specialists to assist in managing our patients’ pain. Here too, access to this resource is often difficult to come by. Depending on a patient’s insurance, it can take months to get an appointment.

In general, the current guidelines offer 12 key recommendations when prescribing opioids. They are a great reference; however, we need more real-life tools. For many of us in primary care, these guidelines support what we’ve been doing all along.

Primary care doctors will surely play a huge role in addressing the opioid crisis. We can prescribe opioids appropriately, but it doesn’t erase the problems of those patients who were overprescribed in the past. Many still seek out these medications whether for monetary reasons or just for the high. It is often easy to blame the patient but the one in control is the one with the prescription pad. Yet, it is important to remember that many of these patients are in real pain and need help.

Often, it is simpler to just prescribe a pain medication than it is to explain why one is not appropriate. As primary care doctors, we need to be effective ambassadors of appropriate opioid prescribing and often that means doing the hard thing and saying no to a patient.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

fpnews@mdedge.com

The media is filled with stories about the opioid crisis. We have all heard the horror stories of addiction and overdose, as well as “pill mill” doctors. In fact, more than 932,000 people have died of drug overdose since 1999 and, in recent years, approximately 75% of drug overdoses involved opioids.

Yet, they still have their place in the treatment of pain. It has been estimated that approximately 37% of all opioid prescriptions are written by primary care doctors, so it is essential that we doctors know appropriate prescribing guidelines.

The CDC updated the 2016 guidelines for prescribing opioids for pain in 2022. They cover when to initiate prescribing of opioids, selecting appropriate opioids and doses, and deciding the duration of therapy. The guidelines do a great job providing evidence-based recommendations while at the same time keeping the problems with opioids in the picture.

For primary care doctors, pain is one of the most common complaints we see – from broken bones to low back pain to cancer pain. It is important to note that the current guidelines exclude pain from sickle cell disease, cancer-related pain, palliative care, and end-of-life care. The guidelines apply to acute, subacute, and chronic pain. Pain is a complex symptom and often needs a multipronged approach. We make a mistake if we just prescribe a pain medication without understanding the root cause of the pain.

The guidelines suggest starting with nonopioid medications and incorporating nonmedicinal modes of treatments, such as physical therapy, as well. Opioids should be started at the lowest dose and for the shortest duration. Immediate-release medications are preferred over long-acting or extended-release ones. The patient should always be informed of the risks and benefits.

While the guidelines do a great job recommending how to prescribe opioids, they do not go into any depth discussing other treatment options. Perhaps knowledge of other treatment modalities would help primary care physicians avoid opioid prescribing. When treating our patients, it is important to educate them on how to manage their own symptoms.

The guidelines also advise tapering patients who may have been on high-dose opioids for long periods of time. Doctors know this is a very difficult task. However, resources to help with this are often lacking. For example, rehab may not be covered under a patient’s insurance, or it may be cheaper to take an opioid than to go to physical therapy. Although the recommendation is to taper, community assets may not support this. Guidelines are one thing, but the rest of the health care system needs to catch up to them and make them practical.

Primary care doctors often utilize our physical medicine, rehabilitation, and pain management specialists to assist in managing our patients’ pain. Here too, access to this resource is often difficult to come by. Depending on a patient’s insurance, it can take months to get an appointment.

In general, the current guidelines offer 12 key recommendations when prescribing opioids. They are a great reference; however, we need more real-life tools. For many of us in primary care, these guidelines support what we’ve been doing all along.

Primary care doctors will surely play a huge role in addressing the opioid crisis. We can prescribe opioids appropriately, but it doesn’t erase the problems of those patients who were overprescribed in the past. Many still seek out these medications whether for monetary reasons or just for the high. It is often easy to blame the patient but the one in control is the one with the prescription pad. Yet, it is important to remember that many of these patients are in real pain and need help.

Often, it is simpler to just prescribe a pain medication than it is to explain why one is not appropriate. As primary care doctors, we need to be effective ambassadors of appropriate opioid prescribing and often that means doing the hard thing and saying no to a patient.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

fpnews@mdedge.com

The media is filled with stories about the opioid crisis. We have all heard the horror stories of addiction and overdose, as well as “pill mill” doctors. In fact, more than 932,000 people have died of drug overdose since 1999 and, in recent years, approximately 75% of drug overdoses involved opioids.

Yet, they still have their place in the treatment of pain. It has been estimated that approximately 37% of all opioid prescriptions are written by primary care doctors, so it is essential that we doctors know appropriate prescribing guidelines.

The CDC updated the 2016 guidelines for prescribing opioids for pain in 2022. They cover when to initiate prescribing of opioids, selecting appropriate opioids and doses, and deciding the duration of therapy. The guidelines do a great job providing evidence-based recommendations while at the same time keeping the problems with opioids in the picture.

For primary care doctors, pain is one of the most common complaints we see – from broken bones to low back pain to cancer pain. It is important to note that the current guidelines exclude pain from sickle cell disease, cancer-related pain, palliative care, and end-of-life care. The guidelines apply to acute, subacute, and chronic pain. Pain is a complex symptom and often needs a multipronged approach. We make a mistake if we just prescribe a pain medication without understanding the root cause of the pain.

The guidelines suggest starting with nonopioid medications and incorporating nonmedicinal modes of treatments, such as physical therapy, as well. Opioids should be started at the lowest dose and for the shortest duration. Immediate-release medications are preferred over long-acting or extended-release ones. The patient should always be informed of the risks and benefits.

While the guidelines do a great job recommending how to prescribe opioids, they do not go into any depth discussing other treatment options. Perhaps knowledge of other treatment modalities would help primary care physicians avoid opioid prescribing. When treating our patients, it is important to educate them on how to manage their own symptoms.

The guidelines also advise tapering patients who may have been on high-dose opioids for long periods of time. Doctors know this is a very difficult task. However, resources to help with this are often lacking. For example, rehab may not be covered under a patient’s insurance, or it may be cheaper to take an opioid than to go to physical therapy. Although the recommendation is to taper, community assets may not support this. Guidelines are one thing, but the rest of the health care system needs to catch up to them and make them practical.

Primary care doctors often utilize our physical medicine, rehabilitation, and pain management specialists to assist in managing our patients’ pain. Here too, access to this resource is often difficult to come by. Depending on a patient’s insurance, it can take months to get an appointment.

In general, the current guidelines offer 12 key recommendations when prescribing opioids. They are a great reference; however, we need more real-life tools. For many of us in primary care, these guidelines support what we’ve been doing all along.

Primary care doctors will surely play a huge role in addressing the opioid crisis. We can prescribe opioids appropriately, but it doesn’t erase the problems of those patients who were overprescribed in the past. Many still seek out these medications whether for monetary reasons or just for the high. It is often easy to blame the patient but the one in control is the one with the prescription pad. Yet, it is important to remember that many of these patients are in real pain and need help.

Often, it is simpler to just prescribe a pain medication than it is to explain why one is not appropriate. As primary care doctors, we need to be effective ambassadors of appropriate opioid prescribing and often that means doing the hard thing and saying no to a patient.

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

fpnews@mdedge.com