Rheumatology News

HUNTINGTON BEACH, CALIF. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

HUNTINGTON BEACH, CALIF. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

HUNTINGTON BEACH, CALIF. — The Food and Drug Administration (FDA) approvals of tapinarof 1% cream and roflumilast 0.3% cream as treatment options for patients with plaque psoriasis came more than 1 year after the American Academy of Dermatology/National Psoriasis Foundation Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures were published in 2021, leaving some clinicians to wonder how these two newcomer drugs fit into their clinical practice.

At the annual meeting of the Pacific Dermatologic Association, Jashin J. Wu, MD, one of the authors of the guidelines and a voluntary associate professor of dermatology at the University of Miami, Coral Gables, Florida, proposed that tapinarof 1% cream and roflumilast 0.3% cream be considered first-line treatments for mild psoriasis. “The reason is because they’re very fast-acting, effective,” and result in a large improvement over steroids, Dr. Wu said. “You don’t have to worry about steroid atrophy, and it eliminates the need to use many different agents for different parts of the body necessarily, such as a weaker steroid for the face and sensitive areas. It also eliminates the need for patients to switch out steroids, such as 2 weeks on and 2 weeks off.”

courtesy Doug Brunk

Tapinarof 1% cream (Vtama) was approved in May 2022, for the topical treatment of plaque psoriasis in adults, and is under FDA review for treating atopic dermatitis (AD). “It’s once a day application, which is nice,” Dr. Wu said. “It is a first-in-class topical aryl hydrocarbon receptor agonist that can be used for the intertriginous areas. That’s where I find it helpful.”

Roflumilast 0.3% cream (Zoryve), a phosphodiesterase-4 inhibitor, was approved in July 2022 for the treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older. It was subsequently approved for treating plaque psoriasis in patients 6 years and older. (Roflumilast 0.15% cream is approved for mild to moderate AD in people aged 6 years or older, and roflumilast 0.3% topical foam is approved for seborrheic dermatitis in adults and children 9 years of age and older.)

The drug is contraindicated for use in patients with certain liver problems. “Patients are not going to be eating tubes of this drug, so I wouldn’t worry about that too much, but be aware if the pharmacist raises a concern about this,” Dr. Wu said.

Dr. Wu disclosed that he is or has been a consultant, investigator, or speaker for AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Codex Labs, Dermavant, DermTech, Dr. Reddy’s Laboratories, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, Mindera, Novartis, Pfizer, Regeneron, Samsung Bioepis, Sanofi Genzyme, Solius, Sun Pharmaceuticals, UCB, and Zerigo Health.

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

TOPLINE:

The presence of an operational classification of drug interactions (ORCA) class 3 or 4 drug-drug interactions (DDIs) did not increase the risk for colchicine-related gastrointestinal adverse events or modify the effect of colchicine on death or hospitalization caused by COVID-19 infection in ambulatory patients.

METHODOLOGY:

• This secondary analysis of the COLCORONA trial aimed to evaluate if a potential DDI of colchicine was associated with changes in its pharmacokinetics or modified its clinical safety and efficacy in patients with COVID-19.
• Overall, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were randomly assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or a placebo (n = 2227).
• All the participants had at least one high-risk criterion such as age ≥ 70 years, diabetes, heart failure, systolic blood pressure ≥ 150 mm Hg, respiratory disease, coronary disease, body temperature ≥ 38.4 °C within the last 48 hours, dyspnea, bicytopenia, pancytopenia, or high neutrophil count with low lymphocyte count.
• The medications that could interact with colchicine were determined and categorized under ORCA classes 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (minimal risk).
• The primary outcome was any gastrointestinal adverse event assessed over a 30-day follow-up period.

TAKEAWAY:

• Among all the participants, 1% received medications with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most common interacting medications.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without and with a DDI, respectively, with the effect of colchicine being consistent regardless of the presence of drug interactions (P = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on combined risk for COVID-19 hospitalization or mortality (P = .80 for interaction).

IN PRACTICE:

“Once potential DDIs have been identified through screening, they must be tested,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, wrote in an invited commentary published online in JAMA Network Open. “Theoretical DDIs may not translate into real-world harms,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. It was published online in JAMA Network Open.

LIMITATIONS:

This study focused on the medications used by participants at baseline, which may not have captured all potential DDIs. The findings did not provide information on rare adverse events, such as rhabdomyolysis, which usually occur months after initiating drug therapy. Furthermore, all the study participants had confirmed SARS-CoV-2 infection, which may have increased their susceptibility to adverse reactions associated with the use of colchicine.

DISCLOSURES:

Some authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, American Heart Association, and other sources. The authors also declared serving on advisory boards or on the board of directors; receiving personal fees, grants, research support, or speaking fees; or having other ties with many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The presence of an operational classification of drug interactions (ORCA) class 3 or 4 drug-drug interactions (DDIs) did not increase the risk for colchicine-related gastrointestinal adverse events or modify the effect of colchicine on death or hospitalization caused by COVID-19 infection in ambulatory patients.

METHODOLOGY:

• This secondary analysis of the COLCORONA trial aimed to evaluate if a potential DDI of colchicine was associated with changes in its pharmacokinetics or modified its clinical safety and efficacy in patients with COVID-19.
• Overall, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were randomly assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or a placebo (n = 2227).
• All the participants had at least one high-risk criterion such as age ≥ 70 years, diabetes, heart failure, systolic blood pressure ≥ 150 mm Hg, respiratory disease, coronary disease, body temperature ≥ 38.4 °C within the last 48 hours, dyspnea, bicytopenia, pancytopenia, or high neutrophil count with low lymphocyte count.
• The medications that could interact with colchicine were determined and categorized under ORCA classes 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (minimal risk).
• The primary outcome was any gastrointestinal adverse event assessed over a 30-day follow-up period.

TAKEAWAY:

• Among all the participants, 1% received medications with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most common interacting medications.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without and with a DDI, respectively, with the effect of colchicine being consistent regardless of the presence of drug interactions (P = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on combined risk for COVID-19 hospitalization or mortality (P = .80 for interaction).

IN PRACTICE:

“Once potential DDIs have been identified through screening, they must be tested,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, wrote in an invited commentary published online in JAMA Network Open. “Theoretical DDIs may not translate into real-world harms,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. It was published online in JAMA Network Open.

LIMITATIONS:

This study focused on the medications used by participants at baseline, which may not have captured all potential DDIs. The findings did not provide information on rare adverse events, such as rhabdomyolysis, which usually occur months after initiating drug therapy. Furthermore, all the study participants had confirmed SARS-CoV-2 infection, which may have increased their susceptibility to adverse reactions associated with the use of colchicine.

DISCLOSURES:

Some authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, American Heart Association, and other sources. The authors also declared serving on advisory boards or on the board of directors; receiving personal fees, grants, research support, or speaking fees; or having other ties with many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

The presence of an operational classification of drug interactions (ORCA) class 3 or 4 drug-drug interactions (DDIs) did not increase the risk for colchicine-related gastrointestinal adverse events or modify the effect of colchicine on death or hospitalization caused by COVID-19 infection in ambulatory patients.

METHODOLOGY:

• This secondary analysis of the COLCORONA trial aimed to evaluate if a potential DDI of colchicine was associated with changes in its pharmacokinetics or modified its clinical safety and efficacy in patients with COVID-19.
• Overall, 4432 ambulatory patients with COVID-19 (median age, 54 years; 54% women) were randomly assigned to receive colchicine 0.5 mg twice daily for 3 days and then 0.5 mg once daily for 27 days (n = 2205) or a placebo (n = 2227).
• All the participants had at least one high-risk criterion such as age ≥ 70 years, diabetes, heart failure, systolic blood pressure ≥ 150 mm Hg, respiratory disease, coronary disease, body temperature ≥ 38.4 °C within the last 48 hours, dyspnea, bicytopenia, pancytopenia, or high neutrophil count with low lymphocyte count.
• The medications that could interact with colchicine were determined and categorized under ORCA classes 1 (contraindicated), 2 (provisionally contraindicated), 3 (conditional use), or 4 (minimal risk).
• The primary outcome was any gastrointestinal adverse event assessed over a 30-day follow-up period.

TAKEAWAY:

• Among all the participants, 1% received medications with an ORCA class 2 interaction, 14% with a class 3 interaction, and 13% with a class 4 interaction; rosuvastatin (12%) and atorvastatin (10%) were the most common interacting medications.
• The odds of any gastrointestinal adverse event were 1.80 times and 1.68 times higher in the colchicine arm than in the placebo arm among those without and with a DDI, respectively, with the effect of colchicine being consistent regardless of the presence of drug interactions (P = .69 for interaction).
• Similarly, DDIs did not influence the effect of colchicine on combined risk for COVID-19 hospitalization or mortality (P = .80 for interaction).

IN PRACTICE:

“Once potential DDIs have been identified through screening, they must be tested,” Hemalkumar B. Mehta, PhD, and G. Caleb Alexander, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, wrote in an invited commentary published online in JAMA Network Open. “Theoretical DDIs may not translate into real-world harms,” they added.

SOURCE:

The study was led by Lama S. Alfehaid, PharmD, of Brigham and Women’s Hospital, Boston. It was published online in JAMA Network Open.

LIMITATIONS:

This study focused on the medications used by participants at baseline, which may not have captured all potential DDIs. The findings did not provide information on rare adverse events, such as rhabdomyolysis, which usually occur months after initiating drug therapy. Furthermore, all the study participants had confirmed SARS-CoV-2 infection, which may have increased their susceptibility to adverse reactions associated with the use of colchicine.

DISCLOSURES:

Some authors were supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute, American Heart Association, and other sources. The authors also declared serving on advisory boards or on the board of directors; receiving personal fees, grants, research support, or speaking fees; or having other ties with many pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

• Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
• Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
• In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

• Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
• Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
• The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
• Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

• Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
• Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
• This spike at higher temperatures is presumably due to air conditioning, the authors said.
• In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

• Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
• Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
• In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

• Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
• Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
• The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
• Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

• Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
• Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
• This spike at higher temperatures is presumably due to air conditioning, the authors said.
• In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In systemic sclerosis, Raynaud phenomenon is more severe at both high and low temperature extremes, according to new research.

BACKGROUND:

• Raynaud phenomenon, a condition that causes decreased blood flow to extremities, occurs in about 95% of individuals with systemic sclerosis.
• Episodes of Raynaud phenomenon can be triggered by cold exposure and ambient temperature changes.
• In severe cases, it can cause permanent damage to tissues of the fingers and toes.

METHODOLOGY:

• Researchers analyzed data from 2243 participants with Raynaud phenomenon secondary to systemic sclerosis from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort.
• Participants completed past-week Raynaud phenomenon severity assessments using a 0-10 numerical rating scale at enrollment and every 3 months.
• The study included data from 20,233 Raynaud phenomenon severity assessments between April 15, 2014, and August 1, 2023.
• Researchers used average daily temperature from a weather site close to the participant’s recruiting center and mapped these ambient temperature changes to Raynaud’s phenomenon outcomes.

TAKEAWAY:

• Raynaud’s phenomenon severity was highest at –25 °C (–13 °F), with assessment scores at 6.8 points out of 10.0, and lowest at 25 °C (77 °F), with scores at 2.6.
• Severity scores increased again at temperatures above 35 °C (95 °F), reaching a high of 5.6 out of 10 at 40 °C (104 °F).
• This spike at higher temperatures is presumably due to air conditioning, the authors said.
• In an accompanying commentary, Cutolo et al. posited that increased sweating and hypotension could also lead to a relative hypovolemic state in patients, causing Raynaud-like symptoms.

IN PRACTICE:

“Temperature-related variations in Raynaud’s phenomenon severity scores should be considered in clinical trials to account for normal within-season temperature fluctuations, enhancing the accuracy of treatment outcomes,” wrote Cutolo and colleagues in their commentary.

SOURCE:

The study was led by Gabrielle Virgili-Gervais, MSc, McGill University Health Centre in Montreal, Quebec, Canada. It was published online on August 28 in The Lancet Rheumatology. The accompanying commentary, also published on August 28, was authored by Maurizio Cutolo, MD, and Elvis Hysa, MD, both of University of Genova, Italy, as well as Vanessa Smith, MD, PhD, of Ghent University in Ghent, Belgium.

LIMITATIONS:

The lower number of assessments at extreme temperatures (–25 °C and 40 °C) may affect the robustness of the findings at these ranges. The study did not account for vasodilator use, which could influence participants’ response to temperature. The study also did not account for other potential confounding factors such as sex, smoking status, psychosocial factors, and comorbid conditions like cardiovascular disease.

DISCLOSURES:

A variety of scleroderma-related patient advocacy groups helped to fund research on the SPIN cohort, in addition to the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University. Two authors reported having financial ties with pharmaceutical companies. Dr. Cutolo, Dr. Smith, and Dr. Hysa had no disclosures.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Middle-aged adults who consume more ultra-processed foods have an elevated risk for rheumatoid arthritis (RA) that is mediated in part through circulating biomarkers.

METHODOLOGY: 

• Investigators conducted a retrospective cohort study of 207,012 middle-aged adults without RA from the UK Biobank who completed 24-hour dietary recalls.
• Foods and beverages were classified as (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, or (4) ultra-processed foods (eg, soft drinks, sweet or savory packaged snacks, reconstituted meat products, pre-prepared frozen dishes).
• The main outcome was the incident RA based on hospital diagnoses.

TAKEAWAY:

• Overall, 0.9% of participants received an RA diagnosis during a median follow-up of about 12 years.
• Relative to peers in the lowest quintile of ultra-processed food consumption, participants in the highest quintile had a 17% greater adjusted risk for RA.
• The risk rose across quintile (P < .05) and increased by 6% with each standard deviation increase in ultra-processed food intake.
• Mediation analyses suggested that inflammatory, lipid, and liver enzyme biomarkers explained 3.1%-14.8% of the association between ultra-processed food intake and RA risk.
• Findings were similar regardless of participants’ age, sex, body mass index, smoking status, household income, and healthy diet score.

IN PRACTICE: 

“Lower [ultra-processed food] consumption is recommended to reduce RA incidence,” the authors wrote, noting that up to half of the food consumed in the United Kingdom now falls into the ultra-processed category. “Dietary guidelines should prominently feature the detrimental effects of [ultra-processed foods], and recommendations to curtail their consumption should be integrated into public health initiatives, to mitigate the risk of RA,” they added.

SOURCE:

The study was led by Haodong Zhao, Soochow University, Suzhou, China, and was published online in The American Journal of Clinical Nutrition. 

LIMITATIONS:

Limitations included possible recall and social desirability biases, potential residual confounding, and uncertain causality of the observed associations.

DISCLOSURES:

The study was funded by grants from the National Natural Science Foundation of China and other institutions. The authors reported no conflicts of interest.

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

TOPLINE:

Middle-aged adults who consume more ultra-processed foods have an elevated risk for rheumatoid arthritis (RA) that is mediated in part through circulating biomarkers.

METHODOLOGY: 

• Investigators conducted a retrospective cohort study of 207,012 middle-aged adults without RA from the UK Biobank who completed 24-hour dietary recalls.
• Foods and beverages were classified as (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, or (4) ultra-processed foods (eg, soft drinks, sweet or savory packaged snacks, reconstituted meat products, pre-prepared frozen dishes).
• The main outcome was the incident RA based on hospital diagnoses.

TAKEAWAY:

• Overall, 0.9% of participants received an RA diagnosis during a median follow-up of about 12 years.
• Relative to peers in the lowest quintile of ultra-processed food consumption, participants in the highest quintile had a 17% greater adjusted risk for RA.
• The risk rose across quintile (P < .05) and increased by 6% with each standard deviation increase in ultra-processed food intake.
• Mediation analyses suggested that inflammatory, lipid, and liver enzyme biomarkers explained 3.1%-14.8% of the association between ultra-processed food intake and RA risk.
• Findings were similar regardless of participants’ age, sex, body mass index, smoking status, household income, and healthy diet score.

IN PRACTICE: 

“Lower [ultra-processed food] consumption is recommended to reduce RA incidence,” the authors wrote, noting that up to half of the food consumed in the United Kingdom now falls into the ultra-processed category. “Dietary guidelines should prominently feature the detrimental effects of [ultra-processed foods], and recommendations to curtail their consumption should be integrated into public health initiatives, to mitigate the risk of RA,” they added.

SOURCE:

The study was led by Haodong Zhao, Soochow University, Suzhou, China, and was published online in The American Journal of Clinical Nutrition. 

LIMITATIONS:

Limitations included possible recall and social desirability biases, potential residual confounding, and uncertain causality of the observed associations.

DISCLOSURES:

The study was funded by grants from the National Natural Science Foundation of China and other institutions. The authors reported no conflicts of interest.

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

TOPLINE:

Middle-aged adults who consume more ultra-processed foods have an elevated risk for rheumatoid arthritis (RA) that is mediated in part through circulating biomarkers.

METHODOLOGY: 

• Investigators conducted a retrospective cohort study of 207,012 middle-aged adults without RA from the UK Biobank who completed 24-hour dietary recalls.
• Foods and beverages were classified as (1) unprocessed or minimally processed foods, (2) processed culinary ingredients, (3) processed foods, or (4) ultra-processed foods (eg, soft drinks, sweet or savory packaged snacks, reconstituted meat products, pre-prepared frozen dishes).
• The main outcome was the incident RA based on hospital diagnoses.

TAKEAWAY:

• Overall, 0.9% of participants received an RA diagnosis during a median follow-up of about 12 years.
• Relative to peers in the lowest quintile of ultra-processed food consumption, participants in the highest quintile had a 17% greater adjusted risk for RA.
• The risk rose across quintile (P < .05) and increased by 6% with each standard deviation increase in ultra-processed food intake.
• Mediation analyses suggested that inflammatory, lipid, and liver enzyme biomarkers explained 3.1%-14.8% of the association between ultra-processed food intake and RA risk.
• Findings were similar regardless of participants’ age, sex, body mass index, smoking status, household income, and healthy diet score.

IN PRACTICE: 

“Lower [ultra-processed food] consumption is recommended to reduce RA incidence,” the authors wrote, noting that up to half of the food consumed in the United Kingdom now falls into the ultra-processed category. “Dietary guidelines should prominently feature the detrimental effects of [ultra-processed foods], and recommendations to curtail their consumption should be integrated into public health initiatives, to mitigate the risk of RA,” they added.

SOURCE:

The study was led by Haodong Zhao, Soochow University, Suzhou, China, and was published online in The American Journal of Clinical Nutrition. 

LIMITATIONS:

Limitations included possible recall and social desirability biases, potential residual confounding, and uncertain causality of the observed associations.

DISCLOSURES:

The study was funded by grants from the National Natural Science Foundation of China and other institutions. The authors reported no conflicts of interest.

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

A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states.

Mercer’s projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages.

“The labor market is a little more stabilized right now, and most healthcare systems are seeing less turnover,” Dan Lezotte, PhD, a partner with Mercer, said in an interview. But he noted “critical shortages” are still expected in some areas.

Mercer last projected workforce numbers in a 2020-2021 report released during the height of the COVID-19 pandemic. Now, “the labor market is drastically different,” Dr. Lezotte said. Health workforce shortages and surpluses have long varied significantly by region across the country.

The report forecasts a small surplus of physicians in 2028 but not in states such as California, New York, and Texas. The upper Midwest states will largely see doctor surpluses while Southern states face shortages. Some states with general physician surpluses may still experience shortages of specialists.

A surplus of nearly 30,000 registered nurses is expected, but New York, New Jersey, and Connecticut are projected to have a combined shortage of 16,000 nurses.

Overall, the report projects a shortage of more than 100,000 healthcare workers nationally by 2028. That’s less than 1% of the entire healthcare workforce of 18.6 million expected by then.

The report also predicts a shortage of nurse practitioners, especially in California and New York, and a shortage of 73,000 nursing assistants, especially in California, New York, and Texas.

“Healthcare systems are having the most difficulty hiring and hanging on to those workers who are supposed to take up the load off physicians and nurses,” Dr. Lezotte said. “They’re competing not only with other healthcare systems but with other industries like Amazon warehouses or McDonald’s in California paying $20 an hour. Healthcare was a little slow to keep up with that. In a lot of healthcare systems, that’s their biggest headache right now.”

On the other hand, the report projects a national surplus of 48,000 home health/personal care aides.

That surprised Bianca K. Frogner, PhD, director of the Center for Health Workforce Studies at the University of Washington, Seattle.

“We are seeing increasing movement of investments toward moving patients out of skilled nursing facilities and keeping them in the home and community, which requires many more home health aides,” Dr. Frogner said. “Given such high turnover in this occupation, it’s hard to know if the surplus is really a surplus or if they will quickly be employed.”

Dr. Frogner receives grants and contracts from not-for-profit entities to investigate issues related to the health workforce.

Dr. Lezotte said the report’s findings are based on data from sources such as public and private databases and job postings. According to the report, “projections were made up to 2028 based on historical data up to 2023,” and “supply projections were derived using a linear autoregressive model based on historical supply within each occupation and geography.”

It’s not clear why some states like New York are expected to have huge shortages, but migration might be a factor, along with a lack of nearby nursing schools, Dr. Lezotte said.

As for shortages, Dr. Lezotte said healthcare systems will have to understand their local workforce situation and adapt. “They’ll need to be more proactive about their employee value proposition” via competitive pay and benefits Flexibility regarding scheduling is also important.

“They’re going to have to figure out how to up their game,” he said.

What about states with surpluses? They might be target-rich environments for states facing shortages, he said.
 

Positive Outlook Not Shared by Other Researchers

Other workforce projections conflict with Mercer’s, according to Jean Moore, DrPH, and Gaetano Forte, MS, director and assistant director of the Center for Health Workforce Studies, School of Public Health, University at Albany, New York.

The National Center for Health Workforce Analysis projects a 10% shortage of registered nurses and a 13% shortage of physicians in 2031. The agency didn’t make projections for home health aides because that workforce is in flux.

Why are Mercer’s projections so different? Dr. Lezotte said other projections assume that equity efforts will bring healthcare to everyone who needs it. The report assumes this won’t happen, he said. As a result, it expects there will be fewer patients who need to be served by workers.

Other projections expect a shortage of 300,000 registered nurses by 2035, Mr. Forte said. But the number of nurse practitioners in New York is growing quickly, Dr. Moore said.

Dr. Moore said it’s difficult to interpret Mercer’s findings because the company doesn’t provide enough information about its methodology.

“At some level, it’s not particularly useful regarding what the next steps are,” she said. “Projections should make you think about what you should do to change and improve, to create more of what you need.”

The Center for Health Workforce Studies at the University of Albany has provided consulting services to multiple companies that provide healthcare workforce projections. It has no relationship with Mercer.

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

A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states.

Mercer’s projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages.

“The labor market is a little more stabilized right now, and most healthcare systems are seeing less turnover,” Dan Lezotte, PhD, a partner with Mercer, said in an interview. But he noted “critical shortages” are still expected in some areas.

Mercer last projected workforce numbers in a 2020-2021 report released during the height of the COVID-19 pandemic. Now, “the labor market is drastically different,” Dr. Lezotte said. Health workforce shortages and surpluses have long varied significantly by region across the country.

The report forecasts a small surplus of physicians in 2028 but not in states such as California, New York, and Texas. The upper Midwest states will largely see doctor surpluses while Southern states face shortages. Some states with general physician surpluses may still experience shortages of specialists.

A surplus of nearly 30,000 registered nurses is expected, but New York, New Jersey, and Connecticut are projected to have a combined shortage of 16,000 nurses.

Overall, the report projects a shortage of more than 100,000 healthcare workers nationally by 2028. That’s less than 1% of the entire healthcare workforce of 18.6 million expected by then.

The report also predicts a shortage of nurse practitioners, especially in California and New York, and a shortage of 73,000 nursing assistants, especially in California, New York, and Texas.

“Healthcare systems are having the most difficulty hiring and hanging on to those workers who are supposed to take up the load off physicians and nurses,” Dr. Lezotte said. “They’re competing not only with other healthcare systems but with other industries like Amazon warehouses or McDonald’s in California paying $20 an hour. Healthcare was a little slow to keep up with that. In a lot of healthcare systems, that’s their biggest headache right now.”

On the other hand, the report projects a national surplus of 48,000 home health/personal care aides.

That surprised Bianca K. Frogner, PhD, director of the Center for Health Workforce Studies at the University of Washington, Seattle.

“We are seeing increasing movement of investments toward moving patients out of skilled nursing facilities and keeping them in the home and community, which requires many more home health aides,” Dr. Frogner said. “Given such high turnover in this occupation, it’s hard to know if the surplus is really a surplus or if they will quickly be employed.”

Dr. Frogner receives grants and contracts from not-for-profit entities to investigate issues related to the health workforce.

Dr. Lezotte said the report’s findings are based on data from sources such as public and private databases and job postings. According to the report, “projections were made up to 2028 based on historical data up to 2023,” and “supply projections were derived using a linear autoregressive model based on historical supply within each occupation and geography.”

It’s not clear why some states like New York are expected to have huge shortages, but migration might be a factor, along with a lack of nearby nursing schools, Dr. Lezotte said.

As for shortages, Dr. Lezotte said healthcare systems will have to understand their local workforce situation and adapt. “They’ll need to be more proactive about their employee value proposition” via competitive pay and benefits Flexibility regarding scheduling is also important.

“They’re going to have to figure out how to up their game,” he said.

What about states with surpluses? They might be target-rich environments for states facing shortages, he said.
 

Positive Outlook Not Shared by Other Researchers

Other workforce projections conflict with Mercer’s, according to Jean Moore, DrPH, and Gaetano Forte, MS, director and assistant director of the Center for Health Workforce Studies, School of Public Health, University at Albany, New York.

The National Center for Health Workforce Analysis projects a 10% shortage of registered nurses and a 13% shortage of physicians in 2031. The agency didn’t make projections for home health aides because that workforce is in flux.

Why are Mercer’s projections so different? Dr. Lezotte said other projections assume that equity efforts will bring healthcare to everyone who needs it. The report assumes this won’t happen, he said. As a result, it expects there will be fewer patients who need to be served by workers.

Other projections expect a shortage of 300,000 registered nurses by 2035, Mr. Forte said. But the number of nurse practitioners in New York is growing quickly, Dr. Moore said.

Dr. Moore said it’s difficult to interpret Mercer’s findings because the company doesn’t provide enough information about its methodology.

“At some level, it’s not particularly useful regarding what the next steps are,” she said. “Projections should make you think about what you should do to change and improve, to create more of what you need.”

The Center for Health Workforce Studies at the University of Albany has provided consulting services to multiple companies that provide healthcare workforce projections. It has no relationship with Mercer.

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

A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states.

Mercer’s projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages.

“The labor market is a little more stabilized right now, and most healthcare systems are seeing less turnover,” Dan Lezotte, PhD, a partner with Mercer, said in an interview. But he noted “critical shortages” are still expected in some areas.

Mercer last projected workforce numbers in a 2020-2021 report released during the height of the COVID-19 pandemic. Now, “the labor market is drastically different,” Dr. Lezotte said. Health workforce shortages and surpluses have long varied significantly by region across the country.

The report forecasts a small surplus of physicians in 2028 but not in states such as California, New York, and Texas. The upper Midwest states will largely see doctor surpluses while Southern states face shortages. Some states with general physician surpluses may still experience shortages of specialists.

A surplus of nearly 30,000 registered nurses is expected, but New York, New Jersey, and Connecticut are projected to have a combined shortage of 16,000 nurses.

Overall, the report projects a shortage of more than 100,000 healthcare workers nationally by 2028. That’s less than 1% of the entire healthcare workforce of 18.6 million expected by then.

The report also predicts a shortage of nurse practitioners, especially in California and New York, and a shortage of 73,000 nursing assistants, especially in California, New York, and Texas.

“Healthcare systems are having the most difficulty hiring and hanging on to those workers who are supposed to take up the load off physicians and nurses,” Dr. Lezotte said. “They’re competing not only with other healthcare systems but with other industries like Amazon warehouses or McDonald’s in California paying $20 an hour. Healthcare was a little slow to keep up with that. In a lot of healthcare systems, that’s their biggest headache right now.”

On the other hand, the report projects a national surplus of 48,000 home health/personal care aides.

That surprised Bianca K. Frogner, PhD, director of the Center for Health Workforce Studies at the University of Washington, Seattle.

“We are seeing increasing movement of investments toward moving patients out of skilled nursing facilities and keeping them in the home and community, which requires many more home health aides,” Dr. Frogner said. “Given such high turnover in this occupation, it’s hard to know if the surplus is really a surplus or if they will quickly be employed.”

Dr. Frogner receives grants and contracts from not-for-profit entities to investigate issues related to the health workforce.

Dr. Lezotte said the report’s findings are based on data from sources such as public and private databases and job postings. According to the report, “projections were made up to 2028 based on historical data up to 2023,” and “supply projections were derived using a linear autoregressive model based on historical supply within each occupation and geography.”

It’s not clear why some states like New York are expected to have huge shortages, but migration might be a factor, along with a lack of nearby nursing schools, Dr. Lezotte said.

As for shortages, Dr. Lezotte said healthcare systems will have to understand their local workforce situation and adapt. “They’ll need to be more proactive about their employee value proposition” via competitive pay and benefits Flexibility regarding scheduling is also important.

“They’re going to have to figure out how to up their game,” he said.

What about states with surpluses? They might be target-rich environments for states facing shortages, he said.
 

Positive Outlook Not Shared by Other Researchers

Other workforce projections conflict with Mercer’s, according to Jean Moore, DrPH, and Gaetano Forte, MS, director and assistant director of the Center for Health Workforce Studies, School of Public Health, University at Albany, New York.

The National Center for Health Workforce Analysis projects a 10% shortage of registered nurses and a 13% shortage of physicians in 2031. The agency didn’t make projections for home health aides because that workforce is in flux.

Why are Mercer’s projections so different? Dr. Lezotte said other projections assume that equity efforts will bring healthcare to everyone who needs it. The report assumes this won’t happen, he said. As a result, it expects there will be fewer patients who need to be served by workers.

Other projections expect a shortage of 300,000 registered nurses by 2035, Mr. Forte said. But the number of nurse practitioners in New York is growing quickly, Dr. Moore said.

Dr. Moore said it’s difficult to interpret Mercer’s findings because the company doesn’t provide enough information about its methodology.

“At some level, it’s not particularly useful regarding what the next steps are,” she said. “Projections should make you think about what you should do to change and improve, to create more of what you need.”

The Center for Health Workforce Studies at the University of Albany has provided consulting services to multiple companies that provide healthcare workforce projections. It has no relationship with Mercer.

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

Hematologists and rheumatologists may be able to adopt a more aggressive approach for managing low-grade marginal lymphoma in Sjögren disease, particularly mucosa-associated lymphoid tissue (MALT) lymphoma, based on recent findings that confirmed a key early biomarker and found that a systemic treatment strategy reduced Sjögren disease activity and the risk for lymphoma relapse.

Two European studies published in The Lancet Rheumatology — one a case-control study reporting that rheumatoid factor (RF) was an early and strong predictor of Sjögren disease–related MALT lymphoma and the other a retrospective study that found a combination of chemotherapy and anti-CD20 therapy with rituximab as a first-line treatment for lymphoma was more effective than localized treatment or watch-and-wait approach in minimizing autoimmune activity and treating the lymphoma — potentially shed new light on strategies to manage Sjögren disease–related lymphoma.

A commentary accompanying the studies noted that 5%-10% of patients with Sjögren disease will develop non-Hodgkin B-cell lymphoma, with marginal lymphoma the most common type of low-grade lymphoma. The commentary, led by Suzanne Arends, MD, a rheumatologist at the University of Groningen in Groningen, the Netherlands, found the studies “clinically relevant” but stated that the lack of consistent definitions between the two studies along with their retrospective nature prevent any “definitive conclusions.”
 

High Lymphoma Risk in Sjögren Disease

“It is the autoimmune disease in which the risk of lymphoma is the highest, a 10- to 20-fold increase of the risk of lymphoma in this disease,” Xavier Mariette, MD, PhD, co-senior author of the retrospective treatment study, said of Sjögren disease.

These lymphomas are predominantly the marginal zone type, specifically MALT occurring in the salivary glands, the same site of the autoimmune disease, said Dr. Mariette, who is the head of Rheumatology and professor at Université Paris-Saclay and Hôpital Bicêtre. Autoimmune B cells become lymphomatous. “So there is a continuity between autoimmunity and lymphoma genesis,” Dr. Mariette told this news organization. Typically, hematologists do not treat the lymphoma if it doesn’t migrate beyond the salivary glands, he said.

RF Biomarker

The case-control study by researchers in Italy and Greece included 80 patients with Sjögren-related MALT lymphoma matched to controls with Sjögren disease who did not have lymphoma.

“We showed that rheumatoid factor positivity at the time of Sjögren’s disease diagnosis serves as the most reliable and temporally distant independent predictor of MALT lymphoma development,” lead author Andreas Goules, MD, a pathophysiologist at the National and Kapodistrian University of Athens, Athens, Greece, told this news organization.

What Future Studies Should Look At

The studies call for further research into biomarkers for Sjögren disease–related lymphoma and treatment of the disease, both Dr. Mariette and Dr. Goules said.

Dr. Goules said a multicenter prospective study is needed to measure RF positivity and RF titers over time and determine whether higher levels mean an increased risk for lymphoma development or a shorter time interval until lymphoma onset. “Such a study requires a large number of RF-positive Sjögren’s disease patients who would be followed up for a long period of time,” Dr. Goules said.

To further evaluate treatment approaches for Sjögren disease–related lymphoma, Dr. Mariette said, a prospective study should compare the watch-and-wait approach with combination chemotherapy and anti-CD20 therapy. “It would be difficult to run because the primary endpoint would be lymphoma progression–free survival, and the secondary would be Sjögren’s relapse and mortality, but it would take a lot of time,” he said.

He added, “It’s a reason why this retrospective study is important. Maybe if we had another retrospective study reaching the same conclusion, I think it would be very, very strong evidence.”

Funding for the case-control study came from the European Commission–Horizon 2020 program. The retrospective treatment study had no outside funding. Dr. Mariette disclosed financial relationships with AstraZeneca, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Novartis, and Pfizer. Dr. Alderuccio, Dr. Goules, and Dr. Baer had no relevant relationships to disclose.

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

Hematologists and rheumatologists may be able to adopt a more aggressive approach for managing low-grade marginal lymphoma in Sjögren disease, particularly mucosa-associated lymphoid tissue (MALT) lymphoma, based on recent findings that confirmed a key early biomarker and found that a systemic treatment strategy reduced Sjögren disease activity and the risk for lymphoma relapse.

Two European studies published in The Lancet Rheumatology — one a case-control study reporting that rheumatoid factor (RF) was an early and strong predictor of Sjögren disease–related MALT lymphoma and the other a retrospective study that found a combination of chemotherapy and anti-CD20 therapy with rituximab as a first-line treatment for lymphoma was more effective than localized treatment or watch-and-wait approach in minimizing autoimmune activity and treating the lymphoma — potentially shed new light on strategies to manage Sjögren disease–related lymphoma.

A commentary accompanying the studies noted that 5%-10% of patients with Sjögren disease will develop non-Hodgkin B-cell lymphoma, with marginal lymphoma the most common type of low-grade lymphoma. The commentary, led by Suzanne Arends, MD, a rheumatologist at the University of Groningen in Groningen, the Netherlands, found the studies “clinically relevant” but stated that the lack of consistent definitions between the two studies along with their retrospective nature prevent any “definitive conclusions.”
 

High Lymphoma Risk in Sjögren Disease

“It is the autoimmune disease in which the risk of lymphoma is the highest, a 10- to 20-fold increase of the risk of lymphoma in this disease,” Xavier Mariette, MD, PhD, co-senior author of the retrospective treatment study, said of Sjögren disease.

These lymphomas are predominantly the marginal zone type, specifically MALT occurring in the salivary glands, the same site of the autoimmune disease, said Dr. Mariette, who is the head of Rheumatology and professor at Université Paris-Saclay and Hôpital Bicêtre. Autoimmune B cells become lymphomatous. “So there is a continuity between autoimmunity and lymphoma genesis,” Dr. Mariette told this news organization. Typically, hematologists do not treat the lymphoma if it doesn’t migrate beyond the salivary glands, he said.

RF Biomarker

The case-control study by researchers in Italy and Greece included 80 patients with Sjögren-related MALT lymphoma matched to controls with Sjögren disease who did not have lymphoma.

“We showed that rheumatoid factor positivity at the time of Sjögren’s disease diagnosis serves as the most reliable and temporally distant independent predictor of MALT lymphoma development,” lead author Andreas Goules, MD, a pathophysiologist at the National and Kapodistrian University of Athens, Athens, Greece, told this news organization.

What Future Studies Should Look At

The studies call for further research into biomarkers for Sjögren disease–related lymphoma and treatment of the disease, both Dr. Mariette and Dr. Goules said.

Dr. Goules said a multicenter prospective study is needed to measure RF positivity and RF titers over time and determine whether higher levels mean an increased risk for lymphoma development or a shorter time interval until lymphoma onset. “Such a study requires a large number of RF-positive Sjögren’s disease patients who would be followed up for a long period of time,” Dr. Goules said.

To further evaluate treatment approaches for Sjögren disease–related lymphoma, Dr. Mariette said, a prospective study should compare the watch-and-wait approach with combination chemotherapy and anti-CD20 therapy. “It would be difficult to run because the primary endpoint would be lymphoma progression–free survival, and the secondary would be Sjögren’s relapse and mortality, but it would take a lot of time,” he said.

He added, “It’s a reason why this retrospective study is important. Maybe if we had another retrospective study reaching the same conclusion, I think it would be very, very strong evidence.”

Funding for the case-control study came from the European Commission–Horizon 2020 program. The retrospective treatment study had no outside funding. Dr. Mariette disclosed financial relationships with AstraZeneca, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Novartis, and Pfizer. Dr. Alderuccio, Dr. Goules, and Dr. Baer had no relevant relationships to disclose.

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

Hematologists and rheumatologists may be able to adopt a more aggressive approach for managing low-grade marginal lymphoma in Sjögren disease, particularly mucosa-associated lymphoid tissue (MALT) lymphoma, based on recent findings that confirmed a key early biomarker and found that a systemic treatment strategy reduced Sjögren disease activity and the risk for lymphoma relapse.

Two European studies published in The Lancet Rheumatology — one a case-control study reporting that rheumatoid factor (RF) was an early and strong predictor of Sjögren disease–related MALT lymphoma and the other a retrospective study that found a combination of chemotherapy and anti-CD20 therapy with rituximab as a first-line treatment for lymphoma was more effective than localized treatment or watch-and-wait approach in minimizing autoimmune activity and treating the lymphoma — potentially shed new light on strategies to manage Sjögren disease–related lymphoma.

A commentary accompanying the studies noted that 5%-10% of patients with Sjögren disease will develop non-Hodgkin B-cell lymphoma, with marginal lymphoma the most common type of low-grade lymphoma. The commentary, led by Suzanne Arends, MD, a rheumatologist at the University of Groningen in Groningen, the Netherlands, found the studies “clinically relevant” but stated that the lack of consistent definitions between the two studies along with their retrospective nature prevent any “definitive conclusions.”
 

High Lymphoma Risk in Sjögren Disease

“It is the autoimmune disease in which the risk of lymphoma is the highest, a 10- to 20-fold increase of the risk of lymphoma in this disease,” Xavier Mariette, MD, PhD, co-senior author of the retrospective treatment study, said of Sjögren disease.

These lymphomas are predominantly the marginal zone type, specifically MALT occurring in the salivary glands, the same site of the autoimmune disease, said Dr. Mariette, who is the head of Rheumatology and professor at Université Paris-Saclay and Hôpital Bicêtre. Autoimmune B cells become lymphomatous. “So there is a continuity between autoimmunity and lymphoma genesis,” Dr. Mariette told this news organization. Typically, hematologists do not treat the lymphoma if it doesn’t migrate beyond the salivary glands, he said.

RF Biomarker

The case-control study by researchers in Italy and Greece included 80 patients with Sjögren-related MALT lymphoma matched to controls with Sjögren disease who did not have lymphoma.

“We showed that rheumatoid factor positivity at the time of Sjögren’s disease diagnosis serves as the most reliable and temporally distant independent predictor of MALT lymphoma development,” lead author Andreas Goules, MD, a pathophysiologist at the National and Kapodistrian University of Athens, Athens, Greece, told this news organization.

What Future Studies Should Look At

The studies call for further research into biomarkers for Sjögren disease–related lymphoma and treatment of the disease, both Dr. Mariette and Dr. Goules said.

Dr. Goules said a multicenter prospective study is needed to measure RF positivity and RF titers over time and determine whether higher levels mean an increased risk for lymphoma development or a shorter time interval until lymphoma onset. “Such a study requires a large number of RF-positive Sjögren’s disease patients who would be followed up for a long period of time,” Dr. Goules said.

To further evaluate treatment approaches for Sjögren disease–related lymphoma, Dr. Mariette said, a prospective study should compare the watch-and-wait approach with combination chemotherapy and anti-CD20 therapy. “It would be difficult to run because the primary endpoint would be lymphoma progression–free survival, and the secondary would be Sjögren’s relapse and mortality, but it would take a lot of time,” he said.

He added, “It’s a reason why this retrospective study is important. Maybe if we had another retrospective study reaching the same conclusion, I think it would be very, very strong evidence.”

Funding for the case-control study came from the European Commission–Horizon 2020 program. The retrospective treatment study had no outside funding. Dr. Mariette disclosed financial relationships with AstraZeneca, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Novartis, and Pfizer. Dr. Alderuccio, Dr. Goules, and Dr. Baer had no relevant relationships to disclose.

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

TOPLINE:

Higher rheumatoid arthritis (RA) disease activity is associated with an accelerated kidney function decline and increased risk for chronic kidney disease (CKD) stages G3a and G3b.

METHODOLOGY:

• Researchers analyzed data from the CorEvitas RA registry, a prospective observational cohort in the United States, between 2001 and 2022, to evaluate the longitudinal association between RA disease activity and changes in kidney function.
• They included 31,129 patients with RA (median age, 58 years; 76.3% women) who had a baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m² and received treatment with disease-modifying antirheumatic drugs (DMARDs).
• The participants were categorized into those in remission (n = 6647) and those with low (n = 10,028), moderate (n = 8548), and high (n = 5906) disease activity based on the time-averaged Clinical Disease Activity Index and followed for a median duration of 3.5 years.
• The primary outcome was a longitudinal change in eGFR, and the secondary outcomes were the development of CKD stage G3a (eGFR < 60 mL/min/1.73 m2) and stage G3b (eGFR < 45 mL/min/1.73 m2).

TAKEAWAY:

• Higher RA disease activity was associated with a faster decline in eGFR, with those having moderate and high RA disease activity experiencing an additional mean annual decline of 0.17 mL/min per 1.73 m² and 0.18 mL/min per 1.73 m², respectively, compared with those in remission.
• The decline in annual eGFR was even more accelerated when patients had consistently high disease activity since the time of enrollment (−0.43 mL/min per 1.73 m²).
• Patients with high RA disease activity had a 1.27 times (adjusted hazard ratio, 1.27; 95% CI, 1.05-1.52) higher risk of developing CKD stage G3a and a 1.93 times (aHR, 1.93; 95% CI, 1.16-3.20) higher risk for CKD stage G3b, compared with those in remission.

IN PRACTICE:

“This study suggests that controlling disease activity may potentially contribute to preserving kidney function in patients with RA,” the authors wrote.

SOURCE:

This study was led by Sho Fukui, MD, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, Massachusetts, and was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

This study relied on serum creatinine and not cystatin C to estimate kidney function. It also did not collect information on the severity of comorbidities, which may have introduced residual confounding. Further studies are warranted to check the effect of DMARD therapy on renal function.

DISCLOSURES:

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported serving as scientific advisers or consultants, receiving consulting fees or salary support, or having other ties with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Higher rheumatoid arthritis (RA) disease activity is associated with an accelerated kidney function decline and increased risk for chronic kidney disease (CKD) stages G3a and G3b.

METHODOLOGY:

• Researchers analyzed data from the CorEvitas RA registry, a prospective observational cohort in the United States, between 2001 and 2022, to evaluate the longitudinal association between RA disease activity and changes in kidney function.
• They included 31,129 patients with RA (median age, 58 years; 76.3% women) who had a baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m² and received treatment with disease-modifying antirheumatic drugs (DMARDs).
• The participants were categorized into those in remission (n = 6647) and those with low (n = 10,028), moderate (n = 8548), and high (n = 5906) disease activity based on the time-averaged Clinical Disease Activity Index and followed for a median duration of 3.5 years.
• The primary outcome was a longitudinal change in eGFR, and the secondary outcomes were the development of CKD stage G3a (eGFR < 60 mL/min/1.73 m2) and stage G3b (eGFR < 45 mL/min/1.73 m2).

TAKEAWAY:

• Higher RA disease activity was associated with a faster decline in eGFR, with those having moderate and high RA disease activity experiencing an additional mean annual decline of 0.17 mL/min per 1.73 m² and 0.18 mL/min per 1.73 m², respectively, compared with those in remission.
• The decline in annual eGFR was even more accelerated when patients had consistently high disease activity since the time of enrollment (−0.43 mL/min per 1.73 m²).
• Patients with high RA disease activity had a 1.27 times (adjusted hazard ratio, 1.27; 95% CI, 1.05-1.52) higher risk of developing CKD stage G3a and a 1.93 times (aHR, 1.93; 95% CI, 1.16-3.20) higher risk for CKD stage G3b, compared with those in remission.

IN PRACTICE:

“This study suggests that controlling disease activity may potentially contribute to preserving kidney function in patients with RA,” the authors wrote.

SOURCE:

This study was led by Sho Fukui, MD, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, Massachusetts, and was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

This study relied on serum creatinine and not cystatin C to estimate kidney function. It also did not collect information on the severity of comorbidities, which may have introduced residual confounding. Further studies are warranted to check the effect of DMARD therapy on renal function.

DISCLOSURES:

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported serving as scientific advisers or consultants, receiving consulting fees or salary support, or having other ties with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Higher rheumatoid arthritis (RA) disease activity is associated with an accelerated kidney function decline and increased risk for chronic kidney disease (CKD) stages G3a and G3b.

METHODOLOGY:

• Researchers analyzed data from the CorEvitas RA registry, a prospective observational cohort in the United States, between 2001 and 2022, to evaluate the longitudinal association between RA disease activity and changes in kidney function.
• They included 31,129 patients with RA (median age, 58 years; 76.3% women) who had a baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min per 1.73 m² and received treatment with disease-modifying antirheumatic drugs (DMARDs).
• The participants were categorized into those in remission (n = 6647) and those with low (n = 10,028), moderate (n = 8548), and high (n = 5906) disease activity based on the time-averaged Clinical Disease Activity Index and followed for a median duration of 3.5 years.
• The primary outcome was a longitudinal change in eGFR, and the secondary outcomes were the development of CKD stage G3a (eGFR < 60 mL/min/1.73 m2) and stage G3b (eGFR < 45 mL/min/1.73 m2).

TAKEAWAY:

• Higher RA disease activity was associated with a faster decline in eGFR, with those having moderate and high RA disease activity experiencing an additional mean annual decline of 0.17 mL/min per 1.73 m² and 0.18 mL/min per 1.73 m², respectively, compared with those in remission.
• The decline in annual eGFR was even more accelerated when patients had consistently high disease activity since the time of enrollment (−0.43 mL/min per 1.73 m²).
• Patients with high RA disease activity had a 1.27 times (adjusted hazard ratio, 1.27; 95% CI, 1.05-1.52) higher risk of developing CKD stage G3a and a 1.93 times (aHR, 1.93; 95% CI, 1.16-3.20) higher risk for CKD stage G3b, compared with those in remission.

IN PRACTICE:

“This study suggests that controlling disease activity may potentially contribute to preserving kidney function in patients with RA,” the authors wrote.

SOURCE:

This study was led by Sho Fukui, MD, Division of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital and Harvard Medical School, both in Boston, Massachusetts, and was published online in Annals of the Rheumatic Diseases.

LIMITATIONS:

This study relied on serum creatinine and not cystatin C to estimate kidney function. It also did not collect information on the severity of comorbidities, which may have introduced residual confounding. Further studies are warranted to check the effect of DMARD therapy on renal function.

DISCLOSURES:

The study was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some authors reported serving as scientific advisers or consultants, receiving consulting fees or salary support, or having other ties with pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

• Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
• They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
• They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
• The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
• The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

• At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
• Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
• Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

• Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
• They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
• They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
• The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
• The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

• At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
• Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
• Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Patients with both rheumatoid arthritis (RA) and atrial fibrillation (AF) have a higher risk for ischemic stroke than those with only AF. They are also less likely to receive oral anticoagulant treatment, which may contribute to this increased stroke risk.

METHODOLOGY:

• Researchers conducted a registry-based retrospective cohort study using the Norwegian Cardio-Rheuma Register to evaluate the risk for ischemic stroke following the diagnosis of AF in patients with or without RA.
• They included 163,595 patients with newly diagnosed AF between 2010 and 2017, of whom 2750 had RA. Patients had to be diagnosed with RA before the diagnosis of AF.
• They also assessed whether patients with RA were less likely to receive oral anticoagulants for stroke prevention within 3 months of AF diagnosis than those without RA.
• The median follow-up time was 2.5 years for patients with RA and 3.0 years for those without RA.
• The primary endpoint was ischemic stroke, which was identified through hospital admissions and visits.

TAKEAWAY:

• At 5 years, patients with both RA and AF showed a higher cumulative incidence of ischemic stroke than those with only AF (7.3% vs 5.0%).
• Among patients with AF, the risk of having a stroke was 25% higher in those with RA than in those without RA (adjusted hazard ratio, 1.25; 95% CI, 1.05-1.50).
• Patients with RA were also less likely to receive treatment with oral anticoagulants than those without RA, driven by concerns over potential interactions with RA medications, bleeding risk, or other factors (adjusted odds ratio, 0.88; 95% CI, 0.80-0.97). 

IN PRACTICE:

“Our study prompts preventive measures such as meticulous cardiovascular risk factor control among patients with RA and AF and raises the question whether the presence of RA should be taken into account when considering OAC [oral anticoagulant] treatment for AF patients,” the authors wrote.

SOURCE:

This study was led by Anne M. Kerola, MD, PhD, Helsinki University Hospital and University of Helsinki in Finland. It was published online in Rheumatology.

LIMITATIONS: 

This study lacked data on smoking, blood pressure measurements, alcohol use, and obesity, which may have affected the comprehensiveness of the findings. The study population was limited to Norway and may not be generalizable to other populations.

DISCLOSURES:

This study was supported by the Olav Thon Foundation, the Research Council of Norway, and the Foundation for Research in Rheumatology. Some authors received speaker fees, participated in advisory boards, served as consultants, or had other ties with some pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Teclistamab, a T-cell engager that targets B-cell maturation antigen (BCMA), improved disease activity in four patients with refractory autoimmune conditions. In a separately published case report, teclistamab treatment induced remission in a patient with refractory systemic lupus erythematosus (SLE).

BACKGROUND: 

• Chimeric antigen receptor (CAR) T cells or T-cell engagers against CD19 have been effective in small studies of patients with treatment-resistant autoimmune diseases.
• Some patients have disease rooted in long-lived plasma cells that express BCMA but not CD19, making them resistant to CD19 CAR T-cell therapy.
• Teclistamab acts on T cells through CD3 and targets plasmablasts and plasma cells through BCMA.

METHODOLOGY:

• In one case series, researchers administered teclistamab subcutaneously to four patients with autoimmune diseases resistant to more than five immunosuppressants, including rituximab.
• Patient 1 had systemic sclerosis, patient 2 had primary Sjögren disease, patient 3 had idiopathic inflammatory myositis, and patient 4 had rheumatoid arthritis.
• Researchers incrementally increased teclistamab dosage in an inpatient setting: 0.06 mg/kg on day 1, 0.3 mg/kg on day 3, and 1.5 mg/kg on day 5. Patients 2, 3, and 4 received one maintenance dose of 1.5 mg/kg after 4 weeks, and patient 1 received a 1.5-mg/kg dose after 12 weeks.
• In the single case report, the patient with SLE received a step-up dosage of teclistamab (0.06 mg/kg and 0.3 mg/kg) followed by 0.8 mg/kg on day 7. She received 1.5 mg/kg at weeks 2 and 5.

TAKEAWAY: 

• Teclistamab therapy led to significant improvements in disease activity in all four patients, with notable reductions in skin disease, arthritis, and lung function scores.
• Teclistamab therapy had a good safety profile, with no neurotoxicity or myelotoxicity and only lower-grade cytokine release syndrome reported.
• Researchers observed seroconversion of PM-Scl-75, PM-Scl-100, rheumatoid factor, and autoantibodies against mutated citrullinated vimentin and lower levels of autoantibodies ANA, MDAS, SS-A/Ro, SS-B/La, and PL-7 after treatment.
• In the separate case report, the patient reached complete drug-free remission by week 6, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000.
• The level of anti–double-stranded DNA antibodies in the patient with SLE decreased rapidly, reaching normal range by week 5 and remaining undetectable through week 16.

IN PRACTICE:

“These data show that the targeting of the plasma-cell compartment by a BCMA-targeted T-cell engager is feasible in patients with autoimmune disease. Whether such therapy results in sustained clinical remission warrants further study,” write the authors of the four-patient case series.

SOURCE: 

Melanie Hagen, MD, Friedrich Alexander University Erlangen–Nuremberg, Germany, and colleagues reported their case series online in The New England Journal of Medicine. Tobias Alexander, MD, and colleagues at Charité–Universitätsmedizin Berlin, Germany, also described their single case report in The New England Journal of Medicine.

LIMITATIONS:

The small number of patients limits the generalizability of the findings. The short duration of follow-up may not capture long-term effects and potential late-onset adverse events. The lack of a control group makes it difficult to attribute improvements solely to teclistamab therapy.

DISCLOSURES:

The four-patient case series was supported by grants from the Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the European Union. The single case report was supported by grants from the Deutsche Forschungsgemeinschaft and the European Union. Several authors have disclosed financial relationships with pharmaceutical companies, including Janssen Biotech, which markets teclistamab.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Teclistamab, a T-cell engager that targets B-cell maturation antigen (BCMA), improved disease activity in four patients with refractory autoimmune conditions. In a separately published case report, teclistamab treatment induced remission in a patient with refractory systemic lupus erythematosus (SLE).

BACKGROUND: 

• Chimeric antigen receptor (CAR) T cells or T-cell engagers against CD19 have been effective in small studies of patients with treatment-resistant autoimmune diseases.
• Some patients have disease rooted in long-lived plasma cells that express BCMA but not CD19, making them resistant to CD19 CAR T-cell therapy.
• Teclistamab acts on T cells through CD3 and targets plasmablasts and plasma cells through BCMA.

METHODOLOGY:

• In one case series, researchers administered teclistamab subcutaneously to four patients with autoimmune diseases resistant to more than five immunosuppressants, including rituximab.
• Patient 1 had systemic sclerosis, patient 2 had primary Sjögren disease, patient 3 had idiopathic inflammatory myositis, and patient 4 had rheumatoid arthritis.
• Researchers incrementally increased teclistamab dosage in an inpatient setting: 0.06 mg/kg on day 1, 0.3 mg/kg on day 3, and 1.5 mg/kg on day 5. Patients 2, 3, and 4 received one maintenance dose of 1.5 mg/kg after 4 weeks, and patient 1 received a 1.5-mg/kg dose after 12 weeks.
• In the single case report, the patient with SLE received a step-up dosage of teclistamab (0.06 mg/kg and 0.3 mg/kg) followed by 0.8 mg/kg on day 7. She received 1.5 mg/kg at weeks 2 and 5.

TAKEAWAY: 

• Teclistamab therapy led to significant improvements in disease activity in all four patients, with notable reductions in skin disease, arthritis, and lung function scores.
• Teclistamab therapy had a good safety profile, with no neurotoxicity or myelotoxicity and only lower-grade cytokine release syndrome reported.
• Researchers observed seroconversion of PM-Scl-75, PM-Scl-100, rheumatoid factor, and autoantibodies against mutated citrullinated vimentin and lower levels of autoantibodies ANA, MDAS, SS-A/Ro, SS-B/La, and PL-7 after treatment.
• In the separate case report, the patient reached complete drug-free remission by week 6, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000.
• The level of anti–double-stranded DNA antibodies in the patient with SLE decreased rapidly, reaching normal range by week 5 and remaining undetectable through week 16.

IN PRACTICE:

“These data show that the targeting of the plasma-cell compartment by a BCMA-targeted T-cell engager is feasible in patients with autoimmune disease. Whether such therapy results in sustained clinical remission warrants further study,” write the authors of the four-patient case series.

SOURCE: 

Melanie Hagen, MD, Friedrich Alexander University Erlangen–Nuremberg, Germany, and colleagues reported their case series online in The New England Journal of Medicine. Tobias Alexander, MD, and colleagues at Charité–Universitätsmedizin Berlin, Germany, also described their single case report in The New England Journal of Medicine.

LIMITATIONS:

The small number of patients limits the generalizability of the findings. The short duration of follow-up may not capture long-term effects and potential late-onset adverse events. The lack of a control group makes it difficult to attribute improvements solely to teclistamab therapy.

DISCLOSURES:

The four-patient case series was supported by grants from the Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the European Union. The single case report was supported by grants from the Deutsche Forschungsgemeinschaft and the European Union. Several authors have disclosed financial relationships with pharmaceutical companies, including Janssen Biotech, which markets teclistamab.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

Teclistamab, a T-cell engager that targets B-cell maturation antigen (BCMA), improved disease activity in four patients with refractory autoimmune conditions. In a separately published case report, teclistamab treatment induced remission in a patient with refractory systemic lupus erythematosus (SLE).

BACKGROUND: 

• Chimeric antigen receptor (CAR) T cells or T-cell engagers against CD19 have been effective in small studies of patients with treatment-resistant autoimmune diseases.
• Some patients have disease rooted in long-lived plasma cells that express BCMA but not CD19, making them resistant to CD19 CAR T-cell therapy.
• Teclistamab acts on T cells through CD3 and targets plasmablasts and plasma cells through BCMA.

METHODOLOGY:

• In one case series, researchers administered teclistamab subcutaneously to four patients with autoimmune diseases resistant to more than five immunosuppressants, including rituximab.
• Patient 1 had systemic sclerosis, patient 2 had primary Sjögren disease, patient 3 had idiopathic inflammatory myositis, and patient 4 had rheumatoid arthritis.
• Researchers incrementally increased teclistamab dosage in an inpatient setting: 0.06 mg/kg on day 1, 0.3 mg/kg on day 3, and 1.5 mg/kg on day 5. Patients 2, 3, and 4 received one maintenance dose of 1.5 mg/kg after 4 weeks, and patient 1 received a 1.5-mg/kg dose after 12 weeks.
• In the single case report, the patient with SLE received a step-up dosage of teclistamab (0.06 mg/kg and 0.3 mg/kg) followed by 0.8 mg/kg on day 7. She received 1.5 mg/kg at weeks 2 and 5.

TAKEAWAY: 

• Teclistamab therapy led to significant improvements in disease activity in all four patients, with notable reductions in skin disease, arthritis, and lung function scores.
• Teclistamab therapy had a good safety profile, with no neurotoxicity or myelotoxicity and only lower-grade cytokine release syndrome reported.
• Researchers observed seroconversion of PM-Scl-75, PM-Scl-100, rheumatoid factor, and autoantibodies against mutated citrullinated vimentin and lower levels of autoantibodies ANA, MDAS, SS-A/Ro, SS-B/La, and PL-7 after treatment.
• In the separate case report, the patient reached complete drug-free remission by week 6, as defined by the Systemic Lupus Erythematosus Disease Activity Index 2000.
• The level of anti–double-stranded DNA antibodies in the patient with SLE decreased rapidly, reaching normal range by week 5 and remaining undetectable through week 16.

IN PRACTICE:

“These data show that the targeting of the plasma-cell compartment by a BCMA-targeted T-cell engager is feasible in patients with autoimmune disease. Whether such therapy results in sustained clinical remission warrants further study,” write the authors of the four-patient case series.

SOURCE: 

Melanie Hagen, MD, Friedrich Alexander University Erlangen–Nuremberg, Germany, and colleagues reported their case series online in The New England Journal of Medicine. Tobias Alexander, MD, and colleagues at Charité–Universitätsmedizin Berlin, Germany, also described their single case report in The New England Journal of Medicine.

LIMITATIONS:

The small number of patients limits the generalizability of the findings. The short duration of follow-up may not capture long-term effects and potential late-onset adverse events. The lack of a control group makes it difficult to attribute improvements solely to teclistamab therapy.

DISCLOSURES:

The four-patient case series was supported by grants from the Deutsche Forschungsgemeinschaft, Bundesministerium für Bildung und Forschung, and the European Union. The single case report was supported by grants from the Deutsche Forschungsgemeinschaft and the European Union. Several authors have disclosed financial relationships with pharmaceutical companies, including Janssen Biotech, which markets teclistamab.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the NYU Grossman School of Medicine in New York City. 

We have many debates and arguments that are swirling around about the out-of-control costs of Medicare. Many people are arguing we’ve got to trim it and cut back, and many people note that we can’t just go on and on with that kind of expenditure.

People look around for savings. Rightly, we can’t go on with the prices that we’re paying. No system could. We’ll bankrupt ourselves if we don’t drive prices down. 

There’s another area that is driving up cost where, despite the fact that Medicare doesn’t pay for it, we could capture resources and hopefully shift them back to things like Medicare coverage or the insurance of other efficacious procedures. That area is the wellness industry. 

I looked up a number recently, and I was shocked to see that worldwide, $1.8 trillion is being spent on wellness, including billions in the US. Again, Medicare doesn’t pay for that. That’s money coming out of people’s pockets that we could hopefully aim at the payment of things that we know work, not seeing the money drain out to cover bunk, nonsense, and charlatanism.

Does any or most of this stuff work? Do anything? Help anybody? No. We are spending money on charlatans and quacks. The US Food and Drug Administration (FDA), which you might think is the agency that could step in and start to get rid of some of this nonsense, is just too overwhelmed trying to track drugs, devices, and vaccines to give much attention to the wellness industry.

What am I talking about specifically? I’m talking about everything from gut probiotics that are sold in sodas to probiotic facial creams and the Goop industry of Gwyneth Paltrow, where you have people buying things like wellness mats or vaginal eggs that are supposed to maintain gynecologic health.

We’re talking about things like PEMF, or pulse electronic magnetic fields, where you buy a machine and expose yourself to mild magnetic pulses. I went online to look them up, and the machines cost $5000-$50,000. There’s no evidence that it works. By the way, the machines are not only out there as being sold for pain relief and many other things to humans, but also they’re being sold for your pets.

That industry is completely out of control. Wellness interventions, whether it’s transcranial magnetism or all manner of supplements that are sold in health food stores, over and over again, we see a world in which wellness is promoted but no data are introduced to show that any of it helps, works, or does anybody any good.

It may not be all that harmful, but it’s certainly financially toxic to many people who end up spending good amounts of money using these things. I think doctors need to ask patients if they are using any of these things, particularly if they have chronic conditions. They’re likely, many of them, to be seduced by online advertisement to get involved with this stuff because it’s preventive or it’ll help treat some condition that they have. 

The industry is out of control. We’re trying to figure out how to spend money on things we know work in medicine, and yet we continue to tolerate bunk, nonsense, quackery, and charlatanism, just letting it grow and grow and grow in terms of cost.

That’s money that could go elsewhere. That is money that is being taken out of the pockets of patients. They’re doing things that may even delay medical treatment, which won’t really help them, and they are doing things that perhaps might even interfere with medical care that really is known to be beneficial.

I think it’s time to push for more money for the FDA to regulate the wellness side. I think it’s time for the Federal Trade Commission to go after ads that promise health benefits. I think it’s time to have some honest conversations with patients: What are you using? What are you doing? Tell me about it, and here’s why I think you could probably spend your money in a better way. 
 

Dr. Caplan, director, Division of Medical Ethics, New York University Langone Medical Center, New York, disclosed ties with Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He serves as a contributing author and adviser for Medscape.

A version of this article appeared on Medscape.com.