Thomas R. Collins

Advancements in tools for assessing the function of the esophagus have led to important refinements in the diagnosis of achalasia and achalasia-like conditions, at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.

“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”

High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.

“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”

HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.

In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.

Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.

In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.

The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.

“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”

Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.

Advancements in tools for assessing the function of the esophagus have led to important refinements in the diagnosis of achalasia and achalasia-like conditions, at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.

“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”

High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.

“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”

HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.

In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.

Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.

In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.

The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.

“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”

Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.

Advancements in tools for assessing the function of the esophagus have led to important refinements in the diagnosis of achalasia and achalasia-like conditions, at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.

“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”

High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.

“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”

HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.

In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.

Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.

In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.

The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.

“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”

Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.

In the wake of newly issued guidance by the American College of Physicians, the American Gastroenterological Association is advising clinicians to follow the 2021 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) which recommend that average risk individuals be screened beginning at age 45.

The ACP, in a new guidance, says that “clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The guidance is at odds with the recommendations from the task force, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy. The consensus was that people ages 45 and up should receive CRC screening.

“We’re disappointed that the ACP has suggested to not screen average-risk individuals between the ages of 45 to 49,” said Swati Patel, MD, MS, a member of the USMSTF, the lead author on the recent USMSTF guidance, and associate professor of medicine-gastroenterology at the University of Colorado at Denver, Aurora. “This guidance essentially contradicts these other organizations, and I think from the patient perspective, likely raises a lot of confusion.”

Barbara Jung, MD, AGAF, president of the AGA said in a written statement: “Studies show that colorectal cancer is increasing in younger patients and we have data backing screening for average-risk patients at 45. Bottomline: it saves lives. To release contradictory guidance is reckless.”

Timothy Wilt, MD, MPH, professor of medicine at the University of Minnesota, Minneapolis, and past chair of the guidelines committee at the ACP, said that a key consideration for the ACP was what they considered an “incredibly small” increase in CRC incidence in people under 50 from 2000 to 2019 – from 6.0 per 100,000 to 8.7 per 100,000.

“If I would tell my patients, your chance of colorectal cancer is 6 per 100,000 and now it’s really 9 per 100,000, they would say, ‘No thanks,’ ” he said. “I have trouble getting my patients to take a statin for heart disease when their risk of heart disease in the future is 25%.”

Dr. Patel said that these incidence numbers don’t capture the magnitude of the CRC health burden, because screening historically hadn’t been performed on those under 50. A 2020 study that broke incidence down in single-year increments found a 46% jump from age 49 to age 50, she noted.

“We only diagnose a cancer once we check for it,” she said. The dramatic jump in CRC incidence at age 50 isn’t a sign of new cancer, she said. Rather, these cancers have “been there for years and are cancers that would have been detected between 45 and 49. We just didn’t know about them because patients didn’t get the colonoscopy.”

Data show that 16% of all rectal cancer now occur in patients under 50, she said.

“That is a substantial proportion of all rectal cancers,” she said. “If these trends continue without us doing something about it, that suggests that colon cancer and rectal cancer will be the leading cause of cancer-related death in individuals under the age of 50 by 2030. That’s not that far away.”

Moreover, she said, when the ACP says in its guidance that “the small estimated benefits and harms roughly balance each other out,” it overestimates the risk of CRC screening. The first step, which includes noninvasive options such as a stool-based screen, is no-risk and needs to be followed by a colonoscopy only in a small percentage of cases, she noted. And in recent randomized controlled trials, out of more than 28,000 colonoscopies, there were two perforations, 30 bleeding events, and no deaths.

“I think the ACP statement very much overinflates the risks of screening,” she said.

Dr. Wilt suggested that guidance that flatly recommends that screening should start at age 45 is an overly blunt strategy, not accounting for lower CRC rates among women and varying risk for different races and ethnicities – information that patients should be given in order to make decisions.

“What I would say is, talk to your physicians, ask about the information, make a clinical decision that’s right for you. ... It’s your health,” he said. “We believe our guidance statements are incredibly patient-centered.”

Dr. Patel said that such an approach is not necessarily what patients look for from their physicians.

“I think in theory it’s great to have quote-unquote shared decision-making, and empower the patient to make a decision,” she said. “But generally speaking, patients seek our advice and seek our expertise to synthesize all of this complex data, to provide a recommendation that is driven by those data points.”

The ACP guidance also suggests that “opportunity costs and resources need to be weighed” and that expanding the screening population will take resources away from other medical services.

“We are the front-line docs who have to engage in these conversations,” Dr. Wilt said. “We value our GI and specialty consultants (but) they are not the ones who are there at the front line having to have these discussions.”

Dr. Patel agreed that, with expanded screening, primary care physicians need more support and that “we have a long way to go in providing those support resources.” But she added, “my perspective is that we have to look agnostically at the data.” The data the AGA cites, she added, are peer-reviewed, epidemiological data, not society-generated data.

“I don’t agree with the approach of, even though it’s an additional burden, because we don’t have the resources and time now, to just not proceed,” she said.

“I think our hope would be that practicing physicians – either within the ACP or outside – just have a clear message to patients, that colon cancer is a big deal, it’s increasing in young patients, starting at age 45 you should be screened, and you should use the test that you’re most likely to get done.”
 

In the wake of newly issued guidance by the American College of Physicians, the American Gastroenterological Association is advising clinicians to follow the 2021 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) which recommend that average risk individuals be screened beginning at age 45.

The ACP, in a new guidance, says that “clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The guidance is at odds with the recommendations from the task force, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy. The consensus was that people ages 45 and up should receive CRC screening.

“We’re disappointed that the ACP has suggested to not screen average-risk individuals between the ages of 45 to 49,” said Swati Patel, MD, MS, a member of the USMSTF, the lead author on the recent USMSTF guidance, and associate professor of medicine-gastroenterology at the University of Colorado at Denver, Aurora. “This guidance essentially contradicts these other organizations, and I think from the patient perspective, likely raises a lot of confusion.”

Barbara Jung, MD, AGAF, president of the AGA said in a written statement: “Studies show that colorectal cancer is increasing in younger patients and we have data backing screening for average-risk patients at 45. Bottomline: it saves lives. To release contradictory guidance is reckless.”

Timothy Wilt, MD, MPH, professor of medicine at the University of Minnesota, Minneapolis, and past chair of the guidelines committee at the ACP, said that a key consideration for the ACP was what they considered an “incredibly small” increase in CRC incidence in people under 50 from 2000 to 2019 – from 6.0 per 100,000 to 8.7 per 100,000.

“If I would tell my patients, your chance of colorectal cancer is 6 per 100,000 and now it’s really 9 per 100,000, they would say, ‘No thanks,’ ” he said. “I have trouble getting my patients to take a statin for heart disease when their risk of heart disease in the future is 25%.”

Dr. Patel said that these incidence numbers don’t capture the magnitude of the CRC health burden, because screening historically hadn’t been performed on those under 50. A 2020 study that broke incidence down in single-year increments found a 46% jump from age 49 to age 50, she noted.

“We only diagnose a cancer once we check for it,” she said. The dramatic jump in CRC incidence at age 50 isn’t a sign of new cancer, she said. Rather, these cancers have “been there for years and are cancers that would have been detected between 45 and 49. We just didn’t know about them because patients didn’t get the colonoscopy.”

Data show that 16% of all rectal cancer now occur in patients under 50, she said.

“That is a substantial proportion of all rectal cancers,” she said. “If these trends continue without us doing something about it, that suggests that colon cancer and rectal cancer will be the leading cause of cancer-related death in individuals under the age of 50 by 2030. That’s not that far away.”

Moreover, she said, when the ACP says in its guidance that “the small estimated benefits and harms roughly balance each other out,” it overestimates the risk of CRC screening. The first step, which includes noninvasive options such as a stool-based screen, is no-risk and needs to be followed by a colonoscopy only in a small percentage of cases, she noted. And in recent randomized controlled trials, out of more than 28,000 colonoscopies, there were two perforations, 30 bleeding events, and no deaths.

“I think the ACP statement very much overinflates the risks of screening,” she said.

Dr. Wilt suggested that guidance that flatly recommends that screening should start at age 45 is an overly blunt strategy, not accounting for lower CRC rates among women and varying risk for different races and ethnicities – information that patients should be given in order to make decisions.

“What I would say is, talk to your physicians, ask about the information, make a clinical decision that’s right for you. ... It’s your health,” he said. “We believe our guidance statements are incredibly patient-centered.”

Dr. Patel said that such an approach is not necessarily what patients look for from their physicians.

“I think in theory it’s great to have quote-unquote shared decision-making, and empower the patient to make a decision,” she said. “But generally speaking, patients seek our advice and seek our expertise to synthesize all of this complex data, to provide a recommendation that is driven by those data points.”

The ACP guidance also suggests that “opportunity costs and resources need to be weighed” and that expanding the screening population will take resources away from other medical services.

“We are the front-line docs who have to engage in these conversations,” Dr. Wilt said. “We value our GI and specialty consultants (but) they are not the ones who are there at the front line having to have these discussions.”

Dr. Patel agreed that, with expanded screening, primary care physicians need more support and that “we have a long way to go in providing those support resources.” But she added, “my perspective is that we have to look agnostically at the data.” The data the AGA cites, she added, are peer-reviewed, epidemiological data, not society-generated data.

“I don’t agree with the approach of, even though it’s an additional burden, because we don’t have the resources and time now, to just not proceed,” she said.

“I think our hope would be that practicing physicians – either within the ACP or outside – just have a clear message to patients, that colon cancer is a big deal, it’s increasing in young patients, starting at age 45 you should be screened, and you should use the test that you’re most likely to get done.”
 

In the wake of newly issued guidance by the American College of Physicians, the American Gastroenterological Association is advising clinicians to follow the 2021 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer (MSTF) which recommend that average risk individuals be screened beginning at age 45.

The ACP, in a new guidance, says that “clinicians should consider not screening asymptomatic average-risk adults between the ages of 45 to 49 years. Clinicians should discuss the uncertainty around benefits and harms of screening in this population.”

The guidance is at odds with the recommendations from the task force, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy. The consensus was that people ages 45 and up should receive CRC screening.

“We’re disappointed that the ACP has suggested to not screen average-risk individuals between the ages of 45 to 49,” said Swati Patel, MD, MS, a member of the USMSTF, the lead author on the recent USMSTF guidance, and associate professor of medicine-gastroenterology at the University of Colorado at Denver, Aurora. “This guidance essentially contradicts these other organizations, and I think from the patient perspective, likely raises a lot of confusion.”

Barbara Jung, MD, AGAF, president of the AGA said in a written statement: “Studies show that colorectal cancer is increasing in younger patients and we have data backing screening for average-risk patients at 45. Bottomline: it saves lives. To release contradictory guidance is reckless.”

Timothy Wilt, MD, MPH, professor of medicine at the University of Minnesota, Minneapolis, and past chair of the guidelines committee at the ACP, said that a key consideration for the ACP was what they considered an “incredibly small” increase in CRC incidence in people under 50 from 2000 to 2019 – from 6.0 per 100,000 to 8.7 per 100,000.

“If I would tell my patients, your chance of colorectal cancer is 6 per 100,000 and now it’s really 9 per 100,000, they would say, ‘No thanks,’ ” he said. “I have trouble getting my patients to take a statin for heart disease when their risk of heart disease in the future is 25%.”

Dr. Patel said that these incidence numbers don’t capture the magnitude of the CRC health burden, because screening historically hadn’t been performed on those under 50. A 2020 study that broke incidence down in single-year increments found a 46% jump from age 49 to age 50, she noted.

“We only diagnose a cancer once we check for it,” she said. The dramatic jump in CRC incidence at age 50 isn’t a sign of new cancer, she said. Rather, these cancers have “been there for years and are cancers that would have been detected between 45 and 49. We just didn’t know about them because patients didn’t get the colonoscopy.”

Data show that 16% of all rectal cancer now occur in patients under 50, she said.

“That is a substantial proportion of all rectal cancers,” she said. “If these trends continue without us doing something about it, that suggests that colon cancer and rectal cancer will be the leading cause of cancer-related death in individuals under the age of 50 by 2030. That’s not that far away.”

Moreover, she said, when the ACP says in its guidance that “the small estimated benefits and harms roughly balance each other out,” it overestimates the risk of CRC screening. The first step, which includes noninvasive options such as a stool-based screen, is no-risk and needs to be followed by a colonoscopy only in a small percentage of cases, she noted. And in recent randomized controlled trials, out of more than 28,000 colonoscopies, there were two perforations, 30 bleeding events, and no deaths.

“I think the ACP statement very much overinflates the risks of screening,” she said.

Dr. Wilt suggested that guidance that flatly recommends that screening should start at age 45 is an overly blunt strategy, not accounting for lower CRC rates among women and varying risk for different races and ethnicities – information that patients should be given in order to make decisions.

“What I would say is, talk to your physicians, ask about the information, make a clinical decision that’s right for you. ... It’s your health,” he said. “We believe our guidance statements are incredibly patient-centered.”

Dr. Patel said that such an approach is not necessarily what patients look for from their physicians.

“I think in theory it’s great to have quote-unquote shared decision-making, and empower the patient to make a decision,” she said. “But generally speaking, patients seek our advice and seek our expertise to synthesize all of this complex data, to provide a recommendation that is driven by those data points.”

The ACP guidance also suggests that “opportunity costs and resources need to be weighed” and that expanding the screening population will take resources away from other medical services.

“We are the front-line docs who have to engage in these conversations,” Dr. Wilt said. “We value our GI and specialty consultants (but) they are not the ones who are there at the front line having to have these discussions.”

Dr. Patel agreed that, with expanded screening, primary care physicians need more support and that “we have a long way to go in providing those support resources.” But she added, “my perspective is that we have to look agnostically at the data.” The data the AGA cites, she added, are peer-reviewed, epidemiological data, not society-generated data.

“I don’t agree with the approach of, even though it’s an additional burden, because we don’t have the resources and time now, to just not proceed,” she said.

“I think our hope would be that practicing physicians – either within the ACP or outside – just have a clear message to patients, that colon cancer is a big deal, it’s increasing in young patients, starting at age 45 you should be screened, and you should use the test that you’re most likely to get done.”
 

Using the adenoma detection rate (ADR) for all colonoscopies could be just as good as using the more traditional ADR approach of using only colonoscopies that are performed for screening purposes, a new paper suggests.

The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.

“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”

The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.

The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.

No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.

Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.

The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.

When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.

The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.

“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”

In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.

“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.

The authors disclosed no conflicts of interest.

Using the adenoma detection rate (ADR) for all colonoscopies could be just as good as using the more traditional ADR approach of using only colonoscopies that are performed for screening purposes, a new paper suggests.

The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.

“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”

The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.

The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.

No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.

Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.

The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.

When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.

The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.

“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”

In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.

“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.

The authors disclosed no conflicts of interest.

Using the adenoma detection rate (ADR) for all colonoscopies could be just as good as using the more traditional ADR approach of using only colonoscopies that are performed for screening purposes, a new paper suggests.

The findings, published earlier this year in Gastroenterology, point to a potentially simpler approach to the ADR, an established colonoscopy quality metric that measures the percentage of colonoscopies in which at least one adenoma was found, the researchers said, because of the complexities posed by separating out screening colonoscopies from those for other indications.

“Methods for ascertaining colonoscopy indication include manual review, electronic medical record queries, and text string searches of colonoscopy reports, which are resource-intensive and subject to misclassification,” said the researchers, led by Douglas Corley, MD, PhD, MPH, and Christopher Jensen, PhD, researchers at Kaiser Permanente Northern California. “These barriers have impeded the universal adoption of screening ADR reporting and suggest the need for a simpler, valid alternative to screening ADR.”

The analysis included Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and the University of Texas Southwestern’s Parkland Memorial Hospital – large, demographically diverse, community-based health systems with 45 endoscopy centers and covering about 3% of the U.S. population. The data that were assessed covered 487 endoscopists who performed 1,046,916 cancer-negative colonoscopies from January 2011 to June 2019.

The median overall ADR was 36.3%; the median screening, ADR 29.7%; the diagnostic ADR, 37.1%; and the surveillance ADR, 48.6%.

No matter the colonoscopy indication, the researchers found, ADRs were similarly inversely related to the risk of post-colonoscopy colorectal cancer (PCCRC) rate. For patients of physicians with ADRs of 45% or more, using the group with a less than 25% ADR as the reference group, the risk hazard ratio for the overall ADRs was 0.44, and for the screening ADRs, it was 0.43.

Researchers also found that the quartile of overall ADR had a similar overall predictive ability for PCCRC to the quartile of screening ADR – both with a C-statistic of 0.71.

The overall ADR did just about as well as the screening ADR in identifying physician performance quartile groupings – especially in the case of the lowest quartile. Among the 293 endoscopists who performed colonoscopies in 2017-2018, for instance, 62 of the 73 providers who were in the lowest quartile for screening ADR were also in the lowest quartile for the overall ADR, the researchers found. And there were no providers who differed by more than one quartile.

When considering all quartiles, 69.6% of endoscopists had identical quartile rankings for overall ADR and screening ADR, 29.4% differed by one quartile, and only 1% differed by two quartiles.

The inclination to use screening colonoscopies to compute ADR metrics was intended to promote uniformity in the field, but this might not be the best practice, the researchers suggest.

“Given the large differences in screening ADRs between settings and the potential for indication misclassification, it is not clear that restricting ADR calculations to screening colonoscopies allows for a more ‘apples-to-apples’ comparison across settings than methods that include all colonoscopies,” they said. “The current study found that overall ADR as a quality metric performed similarly to screening ADR for predicting PCCRC and identifying the same providers in the lowest quartile. In addition, it is simpler to calculate, not susceptible to indication misclassification or potential provider-related biases, and more precise because it includes many more colonoscopies.”

In an editorial that was published in Gastroenterology, Jill Tinmouth, MD, PhD, University of Toronto, and Catherine Dubé, MD, University of Ottawa, noted that measuring ADR is valuable only if it improves the quality of colonoscopies.

“Ultimately, this new approach to measuring ADR and identifying underperformance is only valuable if it leads to improvement in colonoscopy quality. The approach proposed by Corley et al. should make it easier for facilities, screening programs, and jurisdictions to measure ADR, and this is an important first step. However, to move the dial on quality, reporting ADR needs to be accompanied by physician uptake of strategies to improve their colonoscopy performance, that is, split-dose bowel preparation, proper insertion and withdrawal techniques ([e.g.], careful cleaning and inspection and turning the patient, when possible), and improved polypectomy skills,” they wrote.

The authors disclosed no conflicts of interest.

Medications taken by prospective fathers for inflammatory bowel disease (IBD) do not seem to affect fertility or birth outcomes, according to a systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.

The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.

“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”

Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.

Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.

Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.

In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.

Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.

A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.

“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.

“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”

The authors disclosed no conflicts of interest.

Medications taken by prospective fathers for inflammatory bowel disease (IBD) do not seem to affect fertility or birth outcomes, according to a systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.

The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.

“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”

Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.

Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.

Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.

In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.

Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.

A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.

“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.

“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”

The authors disclosed no conflicts of interest.

Medications taken by prospective fathers for inflammatory bowel disease (IBD) do not seem to affect fertility or birth outcomes, according to a systematic review and meta-analysis published in Clinical Gastroenterology and Hepatology.

The effort is the first meta-analysis to assess semen parameters and the risk of adverse outcomes in pregnancy for male patients with IBD who have taken biologics, thiopurines or methotrexate for the condition, the researchers said.

“We provide encouraging evidence that biologic, thiopurine, and methotrexate therapy among male patients with IBD are not associated with impairments in male fertility or with increased risk of adverse pregnancy outcomes,” said the researchers, led in part by John Gubatan, MD, instructor in medicine at Stanford (Calif.) University, who worked with investigators in Copenhagen and Toronto. “Taken together, our data support the safety of continuing biologics, thiopurines, or methotrexate across the reproductive spectrum.”

Questions of fertility and pregnancy outcomes are of particular importance in IBD, since patients are often diagnosed around the time of their reproductive years – about 30 years old for Crohn’s disease and 35 years old for ulcerative colitis. There has been far more research attention paid to female than male reproductive considerations, mainly the health of the fetus when the mother takes biologic therapy for IBD during pregnancy, which has generally found to be safe.

Their search found 13 studies with male IBD patients exposed to biologics, 10 exposed to thiopurines and 6 to methotrexate. Researchers extracted data on sperm count, sperm motility, and abnormal sperm morphology – three metrics considered a proxy for male fertility – as well as early pregnancy loss, preterm birth and congenital malformations.

Researchers found no differences between sperm count, motility or morphology between those exposed and not exposed to biologics, thiopurines and methotrexate, with a couple of exceptions. They actually found that sperm count was higher for thiopurine users, compared with nonusers, and there was only one study on methotrexate and abnormal sperm morphology, so there was no data to pool together for that comparison.

In a subgroup analysis, there was a trend toward higher sperm count in thiopurine users, compared with biologic or methotrexate users, but no differences were seen in the other parameters.

Similarly, there were no significant differences for users and nonusers of these medications for early pregnancy loss, preterm births or congenital malformations, the researchers found.

A prior systematic review suggested that azathioprine might be associated with low sperm count, but this new analysis calls that into question.

“Our results, which demonstrated that thiopurine use among male patients with IBD is associated with increased sperm count, refute this prior finding,” the researchers said. The previous finding, they noted, was only qualitative because the authors didn’t do an analysis to calculate effect size or determine statistical significance.

“Furthermore,” the researchers said, “our study included more updated studies and a greater number of patients.”

The authors disclosed no conflicts of interest.

The interleukin-23 (IL-23) inhibitor mirikizumab performed better than placebo for ulcerative colitis with patients showing good results on histological testing and control of bowel movements, according to new findings from the phase 3 LUCENT-1 induction and LUCENT-2 maintenance trials. The findings were reported in the New England Journal of Medicine.

Mirikizumab manufacturer Eli Lilly, which funded the study, is hoping the drug will become the first IL-23 inhibitor to be approved in the United States for ulcerative colitis. The drug targets the p19 subunit that is unique to IL-23. Ustekinumab, which targets the p40 subunit that is shared by IL-12 and IL-23, has been approved for UC and Crohn’s disease. Risankizumab, which targets the IL-23 p19 subunit, has been approved for Crohn’s treatment.

Earlier this year, the Food and Drug Administration rejected Lilly’s mirikizumab application over manufacturing issues, with no concerns about the clinical data, safety, or labelling. The company said it was working with the FDA to resolve the concerns, and hopes to “launch mirikizumab in the U.S. as soon as possible.” The drug has already been approved in Japan for moderately and severely active ulcerative colitis, and the drug was reviewed favorably by the European Medicines Agency.

Since 2014, the market size of interleukin inhibitors has grown fivefold with the greatest share belonging to IL-23 inhibitors.

The induction trial included 1,281 patients with moderately or severely active ulcerative colitis (UC), and 544 patients who had a response to mirikizumab were randomized again in the maintenance phase.

Significantly more patients in the mirikizumab arm – 24.1% (P < .001) – had clinical remission at week 12, although there was a high placebo remission rate, as is often seen in UC trials, at 13.3%. At week 40 of the maintenance trial, 49.9% of those on mirikizumab had clinical remission, compared to 25.1% for placebo (P < .001).

Mirikizumab also performed better than placebo on the trial’s five secondary endpoints: glucocorticoid-free clinical remission (44.9% to 21.8%), maintenance of clinical remission (63.6% to 36.9%), endoscopic remission (58.6% to 29.1%), histologic-endoscopic mucosal remission (43.3 %), and bowel-urgency remission (42.9% to 25.0%) (P < .001 for all).

Researchers led by Geert D’Haens, MD, PhD, professor of gastroenterology at Amsterdam University Medical Centers, emphasized the effects on acute inflammatory cell infiltration.

“Current recommendations for the treatment of ulcerative colitis include increasingly rigorous goals beyond symptomatic or endoscopic improvement,” the authors wrote. “Recent literature has recommended the absence of intraepithelial neutrophils as a minimal requirement for remission on the basis of histologic testing. After 1 year of mirikizumab treatment, more than 40% of the patients in the LUCENT-1 and LUCENT-2 trials had no mucosal neutrophils. “

Urgency NRS (Numeric Rating Scale) – a measure developed by Lilly in which patients report the urgency of bowel movements over the previous 24 hours – was used in the trial.

“Many patients with ulcerative colitis consider control of bowel movements to be more important than rectal bleeding or stool frequency,” the researchers said. “In the induction trial, patients reported reductions in bowel urgency with mirikizumab therapy, which were sustained during the maintenance trial.”

Of the 1,217 patients treated with mirikizumab during the placebo-controlled and non–placebo-controlled periods, opportunistic infections were seen in 15, with 6 herpes zoster infections. One case of an opportunistic infection was seen in a patient receiving placebo in the induction trial.

Cancer was seen in eight of the mirikizumab-treated patients, with adenocarcinoma of the colon in two patients in the induction trial. No cancers were seen in patients receiving placebo in induction.

“Additional and longer trials are ongoing,” the researchers said, “to further assess the efficacy and safety of mirikizumab therapy in patients with ulcerative colitis.”

The authors disclosed consultancies, or other relationships, with a number of pharmaceutical companies, including Eli Lilly, the maker of mirikizumab.

The interleukin-23 (IL-23) inhibitor mirikizumab performed better than placebo for ulcerative colitis with patients showing good results on histological testing and control of bowel movements, according to new findings from the phase 3 LUCENT-1 induction and LUCENT-2 maintenance trials. The findings were reported in the New England Journal of Medicine.

Mirikizumab manufacturer Eli Lilly, which funded the study, is hoping the drug will become the first IL-23 inhibitor to be approved in the United States for ulcerative colitis. The drug targets the p19 subunit that is unique to IL-23. Ustekinumab, which targets the p40 subunit that is shared by IL-12 and IL-23, has been approved for UC and Crohn’s disease. Risankizumab, which targets the IL-23 p19 subunit, has been approved for Crohn’s treatment.

Earlier this year, the Food and Drug Administration rejected Lilly’s mirikizumab application over manufacturing issues, with no concerns about the clinical data, safety, or labelling. The company said it was working with the FDA to resolve the concerns, and hopes to “launch mirikizumab in the U.S. as soon as possible.” The drug has already been approved in Japan for moderately and severely active ulcerative colitis, and the drug was reviewed favorably by the European Medicines Agency.

Since 2014, the market size of interleukin inhibitors has grown fivefold with the greatest share belonging to IL-23 inhibitors.

The induction trial included 1,281 patients with moderately or severely active ulcerative colitis (UC), and 544 patients who had a response to mirikizumab were randomized again in the maintenance phase.

Significantly more patients in the mirikizumab arm – 24.1% (P < .001) – had clinical remission at week 12, although there was a high placebo remission rate, as is often seen in UC trials, at 13.3%. At week 40 of the maintenance trial, 49.9% of those on mirikizumab had clinical remission, compared to 25.1% for placebo (P < .001).

Mirikizumab also performed better than placebo on the trial’s five secondary endpoints: glucocorticoid-free clinical remission (44.9% to 21.8%), maintenance of clinical remission (63.6% to 36.9%), endoscopic remission (58.6% to 29.1%), histologic-endoscopic mucosal remission (43.3 %), and bowel-urgency remission (42.9% to 25.0%) (P < .001 for all).

Researchers led by Geert D’Haens, MD, PhD, professor of gastroenterology at Amsterdam University Medical Centers, emphasized the effects on acute inflammatory cell infiltration.

“Current recommendations for the treatment of ulcerative colitis include increasingly rigorous goals beyond symptomatic or endoscopic improvement,” the authors wrote. “Recent literature has recommended the absence of intraepithelial neutrophils as a minimal requirement for remission on the basis of histologic testing. After 1 year of mirikizumab treatment, more than 40% of the patients in the LUCENT-1 and LUCENT-2 trials had no mucosal neutrophils. “

Urgency NRS (Numeric Rating Scale) – a measure developed by Lilly in which patients report the urgency of bowel movements over the previous 24 hours – was used in the trial.

“Many patients with ulcerative colitis consider control of bowel movements to be more important than rectal bleeding or stool frequency,” the researchers said. “In the induction trial, patients reported reductions in bowel urgency with mirikizumab therapy, which were sustained during the maintenance trial.”

Of the 1,217 patients treated with mirikizumab during the placebo-controlled and non–placebo-controlled periods, opportunistic infections were seen in 15, with 6 herpes zoster infections. One case of an opportunistic infection was seen in a patient receiving placebo in the induction trial.

Cancer was seen in eight of the mirikizumab-treated patients, with adenocarcinoma of the colon in two patients in the induction trial. No cancers were seen in patients receiving placebo in induction.

“Additional and longer trials are ongoing,” the researchers said, “to further assess the efficacy and safety of mirikizumab therapy in patients with ulcerative colitis.”

The authors disclosed consultancies, or other relationships, with a number of pharmaceutical companies, including Eli Lilly, the maker of mirikizumab.

The interleukin-23 (IL-23) inhibitor mirikizumab performed better than placebo for ulcerative colitis with patients showing good results on histological testing and control of bowel movements, according to new findings from the phase 3 LUCENT-1 induction and LUCENT-2 maintenance trials. The findings were reported in the New England Journal of Medicine.

Mirikizumab manufacturer Eli Lilly, which funded the study, is hoping the drug will become the first IL-23 inhibitor to be approved in the United States for ulcerative colitis. The drug targets the p19 subunit that is unique to IL-23. Ustekinumab, which targets the p40 subunit that is shared by IL-12 and IL-23, has been approved for UC and Crohn’s disease. Risankizumab, which targets the IL-23 p19 subunit, has been approved for Crohn’s treatment.

Earlier this year, the Food and Drug Administration rejected Lilly’s mirikizumab application over manufacturing issues, with no concerns about the clinical data, safety, or labelling. The company said it was working with the FDA to resolve the concerns, and hopes to “launch mirikizumab in the U.S. as soon as possible.” The drug has already been approved in Japan for moderately and severely active ulcerative colitis, and the drug was reviewed favorably by the European Medicines Agency.

Since 2014, the market size of interleukin inhibitors has grown fivefold with the greatest share belonging to IL-23 inhibitors.

The induction trial included 1,281 patients with moderately or severely active ulcerative colitis (UC), and 544 patients who had a response to mirikizumab were randomized again in the maintenance phase.

Significantly more patients in the mirikizumab arm – 24.1% (P < .001) – had clinical remission at week 12, although there was a high placebo remission rate, as is often seen in UC trials, at 13.3%. At week 40 of the maintenance trial, 49.9% of those on mirikizumab had clinical remission, compared to 25.1% for placebo (P < .001).

Mirikizumab also performed better than placebo on the trial’s five secondary endpoints: glucocorticoid-free clinical remission (44.9% to 21.8%), maintenance of clinical remission (63.6% to 36.9%), endoscopic remission (58.6% to 29.1%), histologic-endoscopic mucosal remission (43.3 %), and bowel-urgency remission (42.9% to 25.0%) (P < .001 for all).

Researchers led by Geert D’Haens, MD, PhD, professor of gastroenterology at Amsterdam University Medical Centers, emphasized the effects on acute inflammatory cell infiltration.

“Current recommendations for the treatment of ulcerative colitis include increasingly rigorous goals beyond symptomatic or endoscopic improvement,” the authors wrote. “Recent literature has recommended the absence of intraepithelial neutrophils as a minimal requirement for remission on the basis of histologic testing. After 1 year of mirikizumab treatment, more than 40% of the patients in the LUCENT-1 and LUCENT-2 trials had no mucosal neutrophils. “

Urgency NRS (Numeric Rating Scale) – a measure developed by Lilly in which patients report the urgency of bowel movements over the previous 24 hours – was used in the trial.

“Many patients with ulcerative colitis consider control of bowel movements to be more important than rectal bleeding or stool frequency,” the researchers said. “In the induction trial, patients reported reductions in bowel urgency with mirikizumab therapy, which were sustained during the maintenance trial.”

Of the 1,217 patients treated with mirikizumab during the placebo-controlled and non–placebo-controlled periods, opportunistic infections were seen in 15, with 6 herpes zoster infections. One case of an opportunistic infection was seen in a patient receiving placebo in the induction trial.

Cancer was seen in eight of the mirikizumab-treated patients, with adenocarcinoma of the colon in two patients in the induction trial. No cancers were seen in patients receiving placebo in induction.

“Additional and longer trials are ongoing,” the researchers said, “to further assess the efficacy and safety of mirikizumab therapy in patients with ulcerative colitis.”

The authors disclosed consultancies, or other relationships, with a number of pharmaceutical companies, including Eli Lilly, the maker of mirikizumab.

ORLANDO – From differentiating them from mimics to choosing the best treatment course, Molly Hinshaw, MD, reviewed some of the ins and outs of managing nail disorders at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dr. Hinshaw, professor of dermatology at the University of Wisconsin, Madison, reviewed several disorders and provided guidance on diagnosis, and achieving the best outcomes for patients.

Pyogenic granuloma (PG) in the nail: These are benign vascular tumors that can mimic more serious conditions, Dr. Hinshaw said. In adults, PG requires a histologic diagnosis, she said.

“So these all really should have a biopsy,” because of potential confusion with amelanotic melanoma or squamous cell carcinoma, she said, although in children, a biopsy is likely not necessary.

Treatment with topical beta-blockers can be effective for PG, she said, and avoids the scarring seen with surgical removal. “These are benign conditions – we want them to go away, but we want these patients to have a functional nail thereafter.”

Periungual or subungual warts: For these warts, which are alongside or under the nail, destructive approaches can cause scarring of the nail bed and are far from optimal, she said.

“We’d like to avoid that, of course.” Therefore, treatments such as lasers and liquid nitrogen “would be much further down, if at all, on my list,” she said.

Injections of the antiviral cidofovir, into the dermis right under the wart, can be highly effective, and one or two treatments is often enough, Dr. Hinshaw said. Sometimes, local anesthesia isn’t even needed for the injection, she said. “This is a wonderful option,” she added.

Dr. Hinshaw is co-owner and chief medical officer of Acure.

ORLANDO – From differentiating them from mimics to choosing the best treatment course, Molly Hinshaw, MD, reviewed some of the ins and outs of managing nail disorders at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dr. Hinshaw, professor of dermatology at the University of Wisconsin, Madison, reviewed several disorders and provided guidance on diagnosis, and achieving the best outcomes for patients.

Pyogenic granuloma (PG) in the nail: These are benign vascular tumors that can mimic more serious conditions, Dr. Hinshaw said. In adults, PG requires a histologic diagnosis, she said.

“So these all really should have a biopsy,” because of potential confusion with amelanotic melanoma or squamous cell carcinoma, she said, although in children, a biopsy is likely not necessary.

Treatment with topical beta-blockers can be effective for PG, she said, and avoids the scarring seen with surgical removal. “These are benign conditions – we want them to go away, but we want these patients to have a functional nail thereafter.”

Periungual or subungual warts: For these warts, which are alongside or under the nail, destructive approaches can cause scarring of the nail bed and are far from optimal, she said.

“We’d like to avoid that, of course.” Therefore, treatments such as lasers and liquid nitrogen “would be much further down, if at all, on my list,” she said.

Injections of the antiviral cidofovir, into the dermis right under the wart, can be highly effective, and one or two treatments is often enough, Dr. Hinshaw said. Sometimes, local anesthesia isn’t even needed for the injection, she said. “This is a wonderful option,” she added.

Dr. Hinshaw is co-owner and chief medical officer of Acure.

ORLANDO – From differentiating them from mimics to choosing the best treatment course, Molly Hinshaw, MD, reviewed some of the ins and outs of managing nail disorders at the ODAC Dermatology, Aesthetic, & Surgical Conference.

Dr. Hinshaw, professor of dermatology at the University of Wisconsin, Madison, reviewed several disorders and provided guidance on diagnosis, and achieving the best outcomes for patients.

Pyogenic granuloma (PG) in the nail: These are benign vascular tumors that can mimic more serious conditions, Dr. Hinshaw said. In adults, PG requires a histologic diagnosis, she said.

“So these all really should have a biopsy,” because of potential confusion with amelanotic melanoma or squamous cell carcinoma, she said, although in children, a biopsy is likely not necessary.

Treatment with topical beta-blockers can be effective for PG, she said, and avoids the scarring seen with surgical removal. “These are benign conditions – we want them to go away, but we want these patients to have a functional nail thereafter.”

Periungual or subungual warts: For these warts, which are alongside or under the nail, destructive approaches can cause scarring of the nail bed and are far from optimal, she said.

“We’d like to avoid that, of course.” Therefore, treatments such as lasers and liquid nitrogen “would be much further down, if at all, on my list,” she said.

Injections of the antiviral cidofovir, into the dermis right under the wart, can be highly effective, and one or two treatments is often enough, Dr. Hinshaw said. Sometimes, local anesthesia isn’t even needed for the injection, she said. “This is a wonderful option,” she added.

Dr. Hinshaw is co-owner and chief medical officer of Acure.

When the Affordable Care Act was signed in 2010, patients became eligible for coverage of screening examinations, which was good news for gastroenterologists and their patients in the fight to prevent colorectal cancer.

But there was a problem: While noninvasive stool tests – measuring microscopic amounts of blood or key DNA mutations, both tip-offs to increased colorectal cancer risk – were considered a screen, the necessary follow-up colonoscopy was not, leaving patients with expensive copays or other payment responsibility.

That interpretation prompted a years-long effort to have the federal agencies who oversee the health insurance sector reinterpret their policy, which finally changed in May 2022. Medicare, which is not covered by the ACA and is administered by a different agency, announced a change to its policy in July 2022, and the change went into effect in January 2023.

“It’s a major victory for patients, and I couldn’t be more delighted,” said David Lieberman, MD, AGAF, professor of medicine in gastroenterology at Oregon Health & Science University, Portland, and former American Gastroenterological Association president, who participated in the effort.

AGA Regulatory Affairs Director Leslie Narramore said AGA Vice President of Public Policy and Advocacy Kathleen Teixeira worked for 10 years, alongside other GI societies and patient advocacy groups, to close the “colonoscopy loophole.” In 2022, the AGA, Fight Colorectal Cancer, and the American Cancer Society–Cancer Action Network met with White House officials and senior officials with the Department of Health & Human Services about expanding the coverage. They also lobbied to eliminate cost-sharing, another way in which preventive colonoscopy is discouraged.

“The COVID-19 public health emergency highlighted health disparities and barriers to access to care,” said Ms. Narramore, who gave input about the effort along with Ms. Teixeira and AGA Director of Government Affairs Sarah Ankney. “The temporary suspension of elective procedures, including screening colonoscopies, exacerbated the existing low colorectal screening rates and created momentum and willingness in agency officials to create positive change.”

Without coverage of the colonoscopy, patients have needed to cover at least part of the cost of the procedure, which could be $1,000 or more with private insurance, or $100 or more with Medicare, Dr. Lieberman said. So, he noted, unsuspecting patients might receive a positive result on a noninvasive test and have a colonoscopy, only to get a “surprise bill.” Or they would know about the lack of coverage and not get the colonoscopy.

“Prior to the policy change, gastroenterologists and their staff had to explain to patients that their insurer would not fully pay for a colonoscopy following a positive noninvasive stool test, and field questions from upset patients who weren’t aware of their insurance plan’s cost-sharing requirements for a cancer screening procedure they thought was free,” Ms. Narramore said.

There’s little doubt the change will help save lives and improve quality of life, Dr. Lieberman said.

“We don’t know the full impact of this new ruling, but we know that financial barriers are important for some patients,” he said. “And so by removing these barriers we hope that we’re going to see improved adherence to follow-up with colonoscopy after a positive stool test, and that would result in reductions in incidence, mortality, and increased life-years gained.”

Ms. Narramore said the changes show the importance of pushing for policy change.

“Our physician advocates were effective in educating policy makers on the need for coverage of the full colorectal cancer screening continuum, and how colorectal cancer needs to be viewed as a program given the various steps necessary for a complete screening,” she said. “These successful efforts demonstrate to our members that advocacy works and that they can be a voice for their patients in improving their access to care.”






 

When the Affordable Care Act was signed in 2010, patients became eligible for coverage of screening examinations, which was good news for gastroenterologists and their patients in the fight to prevent colorectal cancer.

But there was a problem: While noninvasive stool tests – measuring microscopic amounts of blood or key DNA mutations, both tip-offs to increased colorectal cancer risk – were considered a screen, the necessary follow-up colonoscopy was not, leaving patients with expensive copays or other payment responsibility.

That interpretation prompted a years-long effort to have the federal agencies who oversee the health insurance sector reinterpret their policy, which finally changed in May 2022. Medicare, which is not covered by the ACA and is administered by a different agency, announced a change to its policy in July 2022, and the change went into effect in January 2023.

“It’s a major victory for patients, and I couldn’t be more delighted,” said David Lieberman, MD, AGAF, professor of medicine in gastroenterology at Oregon Health & Science University, Portland, and former American Gastroenterological Association president, who participated in the effort.

AGA Regulatory Affairs Director Leslie Narramore said AGA Vice President of Public Policy and Advocacy Kathleen Teixeira worked for 10 years, alongside other GI societies and patient advocacy groups, to close the “colonoscopy loophole.” In 2022, the AGA, Fight Colorectal Cancer, and the American Cancer Society–Cancer Action Network met with White House officials and senior officials with the Department of Health & Human Services about expanding the coverage. They also lobbied to eliminate cost-sharing, another way in which preventive colonoscopy is discouraged.

“The COVID-19 public health emergency highlighted health disparities and barriers to access to care,” said Ms. Narramore, who gave input about the effort along with Ms. Teixeira and AGA Director of Government Affairs Sarah Ankney. “The temporary suspension of elective procedures, including screening colonoscopies, exacerbated the existing low colorectal screening rates and created momentum and willingness in agency officials to create positive change.”

Without coverage of the colonoscopy, patients have needed to cover at least part of the cost of the procedure, which could be $1,000 or more with private insurance, or $100 or more with Medicare, Dr. Lieberman said. So, he noted, unsuspecting patients might receive a positive result on a noninvasive test and have a colonoscopy, only to get a “surprise bill.” Or they would know about the lack of coverage and not get the colonoscopy.

“Prior to the policy change, gastroenterologists and their staff had to explain to patients that their insurer would not fully pay for a colonoscopy following a positive noninvasive stool test, and field questions from upset patients who weren’t aware of their insurance plan’s cost-sharing requirements for a cancer screening procedure they thought was free,” Ms. Narramore said.

There’s little doubt the change will help save lives and improve quality of life, Dr. Lieberman said.

“We don’t know the full impact of this new ruling, but we know that financial barriers are important for some patients,” he said. “And so by removing these barriers we hope that we’re going to see improved adherence to follow-up with colonoscopy after a positive stool test, and that would result in reductions in incidence, mortality, and increased life-years gained.”

Ms. Narramore said the changes show the importance of pushing for policy change.

“Our physician advocates were effective in educating policy makers on the need for coverage of the full colorectal cancer screening continuum, and how colorectal cancer needs to be viewed as a program given the various steps necessary for a complete screening,” she said. “These successful efforts demonstrate to our members that advocacy works and that they can be a voice for their patients in improving their access to care.”






 

When the Affordable Care Act was signed in 2010, patients became eligible for coverage of screening examinations, which was good news for gastroenterologists and their patients in the fight to prevent colorectal cancer.

But there was a problem: While noninvasive stool tests – measuring microscopic amounts of blood or key DNA mutations, both tip-offs to increased colorectal cancer risk – were considered a screen, the necessary follow-up colonoscopy was not, leaving patients with expensive copays or other payment responsibility.

That interpretation prompted a years-long effort to have the federal agencies who oversee the health insurance sector reinterpret their policy, which finally changed in May 2022. Medicare, which is not covered by the ACA and is administered by a different agency, announced a change to its policy in July 2022, and the change went into effect in January 2023.

“It’s a major victory for patients, and I couldn’t be more delighted,” said David Lieberman, MD, AGAF, professor of medicine in gastroenterology at Oregon Health & Science University, Portland, and former American Gastroenterological Association president, who participated in the effort.

AGA Regulatory Affairs Director Leslie Narramore said AGA Vice President of Public Policy and Advocacy Kathleen Teixeira worked for 10 years, alongside other GI societies and patient advocacy groups, to close the “colonoscopy loophole.” In 2022, the AGA, Fight Colorectal Cancer, and the American Cancer Society–Cancer Action Network met with White House officials and senior officials with the Department of Health & Human Services about expanding the coverage. They also lobbied to eliminate cost-sharing, another way in which preventive colonoscopy is discouraged.

“The COVID-19 public health emergency highlighted health disparities and barriers to access to care,” said Ms. Narramore, who gave input about the effort along with Ms. Teixeira and AGA Director of Government Affairs Sarah Ankney. “The temporary suspension of elective procedures, including screening colonoscopies, exacerbated the existing low colorectal screening rates and created momentum and willingness in agency officials to create positive change.”

Without coverage of the colonoscopy, patients have needed to cover at least part of the cost of the procedure, which could be $1,000 or more with private insurance, or $100 or more with Medicare, Dr. Lieberman said. So, he noted, unsuspecting patients might receive a positive result on a noninvasive test and have a colonoscopy, only to get a “surprise bill.” Or they would know about the lack of coverage and not get the colonoscopy.

“Prior to the policy change, gastroenterologists and their staff had to explain to patients that their insurer would not fully pay for a colonoscopy following a positive noninvasive stool test, and field questions from upset patients who weren’t aware of their insurance plan’s cost-sharing requirements for a cancer screening procedure they thought was free,” Ms. Narramore said.

There’s little doubt the change will help save lives and improve quality of life, Dr. Lieberman said.

“We don’t know the full impact of this new ruling, but we know that financial barriers are important for some patients,” he said. “And so by removing these barriers we hope that we’re going to see improved adherence to follow-up with colonoscopy after a positive stool test, and that would result in reductions in incidence, mortality, and increased life-years gained.”

Ms. Narramore said the changes show the importance of pushing for policy change.

“Our physician advocates were effective in educating policy makers on the need for coverage of the full colorectal cancer screening continuum, and how colorectal cancer needs to be viewed as a program given the various steps necessary for a complete screening,” she said. “These successful efforts demonstrate to our members that advocacy works and that they can be a voice for their patients in improving their access to care.”






 

ORLANDO – From new tools for diagnosis to new treatment options, the science on wound care continues to advance, providing clinicians with better options for their patients, Hadar Lev-Tov, MD, said at the ODAC Dermatology, Aesthetic & Surgery Conference.

At the meeting, Dr. Lev-Tov, associate professor of dermatology at the University of Miami, reviewed some of the latest developments in several conditions involving wound care.

ORLANDO – From new tools for diagnosis to new treatment options, the science on wound care continues to advance, providing clinicians with better options for their patients, Hadar Lev-Tov, MD, said at the ODAC Dermatology, Aesthetic & Surgery Conference.

At the meeting, Dr. Lev-Tov, associate professor of dermatology at the University of Miami, reviewed some of the latest developments in several conditions involving wound care.

ORLANDO – From new tools for diagnosis to new treatment options, the science on wound care continues to advance, providing clinicians with better options for their patients, Hadar Lev-Tov, MD, said at the ODAC Dermatology, Aesthetic & Surgery Conference.

At the meeting, Dr. Lev-Tov, associate professor of dermatology at the University of Miami, reviewed some of the latest developments in several conditions involving wound care.

ORLANDO – While less frequently seen dermatologic diseases do not get a “ton of attention” in expert talks and discussions, even one to two patients presenting with these conditions a month warrants continuing education, according to Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington.

These semi-forsaken diseases are important not to miss and can “also be quite challenging when we think about their management,” he said at the ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Friedman, also director of the GW dermatology residency program, reviewed several of these diseases – along with tips for management – during a session at the meeting.

Granuloma annulare (GA). This condition, Dr. Friedman said, can have “a lot of faces” – with a localized, general, perforating, subcutaneous, micropapular, or patchy appearance. It does not always have the classic ring pattern for which it is best known, he said. And in patients with darker skin tones, it is characterized by more of a brown or black color, rather than the pink-red color.

Dr. Friedman said that despite a kind of “Pavlovian response” linking GA with diabetes, this link might not be as strong as the field has come to believe, since the studies on which this belief was based included a patient population with narrow demographics. “Maybe GA and type 1 diabetes aren’t necessarily connected,” he said.

Dyslipidemia, on the other hand, has a strong connection with GA, he said. The disease is also linked to thyroid disease and is linked with malignancy, especially in older patients with generalized or atypical presentations of GA, he said.

Spontaneous resolution of the disease is seen within 2 years for 50% to 75% of patients, so “no treatment may be the best treatment,” but antimalarials can be effective, Dr. Friedman said. “I use antimalarials frequently in my practice,” he said. “The key is, they take time to work (4-5 months),” which should be explained to patients.

Antibiotics, he said, can be “somewhat effective,” but in the case of doxycycline at least, the disease can resolve within weeks but then may return when treatment is stopped.

There is some evidence to support using biologics and more recently, Janus kinase (JAK) inhibitors, off-label, to treat GA. Efficacy has been seen with the tumor necrosis factor (TNF) blocker infliximab and with the JAK inhibitor tofacitinib, he said.

 Lichen planus (LP). This is another common disease that can go off-script with its presentation. The disease is often described with the “six P’s” indicating the following characteristics: pruritic, polygonal, planar or flat-topped, purple papules, and plaques. But LP “didn’t read the textbook,” Dr. Friedman said.

“The clinical presentation of lichen planus can be quite broad,” he said. “The P’s aren’t always followed as there are a variety of colors and configurations which can be witnessed.”

With LP, there is a clear association with dyslipidemia and diabetes, so “asking the right questions is going to be important” when talking to the patient. There is also a higher risk of autoimmune diseases, especially of the thyroid type, associated with LP, he said.

No treatment has been Food and Drug Administration approved for LP, but some are expected in the future, he said.

For now, he emphasized creativity in the management of patients with LP. “I love oral retinoids for this,” he said. Antimalarials and methotrexate are also options.

In one case Dr. Friedman saw, nothing seemed to work: light therapy for a year; metronidazole; isotretinoin; halobetasol/tazarotene lotion; and the TNF-blocker adalimumab either weren’t effective or resulted in complications in the patient.

Knowing the recent implication of the interleukin (IL)-17 pathway in the pathophysiology of LP, he then tried the anti-IL17 antibody secukinumab. “This patient had a pretty robust response to treatment,” Dr. Friedman said. “He was very excited. The problem, as always, is access, especially for off-label therapies.”

Tumid lupus erythematosus. This disease is characterized by erythematous, edematous, nonscarring plaques on sun-exposed sites. For treatment, Dr. Friedman said antimalarials can be up to 90% effective, sometimes with rapid resolution of the lesions.

“You want to dose below that 5 mg per kg of true body weight to limit the small potential for ocular toxicity over time,” he said. And, he emphasized, “always combine treatment with good sun-protective measures.”

Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

ORLANDO – While less frequently seen dermatologic diseases do not get a “ton of attention” in expert talks and discussions, even one to two patients presenting with these conditions a month warrants continuing education, according to Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington.

These semi-forsaken diseases are important not to miss and can “also be quite challenging when we think about their management,” he said at the ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Friedman, also director of the GW dermatology residency program, reviewed several of these diseases – along with tips for management – during a session at the meeting.

Granuloma annulare (GA). This condition, Dr. Friedman said, can have “a lot of faces” – with a localized, general, perforating, subcutaneous, micropapular, or patchy appearance. It does not always have the classic ring pattern for which it is best known, he said. And in patients with darker skin tones, it is characterized by more of a brown or black color, rather than the pink-red color.

Dr. Friedman said that despite a kind of “Pavlovian response” linking GA with diabetes, this link might not be as strong as the field has come to believe, since the studies on which this belief was based included a patient population with narrow demographics. “Maybe GA and type 1 diabetes aren’t necessarily connected,” he said.

Dyslipidemia, on the other hand, has a strong connection with GA, he said. The disease is also linked to thyroid disease and is linked with malignancy, especially in older patients with generalized or atypical presentations of GA, he said.

Spontaneous resolution of the disease is seen within 2 years for 50% to 75% of patients, so “no treatment may be the best treatment,” but antimalarials can be effective, Dr. Friedman said. “I use antimalarials frequently in my practice,” he said. “The key is, they take time to work (4-5 months),” which should be explained to patients.

Antibiotics, he said, can be “somewhat effective,” but in the case of doxycycline at least, the disease can resolve within weeks but then may return when treatment is stopped.

There is some evidence to support using biologics and more recently, Janus kinase (JAK) inhibitors, off-label, to treat GA. Efficacy has been seen with the tumor necrosis factor (TNF) blocker infliximab and with the JAK inhibitor tofacitinib, he said.

 Lichen planus (LP). This is another common disease that can go off-script with its presentation. The disease is often described with the “six P’s” indicating the following characteristics: pruritic, polygonal, planar or flat-topped, purple papules, and plaques. But LP “didn’t read the textbook,” Dr. Friedman said.

“The clinical presentation of lichen planus can be quite broad,” he said. “The P’s aren’t always followed as there are a variety of colors and configurations which can be witnessed.”

With LP, there is a clear association with dyslipidemia and diabetes, so “asking the right questions is going to be important” when talking to the patient. There is also a higher risk of autoimmune diseases, especially of the thyroid type, associated with LP, he said.

No treatment has been Food and Drug Administration approved for LP, but some are expected in the future, he said.

For now, he emphasized creativity in the management of patients with LP. “I love oral retinoids for this,” he said. Antimalarials and methotrexate are also options.

In one case Dr. Friedman saw, nothing seemed to work: light therapy for a year; metronidazole; isotretinoin; halobetasol/tazarotene lotion; and the TNF-blocker adalimumab either weren’t effective or resulted in complications in the patient.

Knowing the recent implication of the interleukin (IL)-17 pathway in the pathophysiology of LP, he then tried the anti-IL17 antibody secukinumab. “This patient had a pretty robust response to treatment,” Dr. Friedman said. “He was very excited. The problem, as always, is access, especially for off-label therapies.”

Tumid lupus erythematosus. This disease is characterized by erythematous, edematous, nonscarring plaques on sun-exposed sites. For treatment, Dr. Friedman said antimalarials can be up to 90% effective, sometimes with rapid resolution of the lesions.

“You want to dose below that 5 mg per kg of true body weight to limit the small potential for ocular toxicity over time,” he said. And, he emphasized, “always combine treatment with good sun-protective measures.”

Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

ORLANDO – While less frequently seen dermatologic diseases do not get a “ton of attention” in expert talks and discussions, even one to two patients presenting with these conditions a month warrants continuing education, according to Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington.

These semi-forsaken diseases are important not to miss and can “also be quite challenging when we think about their management,” he said at the ODAC Dermatology, Aesthetic & Surgical Conference.

Dr. Friedman, also director of the GW dermatology residency program, reviewed several of these diseases – along with tips for management – during a session at the meeting.

Granuloma annulare (GA). This condition, Dr. Friedman said, can have “a lot of faces” – with a localized, general, perforating, subcutaneous, micropapular, or patchy appearance. It does not always have the classic ring pattern for which it is best known, he said. And in patients with darker skin tones, it is characterized by more of a brown or black color, rather than the pink-red color.

Dr. Friedman said that despite a kind of “Pavlovian response” linking GA with diabetes, this link might not be as strong as the field has come to believe, since the studies on which this belief was based included a patient population with narrow demographics. “Maybe GA and type 1 diabetes aren’t necessarily connected,” he said.

Dyslipidemia, on the other hand, has a strong connection with GA, he said. The disease is also linked to thyroid disease and is linked with malignancy, especially in older patients with generalized or atypical presentations of GA, he said.

Spontaneous resolution of the disease is seen within 2 years for 50% to 75% of patients, so “no treatment may be the best treatment,” but antimalarials can be effective, Dr. Friedman said. “I use antimalarials frequently in my practice,” he said. “The key is, they take time to work (4-5 months),” which should be explained to patients.

Antibiotics, he said, can be “somewhat effective,” but in the case of doxycycline at least, the disease can resolve within weeks but then may return when treatment is stopped.

There is some evidence to support using biologics and more recently, Janus kinase (JAK) inhibitors, off-label, to treat GA. Efficacy has been seen with the tumor necrosis factor (TNF) blocker infliximab and with the JAK inhibitor tofacitinib, he said.

 Lichen planus (LP). This is another common disease that can go off-script with its presentation. The disease is often described with the “six P’s” indicating the following characteristics: pruritic, polygonal, planar or flat-topped, purple papules, and plaques. But LP “didn’t read the textbook,” Dr. Friedman said.

“The clinical presentation of lichen planus can be quite broad,” he said. “The P’s aren’t always followed as there are a variety of colors and configurations which can be witnessed.”

With LP, there is a clear association with dyslipidemia and diabetes, so “asking the right questions is going to be important” when talking to the patient. There is also a higher risk of autoimmune diseases, especially of the thyroid type, associated with LP, he said.

No treatment has been Food and Drug Administration approved for LP, but some are expected in the future, he said.

For now, he emphasized creativity in the management of patients with LP. “I love oral retinoids for this,” he said. Antimalarials and methotrexate are also options.

In one case Dr. Friedman saw, nothing seemed to work: light therapy for a year; metronidazole; isotretinoin; halobetasol/tazarotene lotion; and the TNF-blocker adalimumab either weren’t effective or resulted in complications in the patient.

Knowing the recent implication of the interleukin (IL)-17 pathway in the pathophysiology of LP, he then tried the anti-IL17 antibody secukinumab. “This patient had a pretty robust response to treatment,” Dr. Friedman said. “He was very excited. The problem, as always, is access, especially for off-label therapies.”

Tumid lupus erythematosus. This disease is characterized by erythematous, edematous, nonscarring plaques on sun-exposed sites. For treatment, Dr. Friedman said antimalarials can be up to 90% effective, sometimes with rapid resolution of the lesions.

“You want to dose below that 5 mg per kg of true body weight to limit the small potential for ocular toxicity over time,” he said. And, he emphasized, “always combine treatment with good sun-protective measures.”

Dr. Friedman reported financial relationships with Sanova, Pfizer, Novartis, and other companies.

ORLANDO – Three weeks after a course of trimethoprim/sulfamethoxazole (Bactrim), a young female patient developed facial edema that involved “dusky erythematous papules” that were itchy. The eruption spread away from the head and her transaminase levels were “dramatic,” in the 700s, said Kalyani S. Marathe, MD, MPH, associate professor of dermatology and pediatrics at the University of Cincinnati.

Dr. Marathe, director of the division of dermatology at Cincinnati Children’s Hospital, reviewed this case in a presentation on pediatric dermatologic emergencies at the ODAC Dermatology, Aesthetic & Surgery Conference, pointing out potential pitfalls and important aspects that might require swift action.

The patient was diagnosed with drug reaction with eosinophilia and systemic symptoms (DRESS).

Facial involvement is common in pediatric cases of DRESS, but edema of the face is less common in children than adults, Dr. Marathe said.

Antiepileptic medications are the most common cause of DRESS, followed by antibiotics – most often, vancomycin and trimethoprim/sulfamethoxazole, she said. But sometimes the trigger is not clear, she noted, recalling a vexing case she once saw in which IV contrast was eventually identified as the cause.

When DRESS is suspected, she said, lab work should be done during the acute eruption and after resolution. This should include CBC, liver function tests, creatinine, and urinalysis, and human herpesvirus 6 (HHV-6) and thyroid testing.

Treatment typically includes supportive care, unless symptoms are systemic, or if there is impending liver failure, when steroids, cyclosporine, or IVIG can be used.

Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): Mortality rates when these diseases overlap is 4%, Dr. Marathe said. Clues to diagnosing this other medication-induced condition include involvement of the palms and the soles of the feet; presence of the Nikolsky sign in which the top layers of the skin slip away from the lower layers when rubbed; mucosal involvement, which often precedes cutaneous involvement; and these symptoms occurring within the first 8 weeks of taking a medication, which are most commonly antibiotics and anti-epileptics.

Dr. Marathe underscored how important it is to get ophthalmology involved right away, because of the risk of vision loss. Amniotic membrane transfer to the eye at the time of diagnosis has been found to produce dramatically better outcomes, she said. The membrane has anti-inflammatory and antiscarring properties and can promote wound healing on the surface of the eye.

“I would recommend getting your ophthalmology team on board early because they have to advocate for these patients,” she said.

Corticosteroids and IVIG can improve ocular outcomes, but cyclosporine is associated with better mortality outcomes, she said. Emerging data on etanercept has also led to more use of that drug, she said.

Erythema multiforme (EM): unlike urticaria, multiforme EM can have mucosal involvement, Dr. Marathe said. Clinicians should look for three zones of color: A central duskiness, a rim of pallor, and a ring of erythema.

EM is triggered by a virus, which is usually herpes simplex virus (HSV). But she added that HSV is not always found. “So, there are certainly other triggers out there that we just haven’t identified,” she said.

If HSV is suspected, oral acyclovir is effective, she noted.

Other cases might not be as straightforward. Dr. Marathe said that during her fellowship, she saw a patient with EM that was controlled only by IVIG, so it was administered every 3 months. In that case, the trigger was never found.

Multisystem inflammatory syndrome in children (MIS-C): This syndrome can follow COVID-19 infection, and usually presents with 3-5 days of fever after COVID has resolved. It can include gastrointestinal, cardiorespiratory, and neurocognitive symptoms.

The skin presentation is mainly a morbilliform pattern, but clinicians might also see conjunctival involvement, mucosal involvement, and “COVID toes,” painful red or purple lesions on the toes.

Treatment is usually IVIG and systemic corticosteroids, with the treatment course depending on the severity.

MIS-C was initially thought to be Kawasaki’s disease, another autoinflammatory disorder, which is related but distinct, Dr. Marathe said.

Patients with MIS-C “are usually going to have COVID-positive antibodies,” she said. But since almost everybody may have COVID antibodies, “it’s not usually a helpful test for you now. But early on, that’s what we used as helpful indicator.”

Dr. Marathe reported no relevant financial relationships.

ORLANDO – Three weeks after a course of trimethoprim/sulfamethoxazole (Bactrim), a young female patient developed facial edema that involved “dusky erythematous papules” that were itchy. The eruption spread away from the head and her transaminase levels were “dramatic,” in the 700s, said Kalyani S. Marathe, MD, MPH, associate professor of dermatology and pediatrics at the University of Cincinnati.

Dr. Marathe, director of the division of dermatology at Cincinnati Children’s Hospital, reviewed this case in a presentation on pediatric dermatologic emergencies at the ODAC Dermatology, Aesthetic & Surgery Conference, pointing out potential pitfalls and important aspects that might require swift action.

The patient was diagnosed with drug reaction with eosinophilia and systemic symptoms (DRESS).

Facial involvement is common in pediatric cases of DRESS, but edema of the face is less common in children than adults, Dr. Marathe said.

Antiepileptic medications are the most common cause of DRESS, followed by antibiotics – most often, vancomycin and trimethoprim/sulfamethoxazole, she said. But sometimes the trigger is not clear, she noted, recalling a vexing case she once saw in which IV contrast was eventually identified as the cause.

When DRESS is suspected, she said, lab work should be done during the acute eruption and after resolution. This should include CBC, liver function tests, creatinine, and urinalysis, and human herpesvirus 6 (HHV-6) and thyroid testing.

Treatment typically includes supportive care, unless symptoms are systemic, or if there is impending liver failure, when steroids, cyclosporine, or IVIG can be used.

Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): Mortality rates when these diseases overlap is 4%, Dr. Marathe said. Clues to diagnosing this other medication-induced condition include involvement of the palms and the soles of the feet; presence of the Nikolsky sign in which the top layers of the skin slip away from the lower layers when rubbed; mucosal involvement, which often precedes cutaneous involvement; and these symptoms occurring within the first 8 weeks of taking a medication, which are most commonly antibiotics and anti-epileptics.

Dr. Marathe underscored how important it is to get ophthalmology involved right away, because of the risk of vision loss. Amniotic membrane transfer to the eye at the time of diagnosis has been found to produce dramatically better outcomes, she said. The membrane has anti-inflammatory and antiscarring properties and can promote wound healing on the surface of the eye.

“I would recommend getting your ophthalmology team on board early because they have to advocate for these patients,” she said.

Corticosteroids and IVIG can improve ocular outcomes, but cyclosporine is associated with better mortality outcomes, she said. Emerging data on etanercept has also led to more use of that drug, she said.

Erythema multiforme (EM): unlike urticaria, multiforme EM can have mucosal involvement, Dr. Marathe said. Clinicians should look for three zones of color: A central duskiness, a rim of pallor, and a ring of erythema.

EM is triggered by a virus, which is usually herpes simplex virus (HSV). But she added that HSV is not always found. “So, there are certainly other triggers out there that we just haven’t identified,” she said.

If HSV is suspected, oral acyclovir is effective, she noted.

Other cases might not be as straightforward. Dr. Marathe said that during her fellowship, she saw a patient with EM that was controlled only by IVIG, so it was administered every 3 months. In that case, the trigger was never found.

Multisystem inflammatory syndrome in children (MIS-C): This syndrome can follow COVID-19 infection, and usually presents with 3-5 days of fever after COVID has resolved. It can include gastrointestinal, cardiorespiratory, and neurocognitive symptoms.

The skin presentation is mainly a morbilliform pattern, but clinicians might also see conjunctival involvement, mucosal involvement, and “COVID toes,” painful red or purple lesions on the toes.

Treatment is usually IVIG and systemic corticosteroids, with the treatment course depending on the severity.

MIS-C was initially thought to be Kawasaki’s disease, another autoinflammatory disorder, which is related but distinct, Dr. Marathe said.

Patients with MIS-C “are usually going to have COVID-positive antibodies,” she said. But since almost everybody may have COVID antibodies, “it’s not usually a helpful test for you now. But early on, that’s what we used as helpful indicator.”

Dr. Marathe reported no relevant financial relationships.

ORLANDO – Three weeks after a course of trimethoprim/sulfamethoxazole (Bactrim), a young female patient developed facial edema that involved “dusky erythematous papules” that were itchy. The eruption spread away from the head and her transaminase levels were “dramatic,” in the 700s, said Kalyani S. Marathe, MD, MPH, associate professor of dermatology and pediatrics at the University of Cincinnati.

Dr. Marathe, director of the division of dermatology at Cincinnati Children’s Hospital, reviewed this case in a presentation on pediatric dermatologic emergencies at the ODAC Dermatology, Aesthetic & Surgery Conference, pointing out potential pitfalls and important aspects that might require swift action.

The patient was diagnosed with drug reaction with eosinophilia and systemic symptoms (DRESS).

Facial involvement is common in pediatric cases of DRESS, but edema of the face is less common in children than adults, Dr. Marathe said.

Antiepileptic medications are the most common cause of DRESS, followed by antibiotics – most often, vancomycin and trimethoprim/sulfamethoxazole, she said. But sometimes the trigger is not clear, she noted, recalling a vexing case she once saw in which IV contrast was eventually identified as the cause.

When DRESS is suspected, she said, lab work should be done during the acute eruption and after resolution. This should include CBC, liver function tests, creatinine, and urinalysis, and human herpesvirus 6 (HHV-6) and thyroid testing.

Treatment typically includes supportive care, unless symptoms are systemic, or if there is impending liver failure, when steroids, cyclosporine, or IVIG can be used.

Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): Mortality rates when these diseases overlap is 4%, Dr. Marathe said. Clues to diagnosing this other medication-induced condition include involvement of the palms and the soles of the feet; presence of the Nikolsky sign in which the top layers of the skin slip away from the lower layers when rubbed; mucosal involvement, which often precedes cutaneous involvement; and these symptoms occurring within the first 8 weeks of taking a medication, which are most commonly antibiotics and anti-epileptics.

Dr. Marathe underscored how important it is to get ophthalmology involved right away, because of the risk of vision loss. Amniotic membrane transfer to the eye at the time of diagnosis has been found to produce dramatically better outcomes, she said. The membrane has anti-inflammatory and antiscarring properties and can promote wound healing on the surface of the eye.

“I would recommend getting your ophthalmology team on board early because they have to advocate for these patients,” she said.

Corticosteroids and IVIG can improve ocular outcomes, but cyclosporine is associated with better mortality outcomes, she said. Emerging data on etanercept has also led to more use of that drug, she said.

Erythema multiforme (EM): unlike urticaria, multiforme EM can have mucosal involvement, Dr. Marathe said. Clinicians should look for three zones of color: A central duskiness, a rim of pallor, and a ring of erythema.

EM is triggered by a virus, which is usually herpes simplex virus (HSV). But she added that HSV is not always found. “So, there are certainly other triggers out there that we just haven’t identified,” she said.

If HSV is suspected, oral acyclovir is effective, she noted.

Other cases might not be as straightforward. Dr. Marathe said that during her fellowship, she saw a patient with EM that was controlled only by IVIG, so it was administered every 3 months. In that case, the trigger was never found.

Multisystem inflammatory syndrome in children (MIS-C): This syndrome can follow COVID-19 infection, and usually presents with 3-5 days of fever after COVID has resolved. It can include gastrointestinal, cardiorespiratory, and neurocognitive symptoms.

The skin presentation is mainly a morbilliform pattern, but clinicians might also see conjunctival involvement, mucosal involvement, and “COVID toes,” painful red or purple lesions on the toes.

Treatment is usually IVIG and systemic corticosteroids, with the treatment course depending on the severity.

MIS-C was initially thought to be Kawasaki’s disease, another autoinflammatory disorder, which is related but distinct, Dr. Marathe said.

Patients with MIS-C “are usually going to have COVID-positive antibodies,” she said. But since almost everybody may have COVID antibodies, “it’s not usually a helpful test for you now. But early on, that’s what we used as helpful indicator.”

Dr. Marathe reported no relevant financial relationships.