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Patients usually understand and agree with physicians’ notes

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Mon, 03/22/2021 - 14:08

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

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Medscape Article

Psoriatic disease inflammation linked to heart failure

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Tue, 02/07/2023 - 16:49

Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar
Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

Dr. Deepak Jadon

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.



The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).

Dr. Diamant Thaçi

The study cohort more closely resembles a rheumatology cohort than a dermatology cohort, and it suggests that patients with psoriatic arthritis have different cardiovascular comorbidities than those with pure psoriasis, according to Diamant Thaçi, MD, PhD, professor and chairman of the department of dermatology at the University of Lübeck (Germany). “It shows how it important it is to look for comorbidity in the rheumatologic setting,” Dr. Thaçi said in an interview.

The study was supported by the Arthritis Society. Dr. Koppikar and Dr. Thaçi have no relevant financial disclosures.

SOURCE: Koppikar S et al. GRAPPA 2020 Virtual Annual Meeting.

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Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar
Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

Dr. Deepak Jadon

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.



The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).

Dr. Diamant Thaçi

The study cohort more closely resembles a rheumatology cohort than a dermatology cohort, and it suggests that patients with psoriatic arthritis have different cardiovascular comorbidities than those with pure psoriasis, according to Diamant Thaçi, MD, PhD, professor and chairman of the department of dermatology at the University of Lübeck (Germany). “It shows how it important it is to look for comorbidity in the rheumatologic setting,” Dr. Thaçi said in an interview.

The study was supported by the Arthritis Society. Dr. Koppikar and Dr. Thaçi have no relevant financial disclosures.

SOURCE: Koppikar S et al. GRAPPA 2020 Virtual Annual Meeting.

Patients with psoriatic disease are known to be at increased risk of heart failure. A new cohort study suggests that part of the risk may be attributable to the disease itself, not just traditional cardiovascular risk factors like obesity and metabolic abnormalities that are common comorbidities in psoriatic disease. There may also be differences in the risk profiles of patients with ischemic and nonischemic heart failure.

Courtesy Dr. Sahil Koppikar
Dr. Sahil Koppikar

Previous studies have shown that heart failure risk in patients with psoriatic arthritis is 32% higher than in the general population, and with psoriasis, it is 22%-53% higher. However, those studies were based on administrative databases with no clinical information to back up the accuracy of diagnoses, Sahil Koppikar, MD, from the University of Toronto, said during a presentation of the research at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The finding that psoriatic disease inflammation may be a direct risk factor for heart failure might be good news for patients. “By controlling inflammation, we may be able to reduce the risk of heart failure in these patients,” Dr. Koppikar said.

Dr. Deepak Jadon

During a question and answer session, discussant Deepak Jadon, MBChB, PhD, director of the rheumatology research unit and lead for psoriatic arthritis at Addenbrooke’s Hospital, Cambridge (England), noted that patients with conditions like lupus and systemic sclerosis may undergo regular echocardiograms, chest CTs, or other surveillance, and asked if Dr. Koppikar could recommend a framework for similar surveillance in psoriatic arthritis.

“With the current data we have, I don’t know if we can make recommendations. What we learned from our study is that patients that have elevated inflammatory disease, with elevated inflammatory markers for a prolonged period of time, were at higher risk than [if they had elevated markers only] just before the event. So poorly controlled patients might be something you should be more aware of, and maybe get cardiology involved. But I don’t think it’s something we should be doing right now for all patients,” Dr. Koppikar said.

The researchers analyzed data from a psoriasis cohort at the University of Toronto that began in 2006. Every 6-12 months, they were assessed by a rheumatologist and underwent imaging assessment and laboratory tests. The primary outcome of the study was the first heart failure event, which the researchers identified by linking the cohort database with provincial hospitalization and mortality databases. They verified all events by examining medical records. They also assessed the association between heart failure and disease activity over time rather than just before the event.



The analysis included 1,994 patients. A total of 64 new heart failure events occurred during a mean follow-up of 11.3 years (2.85 per 1,000 person-years), including 38 ischemic and 26 nonischemic events. A multivariate analysis found that heart failure was associated with adjusted mean (AM) tender joint count (hazard ratio, 1.51; P = .02), AM swollen joint count (HR, 1.82; P = .04), AM erythrocyte sedimentation rate (HR, 1.26; P = .009), AM C-reactive protein (HR, 1.27; P = .001), Health Assessment Questionnaire (HR, 1.95; P = .001), and minimum disease activity state (HR, 0.40; P = .04). The multivariate analysis was adjusted for sex, hypertension, diabetes mellitus, body mass index, ischemic heart disease, lipids, and smoking status.

When the researchers separated the analysis into ischemic and nonischemic heart failure, some interesting associations popped out. Nonischemic heart failure was associated with AM tender joint count (HR, 1.83; P = .004), but ischemic heart failure was not. Other factors associated with nonischemic but not ischemic heart failure included AM swollen joint count (HR, 3.56; P = .0003), damaged joint count (HR, 1.29; P = .04), and pain score (HR, 1.22; P = .047). Minimum disease activity had the opposite result: It was associated with only ischemic heart failure (HR, 0.40; P = .04).

Dr. Diamant Thaçi

The study cohort more closely resembles a rheumatology cohort than a dermatology cohort, and it suggests that patients with psoriatic arthritis have different cardiovascular comorbidities than those with pure psoriasis, according to Diamant Thaçi, MD, PhD, professor and chairman of the department of dermatology at the University of Lübeck (Germany). “It shows how it important it is to look for comorbidity in the rheumatologic setting,” Dr. Thaçi said in an interview.

The study was supported by the Arthritis Society. Dr. Koppikar and Dr. Thaçi have no relevant financial disclosures.

SOURCE: Koppikar S et al. GRAPPA 2020 Virtual Annual Meeting.

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FROM GRAPPA 2020 VIRTUAL ANNUAL MEETING

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Doctors hesitated to embrace biosimilar infliximab in first 2 years

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Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.



Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

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Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.



Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

Physicians have been slow to embrace biosimilar versions of infliximab, but are more likely to prescribe it to new patients, based on data from a review of nearly 50,000 infliximab claims through Medicare in the first 2 years that biosimilars were available in the United States.

“Although biosimilar versions are as safe and effective as the biologic, patients and physicians may be more reluctant to switch from a working biologic regimen in a chronic setting than an acute one,” wrote Alice J. Chen, PhD, of the University of Southern California, Los Angeles, and colleagues.

In a research letter published in JAMA Internal Medicine, the investigators examined prescribing patterns of physicians switching between the originator infliximab (Remicade) and two of its biosimilars (Inflectra and Renflexis).

They reviewed infliximab use and reimbursement in the 100% Medicare Part B quarterly claims database from Jan. 1, 2017, to Dec. 31, 2018. The study population included Medicare patients classified as new if they had no infliximab claims in the prior 6 months; those with claims were considered returning patients.

In a comparison of claims reflecting 49,771 patients and 4,289 physicians in 2018, a total of 1,418 new patients (17.4%) and 4,495 (10.8%) returning patients used a biosimilar. “Of returning patients, half used the biosimilar version exclusively, whereas the other half switched between biologic and biosimilar versions,” the researchers noted.



Of the 4,289 physicians who prescribed infliximab, 3,124 prescribed no biosimilars, 1,015 prescribed both biologics and biosimilars, and 150 prescribed biosimilars only. Of the physicians who prescribed both, approximately 61% switched some patients from the biologic to the biosimilar; “the remainder kept individual patients on only 1 version of the drug but treated patients with both versions,” the researchers wrote.

The adoption of biosimilars may be slower for chronic vs. acute conditions, the researchers noted. “Prescribers may hesitate to switch clinically stable chronic patients from biologic regimens if they are unfamiliar with the biosimilar or face financial disincentives from prescribing it.”

The study findings were limited by several factors including the use of only 2 years of data and a focus only on Medicare Part B. Switching medications may have been influenced by factors such as lower copays for patients and rebates or discounts for physicians; however, “further research is needed to better understand biosimilar pricing dynamics and the barriers to adopting biosimilars for chronic conditions,” they concluded.

The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

SOURCE: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

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Key clinical point: A total of 17% of patients new to infliximab received a biosimilar in 2018, compared with 11% of returning patients.

Major finding: Biosimilar infliximab accounted for 10% of the market share 2 years after the product was introduced.

Study details: The data come from a review of infliximab claims across 49,771 patients and 4,289 physicians who prescribed infliximab in 2018.

Disclosures: The study was supported by the Leonard D. Schaeffer Center for Health Policy & Economics at the University of Southern California, Los Angeles, and the National Institute on Aging. Lead author Dr. Chen also disclosed receiving personal fees from Amgen outside of the current study.

Source: Chen AJ et al. JAMA Intern Med. 2020 July 20. doi: 10.1001/jamainternmed.2020.3188.

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Colorism and dermatology

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Mon, 07/20/2020 - 10:44

With the world currently really listening and engaged (hopefully) on making positive changes with regards to racism and systemic racial injustices, skin color has come to the forefront. Racism because of skin color has been an unfortunate part of our history and foundation of the United States with a capitalist society built and thriving on the profits of slavery, and a democracy founded on equality – unless you had black skin. These issues are at the forefront in the United States, but have also significantly impacted other parts of the world, including the Caribbean and South America having a significant African slave trade history and impacts, with Brazil currently facing the same systemic racial injustices and police brutality among black men, and King Leopold II of Belgium slaughtering an estimated 10-15 million Congolese people in the name of colonialism, slavery, and robbing resources (natural resources as well as servitude) in the Congo as late as the early 1900s.

Dr. Naissan O. Wesley

These are just a few of the many historical examples of racial injustice, which remains ingrained in many parts of our society today. With this worldwide history, it has been advantageous for people to have lighter skin with regards to money, politics, jobs, education, the justice system, modeling/acting opportunities and contracts, home ownership, and opportunities for generational wealth for years to come. It has ingrained some unfortunate beliefs among some that having lighter skin is better, advantageous, and will make them more desirable or more beautiful.

Colorism, its social impact, and consequences on the beauty industry with skin-whitening products is evident all over the world, particularly parts of Asia (especially South Korea and China), India, and across the African continent. It is estimated that 77% of women in Nigeria and 55% of women in China use bleaching creams to achieve overall skin lightening. Unilever’s Fair & Lovely skin-whitening cream has long been a popular over-the-counter product in India, with an estimated market worth of 270 billion rupees ($4 billion USD). On June 25, 2020, Unilever vowed to rename and rebrand Fair & Lovely. With such an offensive name for a product that further promotes colorism, this is an effort in the right direction and has been a long time coming since its debut in 1975. Unilever’s Fair and Lovely Foundation for women’s causes still exists, and has not been renamed at the time of this writing.



Controversy remains on whether this product and other products such as these should exist for the purposes they are used for. Johnson & Johnson has decided that it will no longer produce and sell the Neutrogena Fine Fairness line, sold only in Asia and the Middle East, and the Clean & Clear Fairness line, sold in India. There are arguments to the contrary that halting production of skin-lightening products altogether may result in an influx of unsafe alternatives.

As dermatologists, we use skin-lightening products appropriately for the purposes of treating skin conditions such as postinflammatory hyperpigmentation, melasma, and photoaging. This is where the use of such products should largely end. While it is up to individuals about what they do with their skin and their bodies, we, as health care skin professionals, should be furthering the notion that all skin colors and types are beautiful. Moreover, we should not be encouraging the use of these products for overall skin whitening. Part of the issue is that these products are available often at high concentrations over the counter or in the illegal market, especially in parts of Asia and Africa where colorism is more common and skin whitening is more commonly practiced. The dangers are not only the risk of ochronosis with high concentrations or long term use of hydroquinone, but also what the Centre for Science and Environment found in a 2014 study, that 44% of the skin “fairness” creams in India contained mercury, which is illegal and a health concern.

Dr. Lily Talakoub

In my practice, I have also had patients (several originally from Nigeria) who have admitted to long term use of skin-bleaching products for the purposes of all over face- and body-skin lightening who now suffer from very sensitive skin and experience bouts of eczematous dermatitis from time to time, despite having stopped using lightening cream. While there are adverse physical effects resulting from the use of these topicals for this purpose, the effects on the psyche are what concern me the most.

The beauty industry has also been an unfortunate part of furthering thoughts and attitudes concerning colorism over the years with lighter skin and Caucasian ideals being set as standards of beauty. One of many examples is a deodorant ad in the Middle East with the tagline “White is Purity” on a woman, which was pulled by Nivea in 2017 after it was slammed as racist. Another is the 2017 Dove ad for body wash that showed a smiling black woman peel off her brown shirt to reveal a white woman in a lighter-color shirt.

A shift has occurred in recent years with more ethnic images of beauty appearing in magazines and film. However, such opportunities are still less plentiful, pay discrepancies still occur, and sexual objectification of women of color as opposed to beautification is still rampant. As such, it is also up to us to do our part in studying and utilizing ethnic and racial differences in skin and beauty to maximize our efforts in promoting what is inherently beautiful as opposed to one standard of beauty. The education begins with the images we see, what we teach our children, loving ourselves, and as doctors, being knowledgeable about the right aesthetic choices for patients with different skin colors and types.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

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With the world currently really listening and engaged (hopefully) on making positive changes with regards to racism and systemic racial injustices, skin color has come to the forefront. Racism because of skin color has been an unfortunate part of our history and foundation of the United States with a capitalist society built and thriving on the profits of slavery, and a democracy founded on equality – unless you had black skin. These issues are at the forefront in the United States, but have also significantly impacted other parts of the world, including the Caribbean and South America having a significant African slave trade history and impacts, with Brazil currently facing the same systemic racial injustices and police brutality among black men, and King Leopold II of Belgium slaughtering an estimated 10-15 million Congolese people in the name of colonialism, slavery, and robbing resources (natural resources as well as servitude) in the Congo as late as the early 1900s.

Dr. Naissan O. Wesley

These are just a few of the many historical examples of racial injustice, which remains ingrained in many parts of our society today. With this worldwide history, it has been advantageous for people to have lighter skin with regards to money, politics, jobs, education, the justice system, modeling/acting opportunities and contracts, home ownership, and opportunities for generational wealth for years to come. It has ingrained some unfortunate beliefs among some that having lighter skin is better, advantageous, and will make them more desirable or more beautiful.

Colorism, its social impact, and consequences on the beauty industry with skin-whitening products is evident all over the world, particularly parts of Asia (especially South Korea and China), India, and across the African continent. It is estimated that 77% of women in Nigeria and 55% of women in China use bleaching creams to achieve overall skin lightening. Unilever’s Fair & Lovely skin-whitening cream has long been a popular over-the-counter product in India, with an estimated market worth of 270 billion rupees ($4 billion USD). On June 25, 2020, Unilever vowed to rename and rebrand Fair & Lovely. With such an offensive name for a product that further promotes colorism, this is an effort in the right direction and has been a long time coming since its debut in 1975. Unilever’s Fair and Lovely Foundation for women’s causes still exists, and has not been renamed at the time of this writing.



Controversy remains on whether this product and other products such as these should exist for the purposes they are used for. Johnson & Johnson has decided that it will no longer produce and sell the Neutrogena Fine Fairness line, sold only in Asia and the Middle East, and the Clean & Clear Fairness line, sold in India. There are arguments to the contrary that halting production of skin-lightening products altogether may result in an influx of unsafe alternatives.

As dermatologists, we use skin-lightening products appropriately for the purposes of treating skin conditions such as postinflammatory hyperpigmentation, melasma, and photoaging. This is where the use of such products should largely end. While it is up to individuals about what they do with their skin and their bodies, we, as health care skin professionals, should be furthering the notion that all skin colors and types are beautiful. Moreover, we should not be encouraging the use of these products for overall skin whitening. Part of the issue is that these products are available often at high concentrations over the counter or in the illegal market, especially in parts of Asia and Africa where colorism is more common and skin whitening is more commonly practiced. The dangers are not only the risk of ochronosis with high concentrations or long term use of hydroquinone, but also what the Centre for Science and Environment found in a 2014 study, that 44% of the skin “fairness” creams in India contained mercury, which is illegal and a health concern.

Dr. Lily Talakoub

In my practice, I have also had patients (several originally from Nigeria) who have admitted to long term use of skin-bleaching products for the purposes of all over face- and body-skin lightening who now suffer from very sensitive skin and experience bouts of eczematous dermatitis from time to time, despite having stopped using lightening cream. While there are adverse physical effects resulting from the use of these topicals for this purpose, the effects on the psyche are what concern me the most.

The beauty industry has also been an unfortunate part of furthering thoughts and attitudes concerning colorism over the years with lighter skin and Caucasian ideals being set as standards of beauty. One of many examples is a deodorant ad in the Middle East with the tagline “White is Purity” on a woman, which was pulled by Nivea in 2017 after it was slammed as racist. Another is the 2017 Dove ad for body wash that showed a smiling black woman peel off her brown shirt to reveal a white woman in a lighter-color shirt.

A shift has occurred in recent years with more ethnic images of beauty appearing in magazines and film. However, such opportunities are still less plentiful, pay discrepancies still occur, and sexual objectification of women of color as opposed to beautification is still rampant. As such, it is also up to us to do our part in studying and utilizing ethnic and racial differences in skin and beauty to maximize our efforts in promoting what is inherently beautiful as opposed to one standard of beauty. The education begins with the images we see, what we teach our children, loving ourselves, and as doctors, being knowledgeable about the right aesthetic choices for patients with different skin colors and types.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

With the world currently really listening and engaged (hopefully) on making positive changes with regards to racism and systemic racial injustices, skin color has come to the forefront. Racism because of skin color has been an unfortunate part of our history and foundation of the United States with a capitalist society built and thriving on the profits of slavery, and a democracy founded on equality – unless you had black skin. These issues are at the forefront in the United States, but have also significantly impacted other parts of the world, including the Caribbean and South America having a significant African slave trade history and impacts, with Brazil currently facing the same systemic racial injustices and police brutality among black men, and King Leopold II of Belgium slaughtering an estimated 10-15 million Congolese people in the name of colonialism, slavery, and robbing resources (natural resources as well as servitude) in the Congo as late as the early 1900s.

Dr. Naissan O. Wesley

These are just a few of the many historical examples of racial injustice, which remains ingrained in many parts of our society today. With this worldwide history, it has been advantageous for people to have lighter skin with regards to money, politics, jobs, education, the justice system, modeling/acting opportunities and contracts, home ownership, and opportunities for generational wealth for years to come. It has ingrained some unfortunate beliefs among some that having lighter skin is better, advantageous, and will make them more desirable or more beautiful.

Colorism, its social impact, and consequences on the beauty industry with skin-whitening products is evident all over the world, particularly parts of Asia (especially South Korea and China), India, and across the African continent. It is estimated that 77% of women in Nigeria and 55% of women in China use bleaching creams to achieve overall skin lightening. Unilever’s Fair & Lovely skin-whitening cream has long been a popular over-the-counter product in India, with an estimated market worth of 270 billion rupees ($4 billion USD). On June 25, 2020, Unilever vowed to rename and rebrand Fair & Lovely. With such an offensive name for a product that further promotes colorism, this is an effort in the right direction and has been a long time coming since its debut in 1975. Unilever’s Fair and Lovely Foundation for women’s causes still exists, and has not been renamed at the time of this writing.



Controversy remains on whether this product and other products such as these should exist for the purposes they are used for. Johnson & Johnson has decided that it will no longer produce and sell the Neutrogena Fine Fairness line, sold only in Asia and the Middle East, and the Clean & Clear Fairness line, sold in India. There are arguments to the contrary that halting production of skin-lightening products altogether may result in an influx of unsafe alternatives.

As dermatologists, we use skin-lightening products appropriately for the purposes of treating skin conditions such as postinflammatory hyperpigmentation, melasma, and photoaging. This is where the use of such products should largely end. While it is up to individuals about what they do with their skin and their bodies, we, as health care skin professionals, should be furthering the notion that all skin colors and types are beautiful. Moreover, we should not be encouraging the use of these products for overall skin whitening. Part of the issue is that these products are available often at high concentrations over the counter or in the illegal market, especially in parts of Asia and Africa where colorism is more common and skin whitening is more commonly practiced. The dangers are not only the risk of ochronosis with high concentrations or long term use of hydroquinone, but also what the Centre for Science and Environment found in a 2014 study, that 44% of the skin “fairness” creams in India contained mercury, which is illegal and a health concern.

Dr. Lily Talakoub

In my practice, I have also had patients (several originally from Nigeria) who have admitted to long term use of skin-bleaching products for the purposes of all over face- and body-skin lightening who now suffer from very sensitive skin and experience bouts of eczematous dermatitis from time to time, despite having stopped using lightening cream. While there are adverse physical effects resulting from the use of these topicals for this purpose, the effects on the psyche are what concern me the most.

The beauty industry has also been an unfortunate part of furthering thoughts and attitudes concerning colorism over the years with lighter skin and Caucasian ideals being set as standards of beauty. One of many examples is a deodorant ad in the Middle East with the tagline “White is Purity” on a woman, which was pulled by Nivea in 2017 after it was slammed as racist. Another is the 2017 Dove ad for body wash that showed a smiling black woman peel off her brown shirt to reveal a white woman in a lighter-color shirt.

A shift has occurred in recent years with more ethnic images of beauty appearing in magazines and film. However, such opportunities are still less plentiful, pay discrepancies still occur, and sexual objectification of women of color as opposed to beautification is still rampant. As such, it is also up to us to do our part in studying and utilizing ethnic and racial differences in skin and beauty to maximize our efforts in promoting what is inherently beautiful as opposed to one standard of beauty. The education begins with the images we see, what we teach our children, loving ourselves, and as doctors, being knowledgeable about the right aesthetic choices for patients with different skin colors and types.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

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Schools can reopen safely with precautions, experts say

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Thu, 08/26/2021 - 16:03

The absence of in-person school has harmed children in ways beyond loss of academic learning, according to Josh Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore. In addition to learning, school is a place where many children receive breakfast and lunch every day, as well as support services and the benefits of being in a safe and secure environment, Dr. Sharfstein said in a press briefing sponsored by Johns Hopkins University.

However, although it is an important priority for children to return to school, “we are in the midst of a pandemic that poses real risk,” he said.

In the press briefing, several experts shared ideas and considerations for safely reopening K-12 schools in the fall of 2020.

Data from other countries where schools have reopened, notably Austria and Denmark, have been reassuring about the lack of transmission of SARS-CoV-2 among children in a school setting, said Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins Center for Health Security. However, other countries where schools have reopened successfully have reported low levels of viral transmission locally, and a responsible strategy for school reopening in the United States should follow a similar plan, she said. In areas where transmission and infection rates are increasing “it may not be safe to reopen,” but in areas where rates are declining or stable, schools could potentially reopen if they follow safety measures.

Dr. Nuzzo suggested that schools should prioritize students who will benefit most from in-person learning, such as younger children and those with special needs. Considerations include protocols for handwashing and sanitation, and maintaining physical distance by creative use of outdoor classrooms (weather permitting) or other spaces within school buildings. Transportation to and from school also will be an issue to address, she noted.

None of the strategies being considered will completely eliminate risk of SARS-CoV-2 infection in school settings, so allowing parents and students to opt out and choose distance learning will be important as well, said Dr. Nuzzo. In addition, schools may need to consider alternative roles for teachers and staff who don’t feel comfortable being in contact with students and fellow staff members. “All of these things are going to be hard,” Dr. Nuzzo acknowledged. “Hard should not be a deterrent,” to reopening schools, but “we acknowledge the resources that schools will need in order to do this.”

At present, all 50 states and the District of Columbia have released some type of plan for reopening schools, said Megan Collins, MD, MPH, codirector the Johns Hopkins Consortium for School-Based Health Solutions.

Dr. Collins and colleagues have developed a school reopening tracker, which is “a national snapshot of current reopening plans that have been released,” she said. The tracker is being updated continuously as plans evolve. The eSchool+ K-12 School Reopening Tracker identifies 12 reopening categories that states could potentially address in the plans. These categories are divided into Operational and Ethics/Equity. The operational categories include:

  • Core academics
  • SARS-CoV-2 protection
  • Before and after school programs
  • School access and transportation
  • Student health services
  • Food and nutrition.

Ethics/equity categories include the following:

  • Parent choice
  • Teacher and staff choice
  • Children of poverty and systemic disadvantage
  • Children with special needs/English as second language/gifted and twice exceptional
  • Privacy
  • Engagement and transparency.

As of July 15, 2020, 16 states (Arizona, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin) had addressed all 12 categories in their reopening plans, Dr. Collins said.

School reopening plans must take equity issues into account, said Annette Anderson, PhD, of the Johns Hopkins University School of Education.

Specifically, developing learning plans for special education students and others at the most risk for learning loss will be essential. “The digital divide has become a digital canyon” in some areas, Dr. Anderson noted, and schools need to rethink eligibility and work to provide access to devices for online learning for all students.

In addition, schools need to convince parents that schools are safe. She recommended that schools consider inviting parents and families to visit buildings in advance of reopening so they can see the safety measures, such as space between desks, cleaning stations, and other protective strategies.

The message to pediatricians and health care professionals when counseling families about returning individual children to school is to consider the risk to the child and the family directly in the context of the local plans, Dr. Sharfstein said during a question and answer session. “One school system’s plan is one school system’s plan,” he said, and added that families who are concerned about the risk should have an online option. However, “if you see a thoughtful approach” to reopening, with safety steps taken and parents informed, with protocols such as keeping small groups of children together to reduce transmission, “it is a pretty good trade-off,” and that is why the American Academy of Pediatrics currently favors children returning to school, he said.

The briefing participants had no relevant financial conflicts to disclose.

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The absence of in-person school has harmed children in ways beyond loss of academic learning, according to Josh Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore. In addition to learning, school is a place where many children receive breakfast and lunch every day, as well as support services and the benefits of being in a safe and secure environment, Dr. Sharfstein said in a press briefing sponsored by Johns Hopkins University.

However, although it is an important priority for children to return to school, “we are in the midst of a pandemic that poses real risk,” he said.

In the press briefing, several experts shared ideas and considerations for safely reopening K-12 schools in the fall of 2020.

Data from other countries where schools have reopened, notably Austria and Denmark, have been reassuring about the lack of transmission of SARS-CoV-2 among children in a school setting, said Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins Center for Health Security. However, other countries where schools have reopened successfully have reported low levels of viral transmission locally, and a responsible strategy for school reopening in the United States should follow a similar plan, she said. In areas where transmission and infection rates are increasing “it may not be safe to reopen,” but in areas where rates are declining or stable, schools could potentially reopen if they follow safety measures.

Dr. Nuzzo suggested that schools should prioritize students who will benefit most from in-person learning, such as younger children and those with special needs. Considerations include protocols for handwashing and sanitation, and maintaining physical distance by creative use of outdoor classrooms (weather permitting) or other spaces within school buildings. Transportation to and from school also will be an issue to address, she noted.

None of the strategies being considered will completely eliminate risk of SARS-CoV-2 infection in school settings, so allowing parents and students to opt out and choose distance learning will be important as well, said Dr. Nuzzo. In addition, schools may need to consider alternative roles for teachers and staff who don’t feel comfortable being in contact with students and fellow staff members. “All of these things are going to be hard,” Dr. Nuzzo acknowledged. “Hard should not be a deterrent,” to reopening schools, but “we acknowledge the resources that schools will need in order to do this.”

At present, all 50 states and the District of Columbia have released some type of plan for reopening schools, said Megan Collins, MD, MPH, codirector the Johns Hopkins Consortium for School-Based Health Solutions.

Dr. Collins and colleagues have developed a school reopening tracker, which is “a national snapshot of current reopening plans that have been released,” she said. The tracker is being updated continuously as plans evolve. The eSchool+ K-12 School Reopening Tracker identifies 12 reopening categories that states could potentially address in the plans. These categories are divided into Operational and Ethics/Equity. The operational categories include:

  • Core academics
  • SARS-CoV-2 protection
  • Before and after school programs
  • School access and transportation
  • Student health services
  • Food and nutrition.

Ethics/equity categories include the following:

  • Parent choice
  • Teacher and staff choice
  • Children of poverty and systemic disadvantage
  • Children with special needs/English as second language/gifted and twice exceptional
  • Privacy
  • Engagement and transparency.

As of July 15, 2020, 16 states (Arizona, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin) had addressed all 12 categories in their reopening plans, Dr. Collins said.

School reopening plans must take equity issues into account, said Annette Anderson, PhD, of the Johns Hopkins University School of Education.

Specifically, developing learning plans for special education students and others at the most risk for learning loss will be essential. “The digital divide has become a digital canyon” in some areas, Dr. Anderson noted, and schools need to rethink eligibility and work to provide access to devices for online learning for all students.

In addition, schools need to convince parents that schools are safe. She recommended that schools consider inviting parents and families to visit buildings in advance of reopening so they can see the safety measures, such as space between desks, cleaning stations, and other protective strategies.

The message to pediatricians and health care professionals when counseling families about returning individual children to school is to consider the risk to the child and the family directly in the context of the local plans, Dr. Sharfstein said during a question and answer session. “One school system’s plan is one school system’s plan,” he said, and added that families who are concerned about the risk should have an online option. However, “if you see a thoughtful approach” to reopening, with safety steps taken and parents informed, with protocols such as keeping small groups of children together to reduce transmission, “it is a pretty good trade-off,” and that is why the American Academy of Pediatrics currently favors children returning to school, he said.

The briefing participants had no relevant financial conflicts to disclose.

The absence of in-person school has harmed children in ways beyond loss of academic learning, according to Josh Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, Baltimore. In addition to learning, school is a place where many children receive breakfast and lunch every day, as well as support services and the benefits of being in a safe and secure environment, Dr. Sharfstein said in a press briefing sponsored by Johns Hopkins University.

However, although it is an important priority for children to return to school, “we are in the midst of a pandemic that poses real risk,” he said.

In the press briefing, several experts shared ideas and considerations for safely reopening K-12 schools in the fall of 2020.

Data from other countries where schools have reopened, notably Austria and Denmark, have been reassuring about the lack of transmission of SARS-CoV-2 among children in a school setting, said Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins Center for Health Security. However, other countries where schools have reopened successfully have reported low levels of viral transmission locally, and a responsible strategy for school reopening in the United States should follow a similar plan, she said. In areas where transmission and infection rates are increasing “it may not be safe to reopen,” but in areas where rates are declining or stable, schools could potentially reopen if they follow safety measures.

Dr. Nuzzo suggested that schools should prioritize students who will benefit most from in-person learning, such as younger children and those with special needs. Considerations include protocols for handwashing and sanitation, and maintaining physical distance by creative use of outdoor classrooms (weather permitting) or other spaces within school buildings. Transportation to and from school also will be an issue to address, she noted.

None of the strategies being considered will completely eliminate risk of SARS-CoV-2 infection in school settings, so allowing parents and students to opt out and choose distance learning will be important as well, said Dr. Nuzzo. In addition, schools may need to consider alternative roles for teachers and staff who don’t feel comfortable being in contact with students and fellow staff members. “All of these things are going to be hard,” Dr. Nuzzo acknowledged. “Hard should not be a deterrent,” to reopening schools, but “we acknowledge the resources that schools will need in order to do this.”

At present, all 50 states and the District of Columbia have released some type of plan for reopening schools, said Megan Collins, MD, MPH, codirector the Johns Hopkins Consortium for School-Based Health Solutions.

Dr. Collins and colleagues have developed a school reopening tracker, which is “a national snapshot of current reopening plans that have been released,” she said. The tracker is being updated continuously as plans evolve. The eSchool+ K-12 School Reopening Tracker identifies 12 reopening categories that states could potentially address in the plans. These categories are divided into Operational and Ethics/Equity. The operational categories include:

  • Core academics
  • SARS-CoV-2 protection
  • Before and after school programs
  • School access and transportation
  • Student health services
  • Food and nutrition.

Ethics/equity categories include the following:

  • Parent choice
  • Teacher and staff choice
  • Children of poverty and systemic disadvantage
  • Children with special needs/English as second language/gifted and twice exceptional
  • Privacy
  • Engagement and transparency.

As of July 15, 2020, 16 states (Arizona, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, North Carolina, North Dakota, Ohio, Rhode Island, Tennessee, Texas, Virginia, Washington, and Wisconsin) had addressed all 12 categories in their reopening plans, Dr. Collins said.

School reopening plans must take equity issues into account, said Annette Anderson, PhD, of the Johns Hopkins University School of Education.

Specifically, developing learning plans for special education students and others at the most risk for learning loss will be essential. “The digital divide has become a digital canyon” in some areas, Dr. Anderson noted, and schools need to rethink eligibility and work to provide access to devices for online learning for all students.

In addition, schools need to convince parents that schools are safe. She recommended that schools consider inviting parents and families to visit buildings in advance of reopening so they can see the safety measures, such as space between desks, cleaning stations, and other protective strategies.

The message to pediatricians and health care professionals when counseling families about returning individual children to school is to consider the risk to the child and the family directly in the context of the local plans, Dr. Sharfstein said during a question and answer session. “One school system’s plan is one school system’s plan,” he said, and added that families who are concerned about the risk should have an online option. However, “if you see a thoughtful approach” to reopening, with safety steps taken and parents informed, with protocols such as keeping small groups of children together to reduce transmission, “it is a pretty good trade-off,” and that is why the American Academy of Pediatrics currently favors children returning to school, he said.

The briefing participants had no relevant financial conflicts to disclose.

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Clinicians address psoriatic disease risk in the era of COVID-19

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Tue, 02/07/2023 - 16:49

COVID-19 has posed serious questions for patients with psoriatic disease and the clinicians who treat them. Both have serious concerns over whether psoriasis or the medications used to treat it pose additional risk for contracting COVID-19 or experiencing worse outcomes with illness.

At the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, experts gathered to discuss these concerns and what is known about the special risk factors for psoriatic disease patients.

Dr. Kevin Winthrop

Studies from a few registries have been done already among patients with autoimmune disease, and the results so far suggest that patients may be able to breathe a little easier. “I don’t see any data that suggests that use of immunosuppressives or having autoimmune disease increases your risk of acquiring it. I think most of the risk is driven by risk of exposure,” said Kevin Winthrop, MD, MPH, a professor of public health, infectious diseases, ophthalmology at Oregon Health & Science University, Portland, during a presentation.

That assertion was reinforced by data presented by Rebecca Haberman, MD, a rheumatologist at New York University Langone Health. Her group created the Web-Based Assessment of Autoimmune, Immune-Mediated, and Rheumatic Patients during the COVID-19 Pandemic (WARCOV) cohort study to address the question of whether patients with immune-mediated inflammatory disease (IMID), including inflammatory arthritis, psoriasis, or inflammatory bowel disease, should discontinue or modify their immunotherapy regimens in the face of potential exposure to COVID-19.



To date, the study has data on 1,122 patients; 604 with inflammatory arthritis, 128 of whom have tested positive for COVID-19. The team established a cohort using the first 86 IMID patients confirmed to have contracted COVID-19. The hospitalization rate was 16% overall, and use of corticosteroids was associated with increased hospitalization risk. A follow-up analysis looking at the first 103 inflammatory arthritis patients who contracted COVID-19 showed a hospitalization rate of 26% and a mortality of 4%. That hospitalization rate is similar to the general hospitalization rate estimated by the New York Department of Health, Dr. Haberman said in her presentation.

Risk factors associated with hospitalization included being older and having asthma or COPD, which is similar to the general population. Use of oral glucocorticoids was linked to a big increase in risk for hospitalization, even with doses less than 10 mg prednisone daily (odds ratio, 14.31; 95% confidence interval, 3.55-57.70). There were no links between use of any cytokine therapy and risk, but use of TNF inhibitors was associated with a reduced risk (OR, 0.35; 95% CI, 0.13-0.97), while use of JAK inhibitors was associated with greater risk (OR, 6.30; 95% CI, 1.68-23.69). The latter result is tentative because of a small sample size, and it was driven largely by the experiences of patients with psoriatic arthritis.

Dr. Leonard Calabrese

Another study, run by the COVID-19 Global Rheumatology Alliance, looked at 600 patients with rheumatic disease from 40 countries, and “found no smoking gun,” said Leonard Calabrese, DO, who leads the Cleveland Clinic’s section of clinical immunology, during his presentation. “People can develop this when they’re on hydroxychloroquine. They seem to do not remarkably bad or remarkably good. There is no adverse signal for biologics, but being on prednisone [at a dose of] more than 10 mg is not great,” said Dr. Calabrese, who also noted that other publications have supported these conclusions.

So given these findings, how should clinicians address patient concerns? In the absence of probable exposure, “we say it’s better to have a well-controlled IMID on therapy than a poorly-controlled IMID on submaximal therapy. We say stick to therapy and try to wean the prednisone down as low as possible,” Dr. Calabrese said.

More controversially, what should patients do if they have had a significant exposure, such as a close proximity, prolonged exposure encounter with an individual with documented COVID-19, or at high-risk of disease? Dr. Calabrese noted that the American College of Rheumatology (ACR) guidelines recommend that low-level immunomodulation can be continued, “with an asterisk if it’s hydroxychloroquine, and it is in most of our minds now that we know that it is not effective, and the toxicity in the COVID setting is still being worked out,” he said.

With respect to other immunosuppressants, the ACR recommends stopping them temporarily, although IL-6 inhibitors may be continued in select circumstances. Resumption of the therapeutics can resume after a negative COVID test or completion of a 2-week observation period.

When patients contract COVID-19, antimalarial medications can be continued because they have been studied. “But medium-level immunomodulators, in particular methotrexate, I have grave concerns about because it can inhibit the adaptive immune response and antibody formation,” he said. COVID-19 is a serious infection, and all serious biologics have a package insert saying to stop them in a serious infection. Again, IL-6 inhibitors may be considered an exception in the right circumstances. When to resume these medications remains unknown. “I think that’s a work in progress. Test-based versus clinic-based strategies are a matter of controversy,” Dr. Calabrese said.

Dr. Kristina Duffin

Ultimately, the question of what to do with immunosuppressive therapies in this population will continue to be a challenge. “The only good answer is to follow the rules of social distancing and to wear a mask,” said Kristina Callis Duffin, MD, a cochair of the department of dermatology and associate professor of dermatology at the University of Utah, Salt Lake City.

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COVID-19 has posed serious questions for patients with psoriatic disease and the clinicians who treat them. Both have serious concerns over whether psoriasis or the medications used to treat it pose additional risk for contracting COVID-19 or experiencing worse outcomes with illness.

At the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, experts gathered to discuss these concerns and what is known about the special risk factors for psoriatic disease patients.

Dr. Kevin Winthrop

Studies from a few registries have been done already among patients with autoimmune disease, and the results so far suggest that patients may be able to breathe a little easier. “I don’t see any data that suggests that use of immunosuppressives or having autoimmune disease increases your risk of acquiring it. I think most of the risk is driven by risk of exposure,” said Kevin Winthrop, MD, MPH, a professor of public health, infectious diseases, ophthalmology at Oregon Health & Science University, Portland, during a presentation.

That assertion was reinforced by data presented by Rebecca Haberman, MD, a rheumatologist at New York University Langone Health. Her group created the Web-Based Assessment of Autoimmune, Immune-Mediated, and Rheumatic Patients during the COVID-19 Pandemic (WARCOV) cohort study to address the question of whether patients with immune-mediated inflammatory disease (IMID), including inflammatory arthritis, psoriasis, or inflammatory bowel disease, should discontinue or modify their immunotherapy regimens in the face of potential exposure to COVID-19.



To date, the study has data on 1,122 patients; 604 with inflammatory arthritis, 128 of whom have tested positive for COVID-19. The team established a cohort using the first 86 IMID patients confirmed to have contracted COVID-19. The hospitalization rate was 16% overall, and use of corticosteroids was associated with increased hospitalization risk. A follow-up analysis looking at the first 103 inflammatory arthritis patients who contracted COVID-19 showed a hospitalization rate of 26% and a mortality of 4%. That hospitalization rate is similar to the general hospitalization rate estimated by the New York Department of Health, Dr. Haberman said in her presentation.

Risk factors associated with hospitalization included being older and having asthma or COPD, which is similar to the general population. Use of oral glucocorticoids was linked to a big increase in risk for hospitalization, even with doses less than 10 mg prednisone daily (odds ratio, 14.31; 95% confidence interval, 3.55-57.70). There were no links between use of any cytokine therapy and risk, but use of TNF inhibitors was associated with a reduced risk (OR, 0.35; 95% CI, 0.13-0.97), while use of JAK inhibitors was associated with greater risk (OR, 6.30; 95% CI, 1.68-23.69). The latter result is tentative because of a small sample size, and it was driven largely by the experiences of patients with psoriatic arthritis.

Dr. Leonard Calabrese

Another study, run by the COVID-19 Global Rheumatology Alliance, looked at 600 patients with rheumatic disease from 40 countries, and “found no smoking gun,” said Leonard Calabrese, DO, who leads the Cleveland Clinic’s section of clinical immunology, during his presentation. “People can develop this when they’re on hydroxychloroquine. They seem to do not remarkably bad or remarkably good. There is no adverse signal for biologics, but being on prednisone [at a dose of] more than 10 mg is not great,” said Dr. Calabrese, who also noted that other publications have supported these conclusions.

So given these findings, how should clinicians address patient concerns? In the absence of probable exposure, “we say it’s better to have a well-controlled IMID on therapy than a poorly-controlled IMID on submaximal therapy. We say stick to therapy and try to wean the prednisone down as low as possible,” Dr. Calabrese said.

More controversially, what should patients do if they have had a significant exposure, such as a close proximity, prolonged exposure encounter with an individual with documented COVID-19, or at high-risk of disease? Dr. Calabrese noted that the American College of Rheumatology (ACR) guidelines recommend that low-level immunomodulation can be continued, “with an asterisk if it’s hydroxychloroquine, and it is in most of our minds now that we know that it is not effective, and the toxicity in the COVID setting is still being worked out,” he said.

With respect to other immunosuppressants, the ACR recommends stopping them temporarily, although IL-6 inhibitors may be continued in select circumstances. Resumption of the therapeutics can resume after a negative COVID test or completion of a 2-week observation period.

When patients contract COVID-19, antimalarial medications can be continued because they have been studied. “But medium-level immunomodulators, in particular methotrexate, I have grave concerns about because it can inhibit the adaptive immune response and antibody formation,” he said. COVID-19 is a serious infection, and all serious biologics have a package insert saying to stop them in a serious infection. Again, IL-6 inhibitors may be considered an exception in the right circumstances. When to resume these medications remains unknown. “I think that’s a work in progress. Test-based versus clinic-based strategies are a matter of controversy,” Dr. Calabrese said.

Dr. Kristina Duffin

Ultimately, the question of what to do with immunosuppressive therapies in this population will continue to be a challenge. “The only good answer is to follow the rules of social distancing and to wear a mask,” said Kristina Callis Duffin, MD, a cochair of the department of dermatology and associate professor of dermatology at the University of Utah, Salt Lake City.

COVID-19 has posed serious questions for patients with psoriatic disease and the clinicians who treat them. Both have serious concerns over whether psoriasis or the medications used to treat it pose additional risk for contracting COVID-19 or experiencing worse outcomes with illness.

At the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, experts gathered to discuss these concerns and what is known about the special risk factors for psoriatic disease patients.

Dr. Kevin Winthrop

Studies from a few registries have been done already among patients with autoimmune disease, and the results so far suggest that patients may be able to breathe a little easier. “I don’t see any data that suggests that use of immunosuppressives or having autoimmune disease increases your risk of acquiring it. I think most of the risk is driven by risk of exposure,” said Kevin Winthrop, MD, MPH, a professor of public health, infectious diseases, ophthalmology at Oregon Health & Science University, Portland, during a presentation.

That assertion was reinforced by data presented by Rebecca Haberman, MD, a rheumatologist at New York University Langone Health. Her group created the Web-Based Assessment of Autoimmune, Immune-Mediated, and Rheumatic Patients during the COVID-19 Pandemic (WARCOV) cohort study to address the question of whether patients with immune-mediated inflammatory disease (IMID), including inflammatory arthritis, psoriasis, or inflammatory bowel disease, should discontinue or modify their immunotherapy regimens in the face of potential exposure to COVID-19.



To date, the study has data on 1,122 patients; 604 with inflammatory arthritis, 128 of whom have tested positive for COVID-19. The team established a cohort using the first 86 IMID patients confirmed to have contracted COVID-19. The hospitalization rate was 16% overall, and use of corticosteroids was associated with increased hospitalization risk. A follow-up analysis looking at the first 103 inflammatory arthritis patients who contracted COVID-19 showed a hospitalization rate of 26% and a mortality of 4%. That hospitalization rate is similar to the general hospitalization rate estimated by the New York Department of Health, Dr. Haberman said in her presentation.

Risk factors associated with hospitalization included being older and having asthma or COPD, which is similar to the general population. Use of oral glucocorticoids was linked to a big increase in risk for hospitalization, even with doses less than 10 mg prednisone daily (odds ratio, 14.31; 95% confidence interval, 3.55-57.70). There were no links between use of any cytokine therapy and risk, but use of TNF inhibitors was associated with a reduced risk (OR, 0.35; 95% CI, 0.13-0.97), while use of JAK inhibitors was associated with greater risk (OR, 6.30; 95% CI, 1.68-23.69). The latter result is tentative because of a small sample size, and it was driven largely by the experiences of patients with psoriatic arthritis.

Dr. Leonard Calabrese

Another study, run by the COVID-19 Global Rheumatology Alliance, looked at 600 patients with rheumatic disease from 40 countries, and “found no smoking gun,” said Leonard Calabrese, DO, who leads the Cleveland Clinic’s section of clinical immunology, during his presentation. “People can develop this when they’re on hydroxychloroquine. They seem to do not remarkably bad or remarkably good. There is no adverse signal for biologics, but being on prednisone [at a dose of] more than 10 mg is not great,” said Dr. Calabrese, who also noted that other publications have supported these conclusions.

So given these findings, how should clinicians address patient concerns? In the absence of probable exposure, “we say it’s better to have a well-controlled IMID on therapy than a poorly-controlled IMID on submaximal therapy. We say stick to therapy and try to wean the prednisone down as low as possible,” Dr. Calabrese said.

More controversially, what should patients do if they have had a significant exposure, such as a close proximity, prolonged exposure encounter with an individual with documented COVID-19, or at high-risk of disease? Dr. Calabrese noted that the American College of Rheumatology (ACR) guidelines recommend that low-level immunomodulation can be continued, “with an asterisk if it’s hydroxychloroquine, and it is in most of our minds now that we know that it is not effective, and the toxicity in the COVID setting is still being worked out,” he said.

With respect to other immunosuppressants, the ACR recommends stopping them temporarily, although IL-6 inhibitors may be continued in select circumstances. Resumption of the therapeutics can resume after a negative COVID test or completion of a 2-week observation period.

When patients contract COVID-19, antimalarial medications can be continued because they have been studied. “But medium-level immunomodulators, in particular methotrexate, I have grave concerns about because it can inhibit the adaptive immune response and antibody formation,” he said. COVID-19 is a serious infection, and all serious biologics have a package insert saying to stop them in a serious infection. Again, IL-6 inhibitors may be considered an exception in the right circumstances. When to resume these medications remains unknown. “I think that’s a work in progress. Test-based versus clinic-based strategies are a matter of controversy,” Dr. Calabrese said.

Dr. Kristina Duffin

Ultimately, the question of what to do with immunosuppressive therapies in this population will continue to be a challenge. “The only good answer is to follow the rules of social distancing and to wear a mask,” said Kristina Callis Duffin, MD, a cochair of the department of dermatology and associate professor of dermatology at the University of Utah, Salt Lake City.

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FROM THE GRAPPA 2020 VIRTUAL ANNUAL MEETING

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Racial differences in rates of atopic dermatitis observed early in life

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Racial differences in the rates of atopic dermatitis appear to arise early in life, results from a single-center retrospective study found.

©Radist/Thinkstock

“Atopic dermatitis is a very common pediatric skin condition with significant morbidity for patients and their families,” lead study author Reesa L. Monir, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology. “Existing studies show increased disease prevalence in Black and Asian children relative to White children, with conflicting data for Hispanic children. The methodology behind many of these existing studies, however, is somewhat questionable. Many were survey-based studies asking parents to remember a diagnosis of eczema or even asking parents to just report an itchy rash and using that as a diagnosis.”

For the current study, Dr. Monir and colleagues reviewed the records of 4,016 infants born between June 1, 2011, and April 30, 2017, who were followed in the University of Florida’s health care system. The researchers defined this as having two or more well-child visits after birth and at least one visit at 300 days of life or later, and the used documentation of specific ICD-9 or ICD-10 codes to capture an objective diagnosis of atopic dermatitis (AD). Of the 4,016 patients, 39.2% were Black, 38.5% were White, 7.1% were Hispanic, 5.3% were Asian, 6.5% were from other racial backgrounds, and 3.4% were multiracial.



Dr. Monir, who is a resident in the department of dermatology at the University of Florida, Gainesville, reported that Black infants had the highest prevalence of AD at 37%, followed by Asian infants (25.8%), Hispanic infants (24.1%), multiracial infants (23%), infants from other racial backgrounds (19.1%), and non-Hispanic White infants (17.9%). Compared with White infants, the odds ratio estimates for AD was highest for Black infants (OR, 2.62), followed by Asian infants (OR, 1.55), multiracial infants (OR, 1.42), Hispanic infants (OR, 1.41), and infants from other racial backgrounds (OR, .97).

On unadjusted analysis, the following factors were significantly associated with race: delivery mode (P = .006), insurance type (P less than .001), NICU stay (P less than .001), and gestational age (P less than .0001). However, on multivariate logistic regression, only two factors were significantly associated with the diagnosis of AD: race (P less than .0001) and NICU stay (P = .0385).

“When we looked at the early childhood period specifically, we found striking racial differences in the rates of AD arising early in life,” Dr. Monir concluded. “The diagnosis was independently associated with race and NICU stay. We suggest that further investigation into these disparities and ways we can mitigate them should focus on this early childhood period.”

The researchers reported having no relevant financial disclosures.

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Racial differences in the rates of atopic dermatitis appear to arise early in life, results from a single-center retrospective study found.

©Radist/Thinkstock

“Atopic dermatitis is a very common pediatric skin condition with significant morbidity for patients and their families,” lead study author Reesa L. Monir, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology. “Existing studies show increased disease prevalence in Black and Asian children relative to White children, with conflicting data for Hispanic children. The methodology behind many of these existing studies, however, is somewhat questionable. Many were survey-based studies asking parents to remember a diagnosis of eczema or even asking parents to just report an itchy rash and using that as a diagnosis.”

For the current study, Dr. Monir and colleagues reviewed the records of 4,016 infants born between June 1, 2011, and April 30, 2017, who were followed in the University of Florida’s health care system. The researchers defined this as having two or more well-child visits after birth and at least one visit at 300 days of life or later, and the used documentation of specific ICD-9 or ICD-10 codes to capture an objective diagnosis of atopic dermatitis (AD). Of the 4,016 patients, 39.2% were Black, 38.5% were White, 7.1% were Hispanic, 5.3% were Asian, 6.5% were from other racial backgrounds, and 3.4% were multiracial.



Dr. Monir, who is a resident in the department of dermatology at the University of Florida, Gainesville, reported that Black infants had the highest prevalence of AD at 37%, followed by Asian infants (25.8%), Hispanic infants (24.1%), multiracial infants (23%), infants from other racial backgrounds (19.1%), and non-Hispanic White infants (17.9%). Compared with White infants, the odds ratio estimates for AD was highest for Black infants (OR, 2.62), followed by Asian infants (OR, 1.55), multiracial infants (OR, 1.42), Hispanic infants (OR, 1.41), and infants from other racial backgrounds (OR, .97).

On unadjusted analysis, the following factors were significantly associated with race: delivery mode (P = .006), insurance type (P less than .001), NICU stay (P less than .001), and gestational age (P less than .0001). However, on multivariate logistic regression, only two factors were significantly associated with the diagnosis of AD: race (P less than .0001) and NICU stay (P = .0385).

“When we looked at the early childhood period specifically, we found striking racial differences in the rates of AD arising early in life,” Dr. Monir concluded. “The diagnosis was independently associated with race and NICU stay. We suggest that further investigation into these disparities and ways we can mitigate them should focus on this early childhood period.”

The researchers reported having no relevant financial disclosures.

Racial differences in the rates of atopic dermatitis appear to arise early in life, results from a single-center retrospective study found.

©Radist/Thinkstock

“Atopic dermatitis is a very common pediatric skin condition with significant morbidity for patients and their families,” lead study author Reesa L. Monir, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology. “Existing studies show increased disease prevalence in Black and Asian children relative to White children, with conflicting data for Hispanic children. The methodology behind many of these existing studies, however, is somewhat questionable. Many were survey-based studies asking parents to remember a diagnosis of eczema or even asking parents to just report an itchy rash and using that as a diagnosis.”

For the current study, Dr. Monir and colleagues reviewed the records of 4,016 infants born between June 1, 2011, and April 30, 2017, who were followed in the University of Florida’s health care system. The researchers defined this as having two or more well-child visits after birth and at least one visit at 300 days of life or later, and the used documentation of specific ICD-9 or ICD-10 codes to capture an objective diagnosis of atopic dermatitis (AD). Of the 4,016 patients, 39.2% were Black, 38.5% were White, 7.1% were Hispanic, 5.3% were Asian, 6.5% were from other racial backgrounds, and 3.4% were multiracial.



Dr. Monir, who is a resident in the department of dermatology at the University of Florida, Gainesville, reported that Black infants had the highest prevalence of AD at 37%, followed by Asian infants (25.8%), Hispanic infants (24.1%), multiracial infants (23%), infants from other racial backgrounds (19.1%), and non-Hispanic White infants (17.9%). Compared with White infants, the odds ratio estimates for AD was highest for Black infants (OR, 2.62), followed by Asian infants (OR, 1.55), multiracial infants (OR, 1.42), Hispanic infants (OR, 1.41), and infants from other racial backgrounds (OR, .97).

On unadjusted analysis, the following factors were significantly associated with race: delivery mode (P = .006), insurance type (P less than .001), NICU stay (P less than .001), and gestational age (P less than .0001). However, on multivariate logistic regression, only two factors were significantly associated with the diagnosis of AD: race (P less than .0001) and NICU stay (P = .0385).

“When we looked at the early childhood period specifically, we found striking racial differences in the rates of AD arising early in life,” Dr. Monir concluded. “The diagnosis was independently associated with race and NICU stay. We suggest that further investigation into these disparities and ways we can mitigate them should focus on this early childhood period.”

The researchers reported having no relevant financial disclosures.

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Why doctors keep monitoring kids who recover from mysterious COVID-linked illness

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Tue, 02/14/2023 - 13:01

Israel Shippy doesn’t remember much about having COVID-19 – or the unusual autoimmune disease it triggered – other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old boy and would much rather talk about cartoons or the ideas for inventions that constantly pop into his head.

“Hold your horses, I think I know what I’m gonna make,” he said, holding up a finger in the middle of a conversation. “I’m gonna make something that lights up and attaches to things with glue, so if you don’t have a flashlight, you can just use it!”

In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children (MIS-C). And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.

A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, finding that about 1,000 children worldwide have been diagnosed with MIS-C.
 

Tracking the long-term health effects of MIS-C

Israel is friendly and energetic, but he’s also really good at sitting still. During a recent checkup at the Children’s Hospital at Montefiore, New York, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Marc Foca, MD, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.

There were still some tests pending, but overall, Dr. Foca said, “Israel looks like a totally healthy 5-year-old.”

“Stay safe!” Israel called out, as Dr. Foca left. It’s his new sign-off, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself. And she’s also hoping that, after a harrowing couple of weeks in early May, Israel himself will “stay safe.”

That’s why they’ve been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.

MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough – and mysterious enough – that doctors here want to make sure the children who recover don’t experience any related health complications in the future.

“We’ve seen these kids get really sick, and get better and recover and go home, yet we don’t know what the long-term outcomes are,” said Nadine Choueiter, MD, a pediatric cardiologist at Montefiore. “So that’s why we will be seeing them.”

When Israel first got sick at the end of April, his illness didn’t exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104° F – but no problems breathing. He wasn’t eating. He was barely drinking. He wasn’t using the bathroom. He had abdominal pains. His eyes were red.

They went to the ED a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Ms. Moholland, 29, said she felt powerless.

“There was nothing I could do but make him comfortable,” she said. “I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith.”

As Israel grew sicker, and they still had no answers, Ms. Moholland grew frustrated. “I wish his pediatrician and [the ED and urgent care staff] had done what they were supposed to do and given him a test” when Israel first got sick, Ms. Moholland said. “What harm would it have done? He suffered for about 10 or 11 days that could have been avoided.”

In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community because of a combination of underlying health conditions and lack of access to good health care. She said she felt she, too, had fallen victim to those disparities.

“It affects me, personally, because I am African American, but you just never know,” she said. “It’s hard. We’re living in uncertain times – very uncertain times.”

Finally, the Children’s Hospital at Montefiore admitted Israel – and the test she’d been trying to get for days confirmed he had the virus.

“I was literally in tears, like begging them not to discharge me because I knew he was not fine,” she recalled.

Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms – which were distinct from most people with COVID-19.

Doctors gave Israel fluids and intravenous immunoglobulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.

Immunoglobulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Dr. Choueiter.

“The immune system starts attacking the body itself, including the arteries of the heart,” she said.

In some MIS-C cases – though not Israel’s – the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms – which can fatally rupture blood vessels – after the initial condition subsides.

Dr. Choueiter and colleagues want to make sure MIS-C patients don’t face similar risks. So far, they’re cautiously optimistic.

“We have not seen any new decrease in heart function or any new coronary artery dilations,” she said. “When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it’s as if this illness is a nightmare that’s long gone.”
 

 

 

For a Pennsylvania teen, the MIS-C diagnosis came much later

Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.

Andrew had been a healthy 14-year-old boy before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.

“It was terrible,” Andrew said. “It was unbearable. I couldn’t really move a lot.”

His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, “I knew I couldn’t keep him home anymore,” Mrs. Lis said.

Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.

Over about 5 days in the pediatric ICU, Andrew’s condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat, and toxic shock syndrome. Andrew’s body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew’s father, Ed Lis, said doctors told the family to brace for the worst: “We’ve got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they’re telling us that we could lose him.”

Though Andrew’s symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition – administering intravenous immunoglobulin, the same treatment Israel Shippy received.

“Within the 24 hours of the infusion, he was a different person,” Mrs. Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. “That’s when we knew that we had turned that corner.”

It wasn’t until after Andrew’s discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family – both parents, Andrew’s twin brother and two older siblings – all tested negative. Andrew’s mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.

And she’s puzzled why the rest of her close-knit family wasn’t infected as well. “We are a Latino family,” Mrs. Lis said. “We are very used to being together, clustering in the same room.” Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.

Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, push-ups, and sit-ups. A few weeks later, an ECG showed Andrew’s heart was “perfect,” Mr. Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every 3 months.
 

 

 

An eye on the long-term effects

The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Dr. Choueiter hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.

“Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first 6 weeks of the illness do well long-term,” said Dr. Choueiter, who runs the Kawasaki disease program at Montefiore.

The Montefiore team is asking patients affected by MIS-C to return for a checkup 1 week after discharge, then after 1 month, 3 months, 6 months, and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.

Montefiore and other children’s hospitals around the country are sharing information. Dr. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable with registries that exist for other diseases.

Ms. Moholland is glad the hospital is being vigilant.

“The uncertainty of not knowing whether it could come back in his future is a little unsettling,” she said. “But I am hopeful.”

This story is part of a partnership that includes WNYC, NPR, and Kaiser Health News. A version of this article originally appeared on Kaiser Health News.

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Israel Shippy doesn’t remember much about having COVID-19 – or the unusual autoimmune disease it triggered – other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old boy and would much rather talk about cartoons or the ideas for inventions that constantly pop into his head.

“Hold your horses, I think I know what I’m gonna make,” he said, holding up a finger in the middle of a conversation. “I’m gonna make something that lights up and attaches to things with glue, so if you don’t have a flashlight, you can just use it!”

In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children (MIS-C). And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.

A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, finding that about 1,000 children worldwide have been diagnosed with MIS-C.
 

Tracking the long-term health effects of MIS-C

Israel is friendly and energetic, but he’s also really good at sitting still. During a recent checkup at the Children’s Hospital at Montefiore, New York, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Marc Foca, MD, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.

There were still some tests pending, but overall, Dr. Foca said, “Israel looks like a totally healthy 5-year-old.”

“Stay safe!” Israel called out, as Dr. Foca left. It’s his new sign-off, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself. And she’s also hoping that, after a harrowing couple of weeks in early May, Israel himself will “stay safe.”

That’s why they’ve been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.

MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough – and mysterious enough – that doctors here want to make sure the children who recover don’t experience any related health complications in the future.

“We’ve seen these kids get really sick, and get better and recover and go home, yet we don’t know what the long-term outcomes are,” said Nadine Choueiter, MD, a pediatric cardiologist at Montefiore. “So that’s why we will be seeing them.”

When Israel first got sick at the end of April, his illness didn’t exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104° F – but no problems breathing. He wasn’t eating. He was barely drinking. He wasn’t using the bathroom. He had abdominal pains. His eyes were red.

They went to the ED a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Ms. Moholland, 29, said she felt powerless.

“There was nothing I could do but make him comfortable,” she said. “I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith.”

As Israel grew sicker, and they still had no answers, Ms. Moholland grew frustrated. “I wish his pediatrician and [the ED and urgent care staff] had done what they were supposed to do and given him a test” when Israel first got sick, Ms. Moholland said. “What harm would it have done? He suffered for about 10 or 11 days that could have been avoided.”

In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community because of a combination of underlying health conditions and lack of access to good health care. She said she felt she, too, had fallen victim to those disparities.

“It affects me, personally, because I am African American, but you just never know,” she said. “It’s hard. We’re living in uncertain times – very uncertain times.”

Finally, the Children’s Hospital at Montefiore admitted Israel – and the test she’d been trying to get for days confirmed he had the virus.

“I was literally in tears, like begging them not to discharge me because I knew he was not fine,” she recalled.

Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms – which were distinct from most people with COVID-19.

Doctors gave Israel fluids and intravenous immunoglobulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.

Immunoglobulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Dr. Choueiter.

“The immune system starts attacking the body itself, including the arteries of the heart,” she said.

In some MIS-C cases – though not Israel’s – the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms – which can fatally rupture blood vessels – after the initial condition subsides.

Dr. Choueiter and colleagues want to make sure MIS-C patients don’t face similar risks. So far, they’re cautiously optimistic.

“We have not seen any new decrease in heart function or any new coronary artery dilations,” she said. “When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it’s as if this illness is a nightmare that’s long gone.”
 

 

 

For a Pennsylvania teen, the MIS-C diagnosis came much later

Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.

Andrew had been a healthy 14-year-old boy before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.

“It was terrible,” Andrew said. “It was unbearable. I couldn’t really move a lot.”

His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, “I knew I couldn’t keep him home anymore,” Mrs. Lis said.

Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.

Over about 5 days in the pediatric ICU, Andrew’s condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat, and toxic shock syndrome. Andrew’s body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew’s father, Ed Lis, said doctors told the family to brace for the worst: “We’ve got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they’re telling us that we could lose him.”

Though Andrew’s symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition – administering intravenous immunoglobulin, the same treatment Israel Shippy received.

“Within the 24 hours of the infusion, he was a different person,” Mrs. Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. “That’s when we knew that we had turned that corner.”

It wasn’t until after Andrew’s discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family – both parents, Andrew’s twin brother and two older siblings – all tested negative. Andrew’s mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.

And she’s puzzled why the rest of her close-knit family wasn’t infected as well. “We are a Latino family,” Mrs. Lis said. “We are very used to being together, clustering in the same room.” Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.

Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, push-ups, and sit-ups. A few weeks later, an ECG showed Andrew’s heart was “perfect,” Mr. Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every 3 months.
 

 

 

An eye on the long-term effects

The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Dr. Choueiter hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.

“Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first 6 weeks of the illness do well long-term,” said Dr. Choueiter, who runs the Kawasaki disease program at Montefiore.

The Montefiore team is asking patients affected by MIS-C to return for a checkup 1 week after discharge, then after 1 month, 3 months, 6 months, and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.

Montefiore and other children’s hospitals around the country are sharing information. Dr. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable with registries that exist for other diseases.

Ms. Moholland is glad the hospital is being vigilant.

“The uncertainty of not knowing whether it could come back in his future is a little unsettling,” she said. “But I am hopeful.”

This story is part of a partnership that includes WNYC, NPR, and Kaiser Health News. A version of this article originally appeared on Kaiser Health News.

Israel Shippy doesn’t remember much about having COVID-19 – or the unusual autoimmune disease it triggered – other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old boy and would much rather talk about cartoons or the ideas for inventions that constantly pop into his head.

“Hold your horses, I think I know what I’m gonna make,” he said, holding up a finger in the middle of a conversation. “I’m gonna make something that lights up and attaches to things with glue, so if you don’t have a flashlight, you can just use it!”

In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children (MIS-C). And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.

A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, finding that about 1,000 children worldwide have been diagnosed with MIS-C.
 

Tracking the long-term health effects of MIS-C

Israel is friendly and energetic, but he’s also really good at sitting still. During a recent checkup at the Children’s Hospital at Montefiore, New York, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Marc Foca, MD, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.

There were still some tests pending, but overall, Dr. Foca said, “Israel looks like a totally healthy 5-year-old.”

“Stay safe!” Israel called out, as Dr. Foca left. It’s his new sign-off, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself. And she’s also hoping that, after a harrowing couple of weeks in early May, Israel himself will “stay safe.”

That’s why they’ve been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.

MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough – and mysterious enough – that doctors here want to make sure the children who recover don’t experience any related health complications in the future.

“We’ve seen these kids get really sick, and get better and recover and go home, yet we don’t know what the long-term outcomes are,” said Nadine Choueiter, MD, a pediatric cardiologist at Montefiore. “So that’s why we will be seeing them.”

When Israel first got sick at the end of April, his illness didn’t exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104° F – but no problems breathing. He wasn’t eating. He was barely drinking. He wasn’t using the bathroom. He had abdominal pains. His eyes were red.

They went to the ED a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Ms. Moholland, 29, said she felt powerless.

“There was nothing I could do but make him comfortable,” she said. “I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith.”

As Israel grew sicker, and they still had no answers, Ms. Moholland grew frustrated. “I wish his pediatrician and [the ED and urgent care staff] had done what they were supposed to do and given him a test” when Israel first got sick, Ms. Moholland said. “What harm would it have done? He suffered for about 10 or 11 days that could have been avoided.”

In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community because of a combination of underlying health conditions and lack of access to good health care. She said she felt she, too, had fallen victim to those disparities.

“It affects me, personally, because I am African American, but you just never know,” she said. “It’s hard. We’re living in uncertain times – very uncertain times.”

Finally, the Children’s Hospital at Montefiore admitted Israel – and the test she’d been trying to get for days confirmed he had the virus.

“I was literally in tears, like begging them not to discharge me because I knew he was not fine,” she recalled.

Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms – which were distinct from most people with COVID-19.

Doctors gave Israel fluids and intravenous immunoglobulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.

Immunoglobulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Dr. Choueiter.

“The immune system starts attacking the body itself, including the arteries of the heart,” she said.

In some MIS-C cases – though not Israel’s – the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms – which can fatally rupture blood vessels – after the initial condition subsides.

Dr. Choueiter and colleagues want to make sure MIS-C patients don’t face similar risks. So far, they’re cautiously optimistic.

“We have not seen any new decrease in heart function or any new coronary artery dilations,” she said. “When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it’s as if this illness is a nightmare that’s long gone.”
 

 

 

For a Pennsylvania teen, the MIS-C diagnosis came much later

Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del.

Andrew had been a healthy 14-year-old boy before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.

“It was terrible,” Andrew said. “It was unbearable. I couldn’t really move a lot.”

His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, “I knew I couldn’t keep him home anymore,” Mrs. Lis said.

Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.

Over about 5 days in the pediatric ICU, Andrew’s condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat, and toxic shock syndrome. Andrew’s body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew’s father, Ed Lis, said doctors told the family to brace for the worst: “We’ve got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they’re telling us that we could lose him.”

Though Andrew’s symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition – administering intravenous immunoglobulin, the same treatment Israel Shippy received.

“Within the 24 hours of the infusion, he was a different person,” Mrs. Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. “That’s when we knew that we had turned that corner.”

It wasn’t until after Andrew’s discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family – both parents, Andrew’s twin brother and two older siblings – all tested negative. Andrew’s mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.

And she’s puzzled why the rest of her close-knit family wasn’t infected as well. “We are a Latino family,” Mrs. Lis said. “We are very used to being together, clustering in the same room.” Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.

Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, push-ups, and sit-ups. A few weeks later, an ECG showed Andrew’s heart was “perfect,” Mr. Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every 3 months.
 

 

 

An eye on the long-term effects

The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Dr. Choueiter hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.

“Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first 6 weeks of the illness do well long-term,” said Dr. Choueiter, who runs the Kawasaki disease program at Montefiore.

The Montefiore team is asking patients affected by MIS-C to return for a checkup 1 week after discharge, then after 1 month, 3 months, 6 months, and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.

Montefiore and other children’s hospitals around the country are sharing information. Dr. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable with registries that exist for other diseases.

Ms. Moholland is glad the hospital is being vigilant.

“The uncertainty of not knowing whether it could come back in his future is a little unsettling,” she said. “But I am hopeful.”

This story is part of a partnership that includes WNYC, NPR, and Kaiser Health News. A version of this article originally appeared on Kaiser Health News.

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Stillbirth incidence increases during COVID-19 pandemic

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The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.

“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.

To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.

Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).

None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.

“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.

She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.

“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”

“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”

The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”

One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.

SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.

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The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.

“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.

To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.

Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).

None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.

“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.

She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.

“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”

“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”

The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”

One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.

SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.

The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.

“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.

To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.

Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).

None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.

“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.

She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.

“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”

“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”

The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”

One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.

SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.

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Rilzabrutinib shows positive results in phase 2b for pemphigus

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Mon, 07/20/2020 - 09:49

Rilzabrutinib, a novel oral reversible Bruton’s tyrosine kinase inhibitor, delivered rapid control of pemphigus disease activity accompanied by markedly reduced need for systemic corticosteroids in the phase 2b BELIEVE-PV trial, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Dr. Dedee Murrell

Moreover, in sharp contrast to the standard first-line treatments for pemphigus – rituximab (Rituxan) and high-dose corticosteroids – the treatment-emergent adverse events that arose with 6 months of rilzabrutinib in BELIEVE-PV were uniformly mild to moderate and transient, added Dr. Murrell, professor of dermatology at the University of New South Wales and head of the department of dermatology at St. George University Hospital, Sydney.

The phase 2b BELIEVE-PV trial was a small, 24-week, open-label study that included six patients with newly diagnosed pemphigus and nine others with relapsing pemphigus. The primary endpoint was control of disease activity, defined as no new lesions appearing and established lesions beginning to heal. This was achieved in 9 of 15 patients (60%) at 4 weeks and in 13 patients by week 12. Meanwhile, the mean daily dose of prednisone fell from 21 mg at baseline to 6 mg at 24 weeks.



The mean score on the Pemphigus Disease Area Index (PDAI) dropped by 79% from a baseline of 15.5. Ten of 15 subjects improved to a PDAI of 0 or 1 – clear or almost clear skin – by week 24. The complete remission rate, defined as an absence of both new and established lesions while on no or a very low dose of prednisone, was 40% at week 24.

Treatment-emergent adverse events consisted of nausea in four patients, dizziness in two, and abdominal distension in two, all of which were grade 1 or 2.

Based upon these favorable results, the pivotal phase 3, double-blind, international PEGASUS trial is underway, led by Dr. Murrell. The trial will enroll 120 pemphigus patients, randomized to rilzabrutinib at 400 mg twice daily or placebo on top of background steroid tapering.

Rilzabrutinib is also in earlier-stage clinical trials for the treatment of immune thrombocytopenia.

Dr. Murrell reported serving as a consultant to Principia Biopharma, sponsor of the BELIEVE-PV and PEGASUS trials, and has received institutional research grants from numerous pharmaceutical companies.

SOURCE: Murrell DF. AAD 2020 LBCT.

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Rilzabrutinib, a novel oral reversible Bruton’s tyrosine kinase inhibitor, delivered rapid control of pemphigus disease activity accompanied by markedly reduced need for systemic corticosteroids in the phase 2b BELIEVE-PV trial, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Dr. Dedee Murrell

Moreover, in sharp contrast to the standard first-line treatments for pemphigus – rituximab (Rituxan) and high-dose corticosteroids – the treatment-emergent adverse events that arose with 6 months of rilzabrutinib in BELIEVE-PV were uniformly mild to moderate and transient, added Dr. Murrell, professor of dermatology at the University of New South Wales and head of the department of dermatology at St. George University Hospital, Sydney.

The phase 2b BELIEVE-PV trial was a small, 24-week, open-label study that included six patients with newly diagnosed pemphigus and nine others with relapsing pemphigus. The primary endpoint was control of disease activity, defined as no new lesions appearing and established lesions beginning to heal. This was achieved in 9 of 15 patients (60%) at 4 weeks and in 13 patients by week 12. Meanwhile, the mean daily dose of prednisone fell from 21 mg at baseline to 6 mg at 24 weeks.



The mean score on the Pemphigus Disease Area Index (PDAI) dropped by 79% from a baseline of 15.5. Ten of 15 subjects improved to a PDAI of 0 or 1 – clear or almost clear skin – by week 24. The complete remission rate, defined as an absence of both new and established lesions while on no or a very low dose of prednisone, was 40% at week 24.

Treatment-emergent adverse events consisted of nausea in four patients, dizziness in two, and abdominal distension in two, all of which were grade 1 or 2.

Based upon these favorable results, the pivotal phase 3, double-blind, international PEGASUS trial is underway, led by Dr. Murrell. The trial will enroll 120 pemphigus patients, randomized to rilzabrutinib at 400 mg twice daily or placebo on top of background steroid tapering.

Rilzabrutinib is also in earlier-stage clinical trials for the treatment of immune thrombocytopenia.

Dr. Murrell reported serving as a consultant to Principia Biopharma, sponsor of the BELIEVE-PV and PEGASUS trials, and has received institutional research grants from numerous pharmaceutical companies.

SOURCE: Murrell DF. AAD 2020 LBCT.

Rilzabrutinib, a novel oral reversible Bruton’s tyrosine kinase inhibitor, delivered rapid control of pemphigus disease activity accompanied by markedly reduced need for systemic corticosteroids in the phase 2b BELIEVE-PV trial, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.

Dr. Dedee Murrell

Moreover, in sharp contrast to the standard first-line treatments for pemphigus – rituximab (Rituxan) and high-dose corticosteroids – the treatment-emergent adverse events that arose with 6 months of rilzabrutinib in BELIEVE-PV were uniformly mild to moderate and transient, added Dr. Murrell, professor of dermatology at the University of New South Wales and head of the department of dermatology at St. George University Hospital, Sydney.

The phase 2b BELIEVE-PV trial was a small, 24-week, open-label study that included six patients with newly diagnosed pemphigus and nine others with relapsing pemphigus. The primary endpoint was control of disease activity, defined as no new lesions appearing and established lesions beginning to heal. This was achieved in 9 of 15 patients (60%) at 4 weeks and in 13 patients by week 12. Meanwhile, the mean daily dose of prednisone fell from 21 mg at baseline to 6 mg at 24 weeks.



The mean score on the Pemphigus Disease Area Index (PDAI) dropped by 79% from a baseline of 15.5. Ten of 15 subjects improved to a PDAI of 0 or 1 – clear or almost clear skin – by week 24. The complete remission rate, defined as an absence of both new and established lesions while on no or a very low dose of prednisone, was 40% at week 24.

Treatment-emergent adverse events consisted of nausea in four patients, dizziness in two, and abdominal distension in two, all of which were grade 1 or 2.

Based upon these favorable results, the pivotal phase 3, double-blind, international PEGASUS trial is underway, led by Dr. Murrell. The trial will enroll 120 pemphigus patients, randomized to rilzabrutinib at 400 mg twice daily or placebo on top of background steroid tapering.

Rilzabrutinib is also in earlier-stage clinical trials for the treatment of immune thrombocytopenia.

Dr. Murrell reported serving as a consultant to Principia Biopharma, sponsor of the BELIEVE-PV and PEGASUS trials, and has received institutional research grants from numerous pharmaceutical companies.

SOURCE: Murrell DF. AAD 2020 LBCT.

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