Buprenorphine Slightly Less Risky than Methadone for Fetal Malformation

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Buprenorphine use, compared with methadone use, in pregnancy has been linked with a slightly lower risk of major congenital malformations in a new study of medications for opioid use disorder (OUD).

Elizabeth A. Suarez, PhD, MPH, with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues published the findings in JAMA Internal Medicine.

The lower risk for buprenorphine was small (risk ratio, 0.82; 95% confidence interval [CI], 0.69-0.97), and methadone use should not be ruled out on that basis, the authors wrote. For some women, particularly those on stable treatment before pregnancy or women who do not respond well to buprenorphine, methadone may be the better choice, they explained.
 

Either Medication Better Than Not Treating

The authors noted that either medication “is strongly recommended over untreated OUD during pregnancy.”

JAMA Internal Medicine Deputy Editor Deborah Grady, MD, MPH, with the Department of Medicine, University of California, San Francisco, emphasized that recommendation in an editor’s note, highlighting that treatment for OUD is critical to prevent infections, overdose, and death in pregnant women as well as neonatal opioid withdrawal syndrome and fetal death.

She stressed that internists and other primary care physicians have a key role in ensuring pregnant women with OUD receive appropriate treatment.

Given the importance of the issue, she wrote, “we have taken the unusual step of publishing two accompanying invited commentaries.”

Two developments may help increase use of buprenorphine, the study authors wrote. One is a recent study showing lower risk of adverse neonatal outcomes when buprenorphine is used during pregnancy compared with methadone. Another is the removal last year of the prescribing waiver for buprenorphine.
 

Study Included Medicaid Data Over 18 Years

The population-based cohort study used data from publicly insured Medicaid beneficiaries from 2000 to 2018. Pregnancies with enrollment from 90 days before pregnancy through 1 month after delivery and first-trimester use of buprenorphine or methadone were included (n = 13,360). The data were linked with infants’ health data.

The study group included 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure. The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone.

Major malformations were any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, oral clefts, and clubfoot.
 

Two Invited Commentaries Urge Caution in Interpretation

The two invited commentaries Dr. Grady mentioned in her editor’s note point both to the importance of the team’s findings and the need for better understanding of factors that may affect the choice of which OUD medication to use.

A commentary by Max Jordan Nguemeni Tiako, MD, MS, with the Department of Medicine, Brigham and Women’s Hospital, and colleagues, said that while the Suarez et al. data are important to share with patients, “the ultimate treatment decision must be the result of shared decision-making between a knowledgeable clinician and the patient, rather than promoting one medication over another.”

They urge putting the findings in context given the study population, which comprises a relatively stable group of women with OUD, most of whom were taking OUD medications before they got pregnant. The study sample excludes a substantial number of women who are chronically underinsured or uninsured, Dr. Tiako’s team wrote, because those included were enrolled in Medicaid for 3 consecutive months before pregnancy.

“We urge caution when extrapolating these findings to newly pregnant individuals with untreated OUD,” they wrote.
 

 

 

Both Medications are Safe

Cara Poland, MD, MEd, with the Henry Ford Health + Michigan State University Health Sciences in Grand Rapids, and coauthors, added in another commentary that Suarez et al. didn’t include a comparison between the population-level congenital defect rate and the defect rate for people using medications for OUD in pregnancy.

That comparison, they wrote, would have better illustrated the safety of medications for OUD “instead of simply comparing two medications with long-standing safety data.”

When a clinician starts a woman on medication for OUD in pregnancy, it’s important to understand several factors, including individual access to and comfort with different treatment approaches, they noted. It’s also important to weigh whether changing medications is worth the potential drawbacks of disrupting their well-managed care.

They wrote that the paper by Suarez et al. does not make the case for switching medications based on their findings.

Internists, they added, are ideal experts to explain risk of fetal abnormalities in the wider context of supporting engagement with continuous medication for OUD.

“In the absence of other concerns, switching medications (methadone to buprenorphine) or — worse — discontinuing [medication for] OUD because of this study runs counter to the substantial evidence regarding the safety of these medications during pregnancy,” Dr. Poland’s team wrote. “No treatment is without risk in pregnancy.”

This study was supported by the National Institute on Drug Abuse. In the Suarez et al. study, coauthors Dr. Hernández-Díaz, Dr. Gray, Dr. Connery, Dr. Zhu, and Dr. Huybrechts reported grants, personal fees and consulting payments from several pharmaceutical companies. Dr. Grady reports no relevant financial relationships in her editor’s note. No relevant financial relationships were reported by authors of the Tiako et al. commentary.

Regarding the commentary by Poland et al., grants were reported from the Michigan Health Endowment Fund, the Michigan Department of Health and Human Services, the National Institute on Drug Abuse and Blue Cross Blue Shield of Michigan outside the submitted work. No other disclosures were reported.

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Buprenorphine use, compared with methadone use, in pregnancy has been linked with a slightly lower risk of major congenital malformations in a new study of medications for opioid use disorder (OUD).

Elizabeth A. Suarez, PhD, MPH, with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues published the findings in JAMA Internal Medicine.

The lower risk for buprenorphine was small (risk ratio, 0.82; 95% confidence interval [CI], 0.69-0.97), and methadone use should not be ruled out on that basis, the authors wrote. For some women, particularly those on stable treatment before pregnancy or women who do not respond well to buprenorphine, methadone may be the better choice, they explained.
 

Either Medication Better Than Not Treating

The authors noted that either medication “is strongly recommended over untreated OUD during pregnancy.”

JAMA Internal Medicine Deputy Editor Deborah Grady, MD, MPH, with the Department of Medicine, University of California, San Francisco, emphasized that recommendation in an editor’s note, highlighting that treatment for OUD is critical to prevent infections, overdose, and death in pregnant women as well as neonatal opioid withdrawal syndrome and fetal death.

She stressed that internists and other primary care physicians have a key role in ensuring pregnant women with OUD receive appropriate treatment.

Given the importance of the issue, she wrote, “we have taken the unusual step of publishing two accompanying invited commentaries.”

Two developments may help increase use of buprenorphine, the study authors wrote. One is a recent study showing lower risk of adverse neonatal outcomes when buprenorphine is used during pregnancy compared with methadone. Another is the removal last year of the prescribing waiver for buprenorphine.
 

Study Included Medicaid Data Over 18 Years

The population-based cohort study used data from publicly insured Medicaid beneficiaries from 2000 to 2018. Pregnancies with enrollment from 90 days before pregnancy through 1 month after delivery and first-trimester use of buprenorphine or methadone were included (n = 13,360). The data were linked with infants’ health data.

The study group included 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure. The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone.

Major malformations were any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, oral clefts, and clubfoot.
 

Two Invited Commentaries Urge Caution in Interpretation

The two invited commentaries Dr. Grady mentioned in her editor’s note point both to the importance of the team’s findings and the need for better understanding of factors that may affect the choice of which OUD medication to use.

A commentary by Max Jordan Nguemeni Tiako, MD, MS, with the Department of Medicine, Brigham and Women’s Hospital, and colleagues, said that while the Suarez et al. data are important to share with patients, “the ultimate treatment decision must be the result of shared decision-making between a knowledgeable clinician and the patient, rather than promoting one medication over another.”

They urge putting the findings in context given the study population, which comprises a relatively stable group of women with OUD, most of whom were taking OUD medications before they got pregnant. The study sample excludes a substantial number of women who are chronically underinsured or uninsured, Dr. Tiako’s team wrote, because those included were enrolled in Medicaid for 3 consecutive months before pregnancy.

“We urge caution when extrapolating these findings to newly pregnant individuals with untreated OUD,” they wrote.
 

 

 

Both Medications are Safe

Cara Poland, MD, MEd, with the Henry Ford Health + Michigan State University Health Sciences in Grand Rapids, and coauthors, added in another commentary that Suarez et al. didn’t include a comparison between the population-level congenital defect rate and the defect rate for people using medications for OUD in pregnancy.

That comparison, they wrote, would have better illustrated the safety of medications for OUD “instead of simply comparing two medications with long-standing safety data.”

When a clinician starts a woman on medication for OUD in pregnancy, it’s important to understand several factors, including individual access to and comfort with different treatment approaches, they noted. It’s also important to weigh whether changing medications is worth the potential drawbacks of disrupting their well-managed care.

They wrote that the paper by Suarez et al. does not make the case for switching medications based on their findings.

Internists, they added, are ideal experts to explain risk of fetal abnormalities in the wider context of supporting engagement with continuous medication for OUD.

“In the absence of other concerns, switching medications (methadone to buprenorphine) or — worse — discontinuing [medication for] OUD because of this study runs counter to the substantial evidence regarding the safety of these medications during pregnancy,” Dr. Poland’s team wrote. “No treatment is without risk in pregnancy.”

This study was supported by the National Institute on Drug Abuse. In the Suarez et al. study, coauthors Dr. Hernández-Díaz, Dr. Gray, Dr. Connery, Dr. Zhu, and Dr. Huybrechts reported grants, personal fees and consulting payments from several pharmaceutical companies. Dr. Grady reports no relevant financial relationships in her editor’s note. No relevant financial relationships were reported by authors of the Tiako et al. commentary.

Regarding the commentary by Poland et al., grants were reported from the Michigan Health Endowment Fund, the Michigan Department of Health and Human Services, the National Institute on Drug Abuse and Blue Cross Blue Shield of Michigan outside the submitted work. No other disclosures were reported.

Buprenorphine use, compared with methadone use, in pregnancy has been linked with a slightly lower risk of major congenital malformations in a new study of medications for opioid use disorder (OUD).

Elizabeth A. Suarez, PhD, MPH, with the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues published the findings in JAMA Internal Medicine.

The lower risk for buprenorphine was small (risk ratio, 0.82; 95% confidence interval [CI], 0.69-0.97), and methadone use should not be ruled out on that basis, the authors wrote. For some women, particularly those on stable treatment before pregnancy or women who do not respond well to buprenorphine, methadone may be the better choice, they explained.
 

Either Medication Better Than Not Treating

The authors noted that either medication “is strongly recommended over untreated OUD during pregnancy.”

JAMA Internal Medicine Deputy Editor Deborah Grady, MD, MPH, with the Department of Medicine, University of California, San Francisco, emphasized that recommendation in an editor’s note, highlighting that treatment for OUD is critical to prevent infections, overdose, and death in pregnant women as well as neonatal opioid withdrawal syndrome and fetal death.

She stressed that internists and other primary care physicians have a key role in ensuring pregnant women with OUD receive appropriate treatment.

Given the importance of the issue, she wrote, “we have taken the unusual step of publishing two accompanying invited commentaries.”

Two developments may help increase use of buprenorphine, the study authors wrote. One is a recent study showing lower risk of adverse neonatal outcomes when buprenorphine is used during pregnancy compared with methadone. Another is the removal last year of the prescribing waiver for buprenorphine.
 

Study Included Medicaid Data Over 18 Years

The population-based cohort study used data from publicly insured Medicaid beneficiaries from 2000 to 2018. Pregnancies with enrollment from 90 days before pregnancy through 1 month after delivery and first-trimester use of buprenorphine or methadone were included (n = 13,360). The data were linked with infants’ health data.

The study group included 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure. The risk of malformations overall was 50.9 (95% CI, 46.5-55.3) per 1000 pregnancies for buprenorphine and 60.6 (95% CI, 53.0-68.1) per 1000 pregnancies for methadone.

Major malformations were any cardiac malformations, ventricular septal defect, secundum atrial septal defect/nonprematurity-related patent foramen ovale, neural tube defects, oral clefts, and clubfoot.
 

Two Invited Commentaries Urge Caution in Interpretation

The two invited commentaries Dr. Grady mentioned in her editor’s note point both to the importance of the team’s findings and the need for better understanding of factors that may affect the choice of which OUD medication to use.

A commentary by Max Jordan Nguemeni Tiako, MD, MS, with the Department of Medicine, Brigham and Women’s Hospital, and colleagues, said that while the Suarez et al. data are important to share with patients, “the ultimate treatment decision must be the result of shared decision-making between a knowledgeable clinician and the patient, rather than promoting one medication over another.”

They urge putting the findings in context given the study population, which comprises a relatively stable group of women with OUD, most of whom were taking OUD medications before they got pregnant. The study sample excludes a substantial number of women who are chronically underinsured or uninsured, Dr. Tiako’s team wrote, because those included were enrolled in Medicaid for 3 consecutive months before pregnancy.

“We urge caution when extrapolating these findings to newly pregnant individuals with untreated OUD,” they wrote.
 

 

 

Both Medications are Safe

Cara Poland, MD, MEd, with the Henry Ford Health + Michigan State University Health Sciences in Grand Rapids, and coauthors, added in another commentary that Suarez et al. didn’t include a comparison between the population-level congenital defect rate and the defect rate for people using medications for OUD in pregnancy.

That comparison, they wrote, would have better illustrated the safety of medications for OUD “instead of simply comparing two medications with long-standing safety data.”

When a clinician starts a woman on medication for OUD in pregnancy, it’s important to understand several factors, including individual access to and comfort with different treatment approaches, they noted. It’s also important to weigh whether changing medications is worth the potential drawbacks of disrupting their well-managed care.

They wrote that the paper by Suarez et al. does not make the case for switching medications based on their findings.

Internists, they added, are ideal experts to explain risk of fetal abnormalities in the wider context of supporting engagement with continuous medication for OUD.

“In the absence of other concerns, switching medications (methadone to buprenorphine) or — worse — discontinuing [medication for] OUD because of this study runs counter to the substantial evidence regarding the safety of these medications during pregnancy,” Dr. Poland’s team wrote. “No treatment is without risk in pregnancy.”

This study was supported by the National Institute on Drug Abuse. In the Suarez et al. study, coauthors Dr. Hernández-Díaz, Dr. Gray, Dr. Connery, Dr. Zhu, and Dr. Huybrechts reported grants, personal fees and consulting payments from several pharmaceutical companies. Dr. Grady reports no relevant financial relationships in her editor’s note. No relevant financial relationships were reported by authors of the Tiako et al. commentary.

Regarding the commentary by Poland et al., grants were reported from the Michigan Health Endowment Fund, the Michigan Department of Health and Human Services, the National Institute on Drug Abuse and Blue Cross Blue Shield of Michigan outside the submitted work. No other disclosures were reported.

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Novel Clinic Resulted in ‘Impressive’ Outcomes for Patients With Moderate to Severe Eczema

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A clinic aimed at managing patients with difficult-to-control atopic dermatitis (AD) by involving assessments from a team of clinicians from different disciplines led to significant improvements in severity of the disease, results from a single-center study showed.

“A significant challenge in caring for patients with atopic dermatitis is lack of collaboration between healthcare providers, leading to disjointed care, inconsistent treatment plans, and conflicting dialogue with patients,” first author Alexis Tracy, MD, a combined allergy and dermatology research fellow at Rady Children’s Hospital, San Diego, and colleagues wrote in the study, which was published online January 14, 2024, in Pediatric Dermatology.

Launched in 2019, the clinic, which is called the Multidisciplinary Atopic Dermatitis Program (MADP), is a collaborative effort between with Rady Children’s Hospital and the University of California San Diego Health division of dermatology, division of allergy & immunology, and the hospital’s clinical pharmacy. Patients referred to the MADP undergo a concurrent, comprehensive evaluation by a dermatologist, allergist, clinical pharmacist, and others who help to assess AD severity, provide family education about the disease, and form a care plan using the model of shared decision-making (SDM). Visits take about two hours, and the frequency of follow-up visits varies.

Courtesy Rady Children's Hospital
Core members of the Rady/UCSD Multidisciplinary Atopic Dermatitis Program are, from left, Dr. Lawrence Eichenfield (dermatology), Lauren Loop (research coordinator), Alyssa Wu (clinical pharmacist), Dr. Bob Geng (allergy), Katie Smiley (physician assistant and clinic cooordinator), and Dr. Mira Choi (visiting scholar).

In the dermatology realm, tools used to compare the extent and severity of AD between visits include the Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and the Numerical Rating Scale (NRS).To investigate the MADP’s success to date, Dr. Tracy and colleagues evaluated 44 patients with a history of moderate to severe, persistent AD who were referred to the clinic between April 3, 2019, and October 22, 2022, and had between one and three follow-up visits. The patients ranged from age 4 months to 18 years (mean, 7.74 years).

Compared with baseline, EASI scores of patients decreased significantly, with an average mean improvement of 9.61 by the second visit, 15.12 by the third visit, and 17.42 by the fourth visit (P <.001 for all three). These represent an average decreases of 44.20%, 63.26%, 74.35%, respectively.

At the seventh visit, the EASI score decreased by a mean of 33.48 (P = .008), which represents an average decrease of 91.52% from baseline. Of the 44 patients, 32 achieved an EASI 50 and 21 achieved an EASI 75.



In other findings, the mean vIGA improved with each visit, with the largest observed improvement at the seventh visit (a mean of 2.25 points; P = .009) and the greatest mean improvement in the POEM score was seen at the sixth visit (a mean of 11.13 points; P < .001). The mean difference in CDLQI scores also increased with each visit, with the largest improvement seen at the sixth visit (an increase of 12 points; P < .001).

Similarly, BSA progressively improved at each clinic visit, from a mean decrease of 16.02% at the second visit to a mean decrease of 56.04% at the seventh visit (P < .001 for both). Meanwhile, the largest mean improvement in pruritus was seen at the sixth visit (a mean of 4.10 points; P = .001).

In an interview, MADP’s codirector, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, said that the consistency of data showing rapid, consistent improvement with a varied set of physician assessed scores and patient-reported outcomes “was very impressive, especially given the variation in severity, extent and difficult course of many of the patients we saw, and spectrum of interventions – from topical regimens to advanced systemic therapies,” he said. “As clinicians we tend to remember the ‘tough cases,’ and it was tremendous to see the impact and utility of the clinic.”

Courtesy University of California, San Diego
Dr. Lawrence F. Eichenfield


He noted that he and Bob Geng, MD, an allergist/immunologist at Rady Children’s who co-directs the MADP, regularly discuss how much they have learned from the program. “Some take-aways are simple, like ‘do body surface area assessment in pediatric patients with moderate to serve atopic dermatitis,’ ” Dr. Eichenfield said. “These help us show the severity to the patient and family, and everyone loves to see the objective improvement measures over time.”

The MADP providers and personnel have become better at explaining AD “and understanding how families come in with broad differences in understanding of the disease, therapies and prior treatments,” he added. “And I have learned that discussing environmental allergies and food allergies, even if they might not be triggers of the AD, is appreciated by patients and families, as they are part of the family experience and they appreciate our ‘broadly caring’ beyond our narrow niches of intervention.”


 
 

 

Important model of care

Asked to comment on the results, pediatric dermatologist Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, who was not involved with the study, characterized the MADP as an important model of care. “Multi-interdisciplinary care of such conditions is well-known to be of great help for patients and their families,” he told this news organization.

Dr. Moise L. Levy

“A key part of the ‘team’ is the family/patient engagement and shared decision-making. The use of visual aides to highlight components of care was likely of great use, as well,” he said. “All such interventions impact the disease, as well as associated problems, such as itch, sleep, and mental health. Importantly, such interventions, while known to be useful as demonstrated by the authors, take time, and relate to improved outcomes as noted by the date outlined by the authors.”

The study authors acknowledged certain limitations of the study, including the lack of a control group with single-specialty visits. “The real take-away is that taking the time to do more holistic assessments of health — with skin and allergy issues being discussed, and consistent education and messaging — helps make our medical interventions more successful, with both objective disease improvement and patient/family satisfaction,” Dr. Eichenfield said in the interview.

Pfizer and Sanofi provided financial support to MADP, and for the study. Dr. Eichenfield disclosed that he serves as a scientific adviser, consultant, and/or clinical trial investigator for AbbVie, Amgen, Aslan, Castle Biosciences, Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Trialspark, and UCB. Dr. Geng disclosed ties with Sanofi, Regeneron, Pfizer, and AbbVie, and is an adviser to Incyte, Galderma, Eli-Lilly, and LEO. The other authors reported having no disclosures. Dr. Levy disclosed ties with Abeona, Amgen, Arcutis, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. He is also an investigator for Janssen.

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A clinic aimed at managing patients with difficult-to-control atopic dermatitis (AD) by involving assessments from a team of clinicians from different disciplines led to significant improvements in severity of the disease, results from a single-center study showed.

“A significant challenge in caring for patients with atopic dermatitis is lack of collaboration between healthcare providers, leading to disjointed care, inconsistent treatment plans, and conflicting dialogue with patients,” first author Alexis Tracy, MD, a combined allergy and dermatology research fellow at Rady Children’s Hospital, San Diego, and colleagues wrote in the study, which was published online January 14, 2024, in Pediatric Dermatology.

Launched in 2019, the clinic, which is called the Multidisciplinary Atopic Dermatitis Program (MADP), is a collaborative effort between with Rady Children’s Hospital and the University of California San Diego Health division of dermatology, division of allergy & immunology, and the hospital’s clinical pharmacy. Patients referred to the MADP undergo a concurrent, comprehensive evaluation by a dermatologist, allergist, clinical pharmacist, and others who help to assess AD severity, provide family education about the disease, and form a care plan using the model of shared decision-making (SDM). Visits take about two hours, and the frequency of follow-up visits varies.

Courtesy Rady Children&#039;s Hospital
Core members of the Rady/UCSD Multidisciplinary Atopic Dermatitis Program are, from left, Dr. Lawrence Eichenfield (dermatology), Lauren Loop (research coordinator), Alyssa Wu (clinical pharmacist), Dr. Bob Geng (allergy), Katie Smiley (physician assistant and clinic cooordinator), and Dr. Mira Choi (visiting scholar).

In the dermatology realm, tools used to compare the extent and severity of AD between visits include the Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and the Numerical Rating Scale (NRS).To investigate the MADP’s success to date, Dr. Tracy and colleagues evaluated 44 patients with a history of moderate to severe, persistent AD who were referred to the clinic between April 3, 2019, and October 22, 2022, and had between one and three follow-up visits. The patients ranged from age 4 months to 18 years (mean, 7.74 years).

Compared with baseline, EASI scores of patients decreased significantly, with an average mean improvement of 9.61 by the second visit, 15.12 by the third visit, and 17.42 by the fourth visit (P <.001 for all three). These represent an average decreases of 44.20%, 63.26%, 74.35%, respectively.

At the seventh visit, the EASI score decreased by a mean of 33.48 (P = .008), which represents an average decrease of 91.52% from baseline. Of the 44 patients, 32 achieved an EASI 50 and 21 achieved an EASI 75.



In other findings, the mean vIGA improved with each visit, with the largest observed improvement at the seventh visit (a mean of 2.25 points; P = .009) and the greatest mean improvement in the POEM score was seen at the sixth visit (a mean of 11.13 points; P < .001). The mean difference in CDLQI scores also increased with each visit, with the largest improvement seen at the sixth visit (an increase of 12 points; P < .001).

Similarly, BSA progressively improved at each clinic visit, from a mean decrease of 16.02% at the second visit to a mean decrease of 56.04% at the seventh visit (P < .001 for both). Meanwhile, the largest mean improvement in pruritus was seen at the sixth visit (a mean of 4.10 points; P = .001).

In an interview, MADP’s codirector, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, said that the consistency of data showing rapid, consistent improvement with a varied set of physician assessed scores and patient-reported outcomes “was very impressive, especially given the variation in severity, extent and difficult course of many of the patients we saw, and spectrum of interventions – from topical regimens to advanced systemic therapies,” he said. “As clinicians we tend to remember the ‘tough cases,’ and it was tremendous to see the impact and utility of the clinic.”

Courtesy University of California, San Diego
Dr. Lawrence F. Eichenfield


He noted that he and Bob Geng, MD, an allergist/immunologist at Rady Children’s who co-directs the MADP, regularly discuss how much they have learned from the program. “Some take-aways are simple, like ‘do body surface area assessment in pediatric patients with moderate to serve atopic dermatitis,’ ” Dr. Eichenfield said. “These help us show the severity to the patient and family, and everyone loves to see the objective improvement measures over time.”

The MADP providers and personnel have become better at explaining AD “and understanding how families come in with broad differences in understanding of the disease, therapies and prior treatments,” he added. “And I have learned that discussing environmental allergies and food allergies, even if they might not be triggers of the AD, is appreciated by patients and families, as they are part of the family experience and they appreciate our ‘broadly caring’ beyond our narrow niches of intervention.”


 
 

 

Important model of care

Asked to comment on the results, pediatric dermatologist Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, who was not involved with the study, characterized the MADP as an important model of care. “Multi-interdisciplinary care of such conditions is well-known to be of great help for patients and their families,” he told this news organization.

Dr. Moise L. Levy

“A key part of the ‘team’ is the family/patient engagement and shared decision-making. The use of visual aides to highlight components of care was likely of great use, as well,” he said. “All such interventions impact the disease, as well as associated problems, such as itch, sleep, and mental health. Importantly, such interventions, while known to be useful as demonstrated by the authors, take time, and relate to improved outcomes as noted by the date outlined by the authors.”

The study authors acknowledged certain limitations of the study, including the lack of a control group with single-specialty visits. “The real take-away is that taking the time to do more holistic assessments of health — with skin and allergy issues being discussed, and consistent education and messaging — helps make our medical interventions more successful, with both objective disease improvement and patient/family satisfaction,” Dr. Eichenfield said in the interview.

Pfizer and Sanofi provided financial support to MADP, and for the study. Dr. Eichenfield disclosed that he serves as a scientific adviser, consultant, and/or clinical trial investigator for AbbVie, Amgen, Aslan, Castle Biosciences, Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Trialspark, and UCB. Dr. Geng disclosed ties with Sanofi, Regeneron, Pfizer, and AbbVie, and is an adviser to Incyte, Galderma, Eli-Lilly, and LEO. The other authors reported having no disclosures. Dr. Levy disclosed ties with Abeona, Amgen, Arcutis, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. He is also an investigator for Janssen.

A clinic aimed at managing patients with difficult-to-control atopic dermatitis (AD) by involving assessments from a team of clinicians from different disciplines led to significant improvements in severity of the disease, results from a single-center study showed.

“A significant challenge in caring for patients with atopic dermatitis is lack of collaboration between healthcare providers, leading to disjointed care, inconsistent treatment plans, and conflicting dialogue with patients,” first author Alexis Tracy, MD, a combined allergy and dermatology research fellow at Rady Children’s Hospital, San Diego, and colleagues wrote in the study, which was published online January 14, 2024, in Pediatric Dermatology.

Launched in 2019, the clinic, which is called the Multidisciplinary Atopic Dermatitis Program (MADP), is a collaborative effort between with Rady Children’s Hospital and the University of California San Diego Health division of dermatology, division of allergy & immunology, and the hospital’s clinical pharmacy. Patients referred to the MADP undergo a concurrent, comprehensive evaluation by a dermatologist, allergist, clinical pharmacist, and others who help to assess AD severity, provide family education about the disease, and form a care plan using the model of shared decision-making (SDM). Visits take about two hours, and the frequency of follow-up visits varies.

Courtesy Rady Children&#039;s Hospital
Core members of the Rady/UCSD Multidisciplinary Atopic Dermatitis Program are, from left, Dr. Lawrence Eichenfield (dermatology), Lauren Loop (research coordinator), Alyssa Wu (clinical pharmacist), Dr. Bob Geng (allergy), Katie Smiley (physician assistant and clinic cooordinator), and Dr. Mira Choi (visiting scholar).

In the dermatology realm, tools used to compare the extent and severity of AD between visits include the Eczema Area and Severity Index (EASI), Patient-Oriented Eczema Measure (POEM), the Children’s Dermatology Life Quality Index (CDLQI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and the Numerical Rating Scale (NRS).To investigate the MADP’s success to date, Dr. Tracy and colleagues evaluated 44 patients with a history of moderate to severe, persistent AD who were referred to the clinic between April 3, 2019, and October 22, 2022, and had between one and three follow-up visits. The patients ranged from age 4 months to 18 years (mean, 7.74 years).

Compared with baseline, EASI scores of patients decreased significantly, with an average mean improvement of 9.61 by the second visit, 15.12 by the third visit, and 17.42 by the fourth visit (P <.001 for all three). These represent an average decreases of 44.20%, 63.26%, 74.35%, respectively.

At the seventh visit, the EASI score decreased by a mean of 33.48 (P = .008), which represents an average decrease of 91.52% from baseline. Of the 44 patients, 32 achieved an EASI 50 and 21 achieved an EASI 75.



In other findings, the mean vIGA improved with each visit, with the largest observed improvement at the seventh visit (a mean of 2.25 points; P = .009) and the greatest mean improvement in the POEM score was seen at the sixth visit (a mean of 11.13 points; P < .001). The mean difference in CDLQI scores also increased with each visit, with the largest improvement seen at the sixth visit (an increase of 12 points; P < .001).

Similarly, BSA progressively improved at each clinic visit, from a mean decrease of 16.02% at the second visit to a mean decrease of 56.04% at the seventh visit (P < .001 for both). Meanwhile, the largest mean improvement in pruritus was seen at the sixth visit (a mean of 4.10 points; P = .001).

In an interview, MADP’s codirector, Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, said that the consistency of data showing rapid, consistent improvement with a varied set of physician assessed scores and patient-reported outcomes “was very impressive, especially given the variation in severity, extent and difficult course of many of the patients we saw, and spectrum of interventions – from topical regimens to advanced systemic therapies,” he said. “As clinicians we tend to remember the ‘tough cases,’ and it was tremendous to see the impact and utility of the clinic.”

Courtesy University of California, San Diego
Dr. Lawrence F. Eichenfield


He noted that he and Bob Geng, MD, an allergist/immunologist at Rady Children’s who co-directs the MADP, regularly discuss how much they have learned from the program. “Some take-aways are simple, like ‘do body surface area assessment in pediatric patients with moderate to serve atopic dermatitis,’ ” Dr. Eichenfield said. “These help us show the severity to the patient and family, and everyone loves to see the objective improvement measures over time.”

The MADP providers and personnel have become better at explaining AD “and understanding how families come in with broad differences in understanding of the disease, therapies and prior treatments,” he added. “And I have learned that discussing environmental allergies and food allergies, even if they might not be triggers of the AD, is appreciated by patients and families, as they are part of the family experience and they appreciate our ‘broadly caring’ beyond our narrow niches of intervention.”


 
 

 

Important model of care

Asked to comment on the results, pediatric dermatologist Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, who was not involved with the study, characterized the MADP as an important model of care. “Multi-interdisciplinary care of such conditions is well-known to be of great help for patients and their families,” he told this news organization.

Dr. Moise L. Levy

“A key part of the ‘team’ is the family/patient engagement and shared decision-making. The use of visual aides to highlight components of care was likely of great use, as well,” he said. “All such interventions impact the disease, as well as associated problems, such as itch, sleep, and mental health. Importantly, such interventions, while known to be useful as demonstrated by the authors, take time, and relate to improved outcomes as noted by the date outlined by the authors.”

The study authors acknowledged certain limitations of the study, including the lack of a control group with single-specialty visits. “The real take-away is that taking the time to do more holistic assessments of health — with skin and allergy issues being discussed, and consistent education and messaging — helps make our medical interventions more successful, with both objective disease improvement and patient/family satisfaction,” Dr. Eichenfield said in the interview.

Pfizer and Sanofi provided financial support to MADP, and for the study. Dr. Eichenfield disclosed that he serves as a scientific adviser, consultant, and/or clinical trial investigator for AbbVie, Amgen, Aslan, Castle Biosciences, Dermavant, Eli Lilly and Company, Forté, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi-Genzyme, Trialspark, and UCB. Dr. Geng disclosed ties with Sanofi, Regeneron, Pfizer, and AbbVie, and is an adviser to Incyte, Galderma, Eli-Lilly, and LEO. The other authors reported having no disclosures. Dr. Levy disclosed ties with Abeona, Amgen, Arcutis, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. He is also an investigator for Janssen.

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Why Don’t Physicians Call In Sick?

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I began practicing medicine on July 1, 1981. In the 43-plus years since then, I have not missed a single day in the office because of illness. Does that mean I have never been sick? Of course not. I have simply never felt that I was sick enough to warrant staying home.

There are several reasons, both good and bad, why this is so: (1) like most physicians, I am a terrible patient; (2) as a solo practitioner, there was (until recently — I’ll get to that in a minute) no one else to see an office full of patients who had waited significant amounts of time for their appointments and in many cases had taken off work themselves to keep them; and (3) there is an unspoken rule against it. Taking sick days is highly frowned upon in the medical world. As a medical student, intern, and resident I was told in so many words not to call in sick, no matter how serious the illness might be.

Dr. Joseph S. Eastern

Apparently, I was not the only doctor-in-training to receive that message. In a survey reported in JAMA Pediatrics several years ago, 95% of the physicians and advanced practice clinicians (APCs) surveyed believed that working while sick put patients at risk — yet 83% reported working sick at least one time over the prior year. They understood the risks, but did it anyway.

There is no question that this practice does put patients’ health at risk. The JAMA study linked numerous reports of outbreaks traceable to symptomatic healthcare workers. Some outbreaks of flu, staph infections, norovirus, and pertussis were shown to originate from a sick physician or supporting staff member. These associations have led to increased morbidity and mortality, as well as excess costs. Those of us who treat immunocompromised patients on a regular basis risk inducing a life-threatening illness by unnecessarily exposing them to pathogens.

The JAMA survey results also confirmed my own observation that many physicians feel boxed in by their institutions or practice situations. “The study illustrates the complex social and logistic factors that cause this behavior,” the authors wrote. “These results may inform efforts to design systems at our hospital to provide support for attending physicians and APCs and help them make the right choice to keep their patients and colleagues safe while caring for themselves.” 

What might those efforts look like? For one thing, we can take the obvious and necessary steps to avoid getting sick in the first place, such as staying fit and hydrated, and eating well. We can keep up with routine health visits and measures such as colorectal screening, pap smears, and mammograms, and stay up to date with flu shots and all other essential immunizations.

Next, we can minimize the risk of spreading any illnesses we encounter in the course of our work by practicing the basic infectious disease prevention measures driven home so forcefully by the recent COVID-19 pandemic — washing our hands, using hand sanitizers, and, when appropriate, wearing gloves and masks.



Finally, we can work to overcome this institutional taboo against staying home when we do get sick. Work out a system of mutual coverage for such situations. Two years ago, I merged my solo practice with a local, larger group. I did it for a variety of reasons, but a principal one was to assure that a partner could cover for me if I became ill. Practitioners who choose to remain solo or in small groups should contact colleagues and work out a coverage agreement.

Now, during flu season, it is especially important to resist the temptation to work while sick. The CDC has guidelines for employees specific for the flu, which notes that “persons with the flu are most contagious during the first 3 days of their illness,” and should remain at home until at least 24 hours after their fever subsides (without the use of fever-reducing medications) or after symptoms have improved (at least 4-5 days after they started) — or, if they do not have a fever, after symptoms improve “for at least 4-5 days after the onset of symptoms.”

Of course, we need to remember that COVID-19 is still with us. With the constant evolution of new strains, it is especially important to avoid exposing patients and colleagues to the disease should you become infected. The most recent advice from the CDC includes the recommendation that those who are mildly ill and not moderately or severely immunocompromised should isolate after SARS-CoV-2 infection for at least 5 days after symptom onset (day 0 is the day symptoms appeared, and day 1 is the next full day thereafter) if fever has resolved for at least 24 hours (without taking fever-reducing medications) and other symptoms are improving. In addition, “a high-quality mask should be worn around others at home and in public through day 10.”

We should also extend these rules to our support staff, starting with providing them with adequate sick leave and encouraging them to use it when necessary. Research has found a direct correlation between preventative health care and the number of paid sick leave days a worker gets. In a study of over 3000 US workers, those with 10 paid sick days or more annually accessed preventative care more frequently than those without paid sick days.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

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I began practicing medicine on July 1, 1981. In the 43-plus years since then, I have not missed a single day in the office because of illness. Does that mean I have never been sick? Of course not. I have simply never felt that I was sick enough to warrant staying home.

There are several reasons, both good and bad, why this is so: (1) like most physicians, I am a terrible patient; (2) as a solo practitioner, there was (until recently — I’ll get to that in a minute) no one else to see an office full of patients who had waited significant amounts of time for their appointments and in many cases had taken off work themselves to keep them; and (3) there is an unspoken rule against it. Taking sick days is highly frowned upon in the medical world. As a medical student, intern, and resident I was told in so many words not to call in sick, no matter how serious the illness might be.

Dr. Joseph S. Eastern

Apparently, I was not the only doctor-in-training to receive that message. In a survey reported in JAMA Pediatrics several years ago, 95% of the physicians and advanced practice clinicians (APCs) surveyed believed that working while sick put patients at risk — yet 83% reported working sick at least one time over the prior year. They understood the risks, but did it anyway.

There is no question that this practice does put patients’ health at risk. The JAMA study linked numerous reports of outbreaks traceable to symptomatic healthcare workers. Some outbreaks of flu, staph infections, norovirus, and pertussis were shown to originate from a sick physician or supporting staff member. These associations have led to increased morbidity and mortality, as well as excess costs. Those of us who treat immunocompromised patients on a regular basis risk inducing a life-threatening illness by unnecessarily exposing them to pathogens.

The JAMA survey results also confirmed my own observation that many physicians feel boxed in by their institutions or practice situations. “The study illustrates the complex social and logistic factors that cause this behavior,” the authors wrote. “These results may inform efforts to design systems at our hospital to provide support for attending physicians and APCs and help them make the right choice to keep their patients and colleagues safe while caring for themselves.” 

What might those efforts look like? For one thing, we can take the obvious and necessary steps to avoid getting sick in the first place, such as staying fit and hydrated, and eating well. We can keep up with routine health visits and measures such as colorectal screening, pap smears, and mammograms, and stay up to date with flu shots and all other essential immunizations.

Next, we can minimize the risk of spreading any illnesses we encounter in the course of our work by practicing the basic infectious disease prevention measures driven home so forcefully by the recent COVID-19 pandemic — washing our hands, using hand sanitizers, and, when appropriate, wearing gloves and masks.



Finally, we can work to overcome this institutional taboo against staying home when we do get sick. Work out a system of mutual coverage for such situations. Two years ago, I merged my solo practice with a local, larger group. I did it for a variety of reasons, but a principal one was to assure that a partner could cover for me if I became ill. Practitioners who choose to remain solo or in small groups should contact colleagues and work out a coverage agreement.

Now, during flu season, it is especially important to resist the temptation to work while sick. The CDC has guidelines for employees specific for the flu, which notes that “persons with the flu are most contagious during the first 3 days of their illness,” and should remain at home until at least 24 hours after their fever subsides (without the use of fever-reducing medications) or after symptoms have improved (at least 4-5 days after they started) — or, if they do not have a fever, after symptoms improve “for at least 4-5 days after the onset of symptoms.”

Of course, we need to remember that COVID-19 is still with us. With the constant evolution of new strains, it is especially important to avoid exposing patients and colleagues to the disease should you become infected. The most recent advice from the CDC includes the recommendation that those who are mildly ill and not moderately or severely immunocompromised should isolate after SARS-CoV-2 infection for at least 5 days after symptom onset (day 0 is the day symptoms appeared, and day 1 is the next full day thereafter) if fever has resolved for at least 24 hours (without taking fever-reducing medications) and other symptoms are improving. In addition, “a high-quality mask should be worn around others at home and in public through day 10.”

We should also extend these rules to our support staff, starting with providing them with adequate sick leave and encouraging them to use it when necessary. Research has found a direct correlation between preventative health care and the number of paid sick leave days a worker gets. In a study of over 3000 US workers, those with 10 paid sick days or more annually accessed preventative care more frequently than those without paid sick days.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

I began practicing medicine on July 1, 1981. In the 43-plus years since then, I have not missed a single day in the office because of illness. Does that mean I have never been sick? Of course not. I have simply never felt that I was sick enough to warrant staying home.

There are several reasons, both good and bad, why this is so: (1) like most physicians, I am a terrible patient; (2) as a solo practitioner, there was (until recently — I’ll get to that in a minute) no one else to see an office full of patients who had waited significant amounts of time for their appointments and in many cases had taken off work themselves to keep them; and (3) there is an unspoken rule against it. Taking sick days is highly frowned upon in the medical world. As a medical student, intern, and resident I was told in so many words not to call in sick, no matter how serious the illness might be.

Dr. Joseph S. Eastern

Apparently, I was not the only doctor-in-training to receive that message. In a survey reported in JAMA Pediatrics several years ago, 95% of the physicians and advanced practice clinicians (APCs) surveyed believed that working while sick put patients at risk — yet 83% reported working sick at least one time over the prior year. They understood the risks, but did it anyway.

There is no question that this practice does put patients’ health at risk. The JAMA study linked numerous reports of outbreaks traceable to symptomatic healthcare workers. Some outbreaks of flu, staph infections, norovirus, and pertussis were shown to originate from a sick physician or supporting staff member. These associations have led to increased morbidity and mortality, as well as excess costs. Those of us who treat immunocompromised patients on a regular basis risk inducing a life-threatening illness by unnecessarily exposing them to pathogens.

The JAMA survey results also confirmed my own observation that many physicians feel boxed in by their institutions or practice situations. “The study illustrates the complex social and logistic factors that cause this behavior,” the authors wrote. “These results may inform efforts to design systems at our hospital to provide support for attending physicians and APCs and help them make the right choice to keep their patients and colleagues safe while caring for themselves.” 

What might those efforts look like? For one thing, we can take the obvious and necessary steps to avoid getting sick in the first place, such as staying fit and hydrated, and eating well. We can keep up with routine health visits and measures such as colorectal screening, pap smears, and mammograms, and stay up to date with flu shots and all other essential immunizations.

Next, we can minimize the risk of spreading any illnesses we encounter in the course of our work by practicing the basic infectious disease prevention measures driven home so forcefully by the recent COVID-19 pandemic — washing our hands, using hand sanitizers, and, when appropriate, wearing gloves and masks.



Finally, we can work to overcome this institutional taboo against staying home when we do get sick. Work out a system of mutual coverage for such situations. Two years ago, I merged my solo practice with a local, larger group. I did it for a variety of reasons, but a principal one was to assure that a partner could cover for me if I became ill. Practitioners who choose to remain solo or in small groups should contact colleagues and work out a coverage agreement.

Now, during flu season, it is especially important to resist the temptation to work while sick. The CDC has guidelines for employees specific for the flu, which notes that “persons with the flu are most contagious during the first 3 days of their illness,” and should remain at home until at least 24 hours after their fever subsides (without the use of fever-reducing medications) or after symptoms have improved (at least 4-5 days after they started) — or, if they do not have a fever, after symptoms improve “for at least 4-5 days after the onset of symptoms.”

Of course, we need to remember that COVID-19 is still with us. With the constant evolution of new strains, it is especially important to avoid exposing patients and colleagues to the disease should you become infected. The most recent advice from the CDC includes the recommendation that those who are mildly ill and not moderately or severely immunocompromised should isolate after SARS-CoV-2 infection for at least 5 days after symptom onset (day 0 is the day symptoms appeared, and day 1 is the next full day thereafter) if fever has resolved for at least 24 hours (without taking fever-reducing medications) and other symptoms are improving. In addition, “a high-quality mask should be worn around others at home and in public through day 10.”

We should also extend these rules to our support staff, starting with providing them with adequate sick leave and encouraging them to use it when necessary. Research has found a direct correlation between preventative health care and the number of paid sick leave days a worker gets. In a study of over 3000 US workers, those with 10 paid sick days or more annually accessed preventative care more frequently than those without paid sick days.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

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Vitamin D levels are lower in patients with eosinophilic esophagitis

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Key clinical point: The serum levels of vitamin D are significantly lower in patients with newly diagnosed eosinophilic esophagitis (EoE) than in control individuals without EoE; however, vitamin D levels are not strongly linked with the clinical, endoscopic, or histologic features of EoE.

Major finding: Mean serum 25-hydroxy-vitamin D3 levels were lower by 10.8 ng/mL in patients with EoE vs control individuals (95% CI −19.0 to −2.51). However, these levels were neither associated with differences in clinical or endoscopic features of EoE nor did they significantly correlate with EoE Endoscopic Reference Scores and eosinophil counts (Pearson’s R −0.28, P = .08; and −0.01, P = .93, respectively).

Study details: This secondary analysis of a prospective cohort study used the data of adults who underwent endoscopy and biopsy for upper gastrointestinal symptoms, of whom 40 were diagnosed with EoE and 40 were control individuals without EoE.

Disclosures: This study was supported by the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Cameron BA et al. Vitamin D levels as a potential modifier of eosinophilic esophagitis severity in adults. Dig Dis Sci. 2024 (Jan 6). doi: 10.1007/s10620-023-08264-x

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Key clinical point: The serum levels of vitamin D are significantly lower in patients with newly diagnosed eosinophilic esophagitis (EoE) than in control individuals without EoE; however, vitamin D levels are not strongly linked with the clinical, endoscopic, or histologic features of EoE.

Major finding: Mean serum 25-hydroxy-vitamin D3 levels were lower by 10.8 ng/mL in patients with EoE vs control individuals (95% CI −19.0 to −2.51). However, these levels were neither associated with differences in clinical or endoscopic features of EoE nor did they significantly correlate with EoE Endoscopic Reference Scores and eosinophil counts (Pearson’s R −0.28, P = .08; and −0.01, P = .93, respectively).

Study details: This secondary analysis of a prospective cohort study used the data of adults who underwent endoscopy and biopsy for upper gastrointestinal symptoms, of whom 40 were diagnosed with EoE and 40 were control individuals without EoE.

Disclosures: This study was supported by the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Cameron BA et al. Vitamin D levels as a potential modifier of eosinophilic esophagitis severity in adults. Dig Dis Sci. 2024 (Jan 6). doi: 10.1007/s10620-023-08264-x

Key clinical point: The serum levels of vitamin D are significantly lower in patients with newly diagnosed eosinophilic esophagitis (EoE) than in control individuals without EoE; however, vitamin D levels are not strongly linked with the clinical, endoscopic, or histologic features of EoE.

Major finding: Mean serum 25-hydroxy-vitamin D3 levels were lower by 10.8 ng/mL in patients with EoE vs control individuals (95% CI −19.0 to −2.51). However, these levels were neither associated with differences in clinical or endoscopic features of EoE nor did they significantly correlate with EoE Endoscopic Reference Scores and eosinophil counts (Pearson’s R −0.28, P = .08; and −0.01, P = .93, respectively).

Study details: This secondary analysis of a prospective cohort study used the data of adults who underwent endoscopy and biopsy for upper gastrointestinal symptoms, of whom 40 were diagnosed with EoE and 40 were control individuals without EoE.

Disclosures: This study was supported by the US National Institutes of Health. The authors declared no conflicts of interest.

Source: Cameron BA et al. Vitamin D levels as a potential modifier of eosinophilic esophagitis severity in adults. Dig Dis Sci. 2024 (Jan 6). doi: 10.1007/s10620-023-08264-x

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Allergic phenotypes may predict low response to proton-pump inhibitors in eosinophilic esophagitis

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Key clinical point: Patients with eosinophilic esophagitis (EoE) who test positive for food and environmental allergens may report a lower response to proton-pump inhibitor (PPI) treatment, a first-line treatment for EoE.

Major finding: Positive food allergen testing predicted lower odds of histologic response (adjusted odds ratio [aOR] 0.15; P = .0006) and symptom response (aOR 0.22; P = .03) to PPI therapy. Patients with a higher number of positive environmental allergens detected on skin-prick testing (≥10 vs <10) were less likely to respond to PPI (21.0% vs 53.9%; P = .03).

Study details: Findings are from a retrospective study including 61 adults with newly diagnosed EoE who underwent formal allergy testing for food and environmental allergens and received PPI therapy twice daily after EoE diagnosis.

Disclosures: The corresponding author WW Chan declared serving on the scientific advisory board for a several pharmaceutical companies.

Source: Muftah M et al. Allergic phenotype identified on allergen testing is associated with proton pump inhibitor nonresponse in eosinophilic esophagitis. J Gastroenterol Hepatol. 2024 (Jan 7). doi: 10.1111/jgh.16469

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Key clinical point: Patients with eosinophilic esophagitis (EoE) who test positive for food and environmental allergens may report a lower response to proton-pump inhibitor (PPI) treatment, a first-line treatment for EoE.

Major finding: Positive food allergen testing predicted lower odds of histologic response (adjusted odds ratio [aOR] 0.15; P = .0006) and symptom response (aOR 0.22; P = .03) to PPI therapy. Patients with a higher number of positive environmental allergens detected on skin-prick testing (≥10 vs <10) were less likely to respond to PPI (21.0% vs 53.9%; P = .03).

Study details: Findings are from a retrospective study including 61 adults with newly diagnosed EoE who underwent formal allergy testing for food and environmental allergens and received PPI therapy twice daily after EoE diagnosis.

Disclosures: The corresponding author WW Chan declared serving on the scientific advisory board for a several pharmaceutical companies.

Source: Muftah M et al. Allergic phenotype identified on allergen testing is associated with proton pump inhibitor nonresponse in eosinophilic esophagitis. J Gastroenterol Hepatol. 2024 (Jan 7). doi: 10.1111/jgh.16469

Key clinical point: Patients with eosinophilic esophagitis (EoE) who test positive for food and environmental allergens may report a lower response to proton-pump inhibitor (PPI) treatment, a first-line treatment for EoE.

Major finding: Positive food allergen testing predicted lower odds of histologic response (adjusted odds ratio [aOR] 0.15; P = .0006) and symptom response (aOR 0.22; P = .03) to PPI therapy. Patients with a higher number of positive environmental allergens detected on skin-prick testing (≥10 vs <10) were less likely to respond to PPI (21.0% vs 53.9%; P = .03).

Study details: Findings are from a retrospective study including 61 adults with newly diagnosed EoE who underwent formal allergy testing for food and environmental allergens and received PPI therapy twice daily after EoE diagnosis.

Disclosures: The corresponding author WW Chan declared serving on the scientific advisory board for a several pharmaceutical companies.

Source: Muftah M et al. Allergic phenotype identified on allergen testing is associated with proton pump inhibitor nonresponse in eosinophilic esophagitis. J Gastroenterol Hepatol. 2024 (Jan 7). doi: 10.1111/jgh.16469

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Histological categories do not help in predicting treatment response in eosinophilic esophagitis

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Key clinical point: Budesonide orodispersible tablet (BOT) induces clinicohistological remission irrespective of the distribution of esophageal eosinophilia. Histological categories are not predictors of treatment response in patients with eosinophilic esophagitis (EoE).

Major finding: Histological categories were not found to be significantly associated with treatment outcome (mid: adjusted odds ratio [aOR] 1.75; 95% CI 0.588-5.25; distal: aOR 1.42; 95% CI 0.535-3.60; diffuse: aOR 0.910; 95% CI 0.358-2.19).

Study details: This post hoc analysis of the phase 3 EOS-1 and EOS-2 trials included 263 patients with EoE having either proximal, mid, or distal esophagus predominant disease or diffuse disease who received a 6-week induction treatment with BOT.

Disclosures: This study was supported by the Swiss National Science Foundation and others. Some authors declared serving as consultants for or receiving speaker or consulting fees or travel grants from various sources.

Source: Godat A et al on behalf of the EoE eosinophil distribution research group. Eosinophil distribution in eosinophilic esophagitis and its impact on disease activity and response to treatment. Clin Gastroenterol Hepatol. 2023 (Dec 15). doi: 10.1016/j.cgh.2023.12.003

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Key clinical point: Budesonide orodispersible tablet (BOT) induces clinicohistological remission irrespective of the distribution of esophageal eosinophilia. Histological categories are not predictors of treatment response in patients with eosinophilic esophagitis (EoE).

Major finding: Histological categories were not found to be significantly associated with treatment outcome (mid: adjusted odds ratio [aOR] 1.75; 95% CI 0.588-5.25; distal: aOR 1.42; 95% CI 0.535-3.60; diffuse: aOR 0.910; 95% CI 0.358-2.19).

Study details: This post hoc analysis of the phase 3 EOS-1 and EOS-2 trials included 263 patients with EoE having either proximal, mid, or distal esophagus predominant disease or diffuse disease who received a 6-week induction treatment with BOT.

Disclosures: This study was supported by the Swiss National Science Foundation and others. Some authors declared serving as consultants for or receiving speaker or consulting fees or travel grants from various sources.

Source: Godat A et al on behalf of the EoE eosinophil distribution research group. Eosinophil distribution in eosinophilic esophagitis and its impact on disease activity and response to treatment. Clin Gastroenterol Hepatol. 2023 (Dec 15). doi: 10.1016/j.cgh.2023.12.003

Key clinical point: Budesonide orodispersible tablet (BOT) induces clinicohistological remission irrespective of the distribution of esophageal eosinophilia. Histological categories are not predictors of treatment response in patients with eosinophilic esophagitis (EoE).

Major finding: Histological categories were not found to be significantly associated with treatment outcome (mid: adjusted odds ratio [aOR] 1.75; 95% CI 0.588-5.25; distal: aOR 1.42; 95% CI 0.535-3.60; diffuse: aOR 0.910; 95% CI 0.358-2.19).

Study details: This post hoc analysis of the phase 3 EOS-1 and EOS-2 trials included 263 patients with EoE having either proximal, mid, or distal esophagus predominant disease or diffuse disease who received a 6-week induction treatment with BOT.

Disclosures: This study was supported by the Swiss National Science Foundation and others. Some authors declared serving as consultants for or receiving speaker or consulting fees or travel grants from various sources.

Source: Godat A et al on behalf of the EoE eosinophil distribution research group. Eosinophil distribution in eosinophilic esophagitis and its impact on disease activity and response to treatment. Clin Gastroenterol Hepatol. 2023 (Dec 15). doi: 10.1016/j.cgh.2023.12.003

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Eosinophil-derived neurotoxin can help diagnose eosinophilic esophagitis in exclusive distal eosinophilia

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Key clinical point: The levels of eosinophil-derived neurotoxin (EDN) may be used to track disease activity in patients with eosinophilic esophagitis (EoE) patients and may aid the diagnosis of EoE in patients with challenging conditions, such as distal eosinophilia.

Major finding: The average endoscopic reference score (EREFS; 3.4 vs 0.4; P < .001) and EDN concentrations (135.8 µg/mL vs 3.2 µg/mL; P < .001) were significantly higher in patients with active EoE vs control individuals. In patients with exclusive distant eosinophilia, positive (≥10 µg/mL) vs negative EDN concentrations correlated with significantly higher EREFS (3.33 vs 1.35, P < .001), which indicated a diagnosis of EoE.

Study details: Findings are from a retrospective study that included children and young adults who underwent routine endoscopy with biopsy and EDN esophageal epithelial brushings, of whom 140 had EoE and 91 were control individuals without EoE.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Thomas J et al. Addressing diagnostic dilemmas in eosinophilic esophagitis using esophageal epithelial eosinophil-derived neurotoxin. J Pediatr Gastroenterol Nutr. 2023 (Dec 27). doi: 10.1002/jpn3.12054

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Key clinical point: The levels of eosinophil-derived neurotoxin (EDN) may be used to track disease activity in patients with eosinophilic esophagitis (EoE) patients and may aid the diagnosis of EoE in patients with challenging conditions, such as distal eosinophilia.

Major finding: The average endoscopic reference score (EREFS; 3.4 vs 0.4; P < .001) and EDN concentrations (135.8 µg/mL vs 3.2 µg/mL; P < .001) were significantly higher in patients with active EoE vs control individuals. In patients with exclusive distant eosinophilia, positive (≥10 µg/mL) vs negative EDN concentrations correlated with significantly higher EREFS (3.33 vs 1.35, P < .001), which indicated a diagnosis of EoE.

Study details: Findings are from a retrospective study that included children and young adults who underwent routine endoscopy with biopsy and EDN esophageal epithelial brushings, of whom 140 had EoE and 91 were control individuals without EoE.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Thomas J et al. Addressing diagnostic dilemmas in eosinophilic esophagitis using esophageal epithelial eosinophil-derived neurotoxin. J Pediatr Gastroenterol Nutr. 2023 (Dec 27). doi: 10.1002/jpn3.12054

Key clinical point: The levels of eosinophil-derived neurotoxin (EDN) may be used to track disease activity in patients with eosinophilic esophagitis (EoE) patients and may aid the diagnosis of EoE in patients with challenging conditions, such as distal eosinophilia.

Major finding: The average endoscopic reference score (EREFS; 3.4 vs 0.4; P < .001) and EDN concentrations (135.8 µg/mL vs 3.2 µg/mL; P < .001) were significantly higher in patients with active EoE vs control individuals. In patients with exclusive distant eosinophilia, positive (≥10 µg/mL) vs negative EDN concentrations correlated with significantly higher EREFS (3.33 vs 1.35, P < .001), which indicated a diagnosis of EoE.

Study details: Findings are from a retrospective study that included children and young adults who underwent routine endoscopy with biopsy and EDN esophageal epithelial brushings, of whom 140 had EoE and 91 were control individuals without EoE.

Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.

Source: Thomas J et al. Addressing diagnostic dilemmas in eosinophilic esophagitis using esophageal epithelial eosinophil-derived neurotoxin. J Pediatr Gastroenterol Nutr. 2023 (Dec 27). doi: 10.1002/jpn3.12054

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Eosinophil levels may predict concomitant non-EoE diseases in patients with EoE

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Key clinical point: Patients with eosinophilic esophagitis (EoE) may also present with non-EoE eosinophilic gastrointestinal diseases (EGID) with esophageal involvement (EI; EGID + EI) if they have high levels of peripheral blood eosinophils.

Major finding: Patients with EGID + EI vs EoE were more likely to have eczema (P = .003), food allergy (P < .001), abdominal pain (60.9% vs 45.0%; P = .002), and higher peripheral blood eosinophil levels (0.44 × 103/µL vs 0.38 × 103/µL; P = .027).

Study details: Findings are from an observational cohort study including 592 patients with isolated EoE and 190 patients with EGID + EI.

Disclosures: This study was supported by a grant from the US National Institutes of Health. ME Rothenberg and corresponding author T Shoda declared serving as a consultant or being inventors or co-inventors of patents.

Source: Sato H et al. Eosinophil involvement outside the esophagus in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Dec 14). doi: 10.1016/j.cgh.2023.12.004

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Key clinical point: Patients with eosinophilic esophagitis (EoE) may also present with non-EoE eosinophilic gastrointestinal diseases (EGID) with esophageal involvement (EI; EGID + EI) if they have high levels of peripheral blood eosinophils.

Major finding: Patients with EGID + EI vs EoE were more likely to have eczema (P = .003), food allergy (P < .001), abdominal pain (60.9% vs 45.0%; P = .002), and higher peripheral blood eosinophil levels (0.44 × 103/µL vs 0.38 × 103/µL; P = .027).

Study details: Findings are from an observational cohort study including 592 patients with isolated EoE and 190 patients with EGID + EI.

Disclosures: This study was supported by a grant from the US National Institutes of Health. ME Rothenberg and corresponding author T Shoda declared serving as a consultant or being inventors or co-inventors of patents.

Source: Sato H et al. Eosinophil involvement outside the esophagus in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Dec 14). doi: 10.1016/j.cgh.2023.12.004

Key clinical point: Patients with eosinophilic esophagitis (EoE) may also present with non-EoE eosinophilic gastrointestinal diseases (EGID) with esophageal involvement (EI; EGID + EI) if they have high levels of peripheral blood eosinophils.

Major finding: Patients with EGID + EI vs EoE were more likely to have eczema (P = .003), food allergy (P < .001), abdominal pain (60.9% vs 45.0%; P = .002), and higher peripheral blood eosinophil levels (0.44 × 103/µL vs 0.38 × 103/µL; P = .027).

Study details: Findings are from an observational cohort study including 592 patients with isolated EoE and 190 patients with EGID + EI.

Disclosures: This study was supported by a grant from the US National Institutes of Health. ME Rothenberg and corresponding author T Shoda declared serving as a consultant or being inventors or co-inventors of patents.

Source: Sato H et al. Eosinophil involvement outside the esophagus in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Dec 14). doi: 10.1016/j.cgh.2023.12.004

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Real-world comparison of treatment pattern of CGRP antibodies in migraine

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Key clinical point: Patients with migraine initiating calcitonin gene-related peptide (CGRP) monoclonal antibody treatment with galcanezumab showed higher treatment persistence, lower treatment discontinuation, and similar adherence compared with those initiating fremanezumab or erenumab.

Major finding: Compared with fremanezumab, galcanezumab initiators showed higher rates of treatment persistence (P = .001) and lower treatment discontinuation (P = .005). Compared with erenumab, galcanezumab initiators had lower treatment discontinuation (P = .040). Patient adherence was similar among those who initiated galcanezumab vs fremanezumab or erenumab.

 

Study details: This retrospective real-world study included patients with migraine initiating galcanezumab treatment who were matched with those initiating fremanezumab (n = 2674) or erenumab (n = 3503) treatment using propensity score matching.

Disclosures: This study was funded by Eli Lilly and Company. The authors declared no conflicts of interest.

Source: Varnado OJ et al. Comparison of treatment patterns in patients with migraine initiating calcitonin gene-related peptide monoclonal antibodies: A Retrospective Real-World US Study. Patient Preference and Adherence. 2024;18:69-88 (Jan 9). doi: 10.2147/PPA.S437396

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Key clinical point: Patients with migraine initiating calcitonin gene-related peptide (CGRP) monoclonal antibody treatment with galcanezumab showed higher treatment persistence, lower treatment discontinuation, and similar adherence compared with those initiating fremanezumab or erenumab.

Major finding: Compared with fremanezumab, galcanezumab initiators showed higher rates of treatment persistence (P = .001) and lower treatment discontinuation (P = .005). Compared with erenumab, galcanezumab initiators had lower treatment discontinuation (P = .040). Patient adherence was similar among those who initiated galcanezumab vs fremanezumab or erenumab.

 

Study details: This retrospective real-world study included patients with migraine initiating galcanezumab treatment who were matched with those initiating fremanezumab (n = 2674) or erenumab (n = 3503) treatment using propensity score matching.

Disclosures: This study was funded by Eli Lilly and Company. The authors declared no conflicts of interest.

Source: Varnado OJ et al. Comparison of treatment patterns in patients with migraine initiating calcitonin gene-related peptide monoclonal antibodies: A Retrospective Real-World US Study. Patient Preference and Adherence. 2024;18:69-88 (Jan 9). doi: 10.2147/PPA.S437396

Key clinical point: Patients with migraine initiating calcitonin gene-related peptide (CGRP) monoclonal antibody treatment with galcanezumab showed higher treatment persistence, lower treatment discontinuation, and similar adherence compared with those initiating fremanezumab or erenumab.

Major finding: Compared with fremanezumab, galcanezumab initiators showed higher rates of treatment persistence (P = .001) and lower treatment discontinuation (P = .005). Compared with erenumab, galcanezumab initiators had lower treatment discontinuation (P = .040). Patient adherence was similar among those who initiated galcanezumab vs fremanezumab or erenumab.

 

Study details: This retrospective real-world study included patients with migraine initiating galcanezumab treatment who were matched with those initiating fremanezumab (n = 2674) or erenumab (n = 3503) treatment using propensity score matching.

Disclosures: This study was funded by Eli Lilly and Company. The authors declared no conflicts of interest.

Source: Varnado OJ et al. Comparison of treatment patterns in patients with migraine initiating calcitonin gene-related peptide monoclonal antibodies: A Retrospective Real-World US Study. Patient Preference and Adherence. 2024;18:69-88 (Jan 9). doi: 10.2147/PPA.S437396

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Higher delayed discounting rate among patients with episodic migraine without aura

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Key clinical point: Patients with episodic migraine without aura (EMoA) presented a higher delayed discounting rate, which was positively associated with the migraine history.

Major finding: Patients with EMoA vs control individuals showed a significantly higher subjective discount rate (F = 4.74; P = .032), which was positively correlated with migraine history (r = 0.742; P < .001). The resting-state functional connectivity between the left ventral striatum and middle occipital gyrus was significantly associated with migraine history (r′ = 0.294; P = .036) and subjective discount rate (r′ = 0.380; P = .006).

 

Study details: This study included 51 patients with EMoA and 45 control individuals who underwent task-based and multi-model magnetic resonance imaging.

Disclosures: This study was supported by the National Natural Science Foundation of China, Foundation for the Cultivation of Doctoral Research Talents, and the 2021 Youth Foundation Training Program of the First Affiliated Hospital of Anhui Medical University. The authors declared no conflicts of interest.

Source: Wang L et al. Patients with episodic migraine without aura have an increased rate of delayed discounting. Brain Behav. 2024;14(1):e3367 (Jan 2). doi: 10.1002/brb3.3367

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Key clinical point: Patients with episodic migraine without aura (EMoA) presented a higher delayed discounting rate, which was positively associated with the migraine history.

Major finding: Patients with EMoA vs control individuals showed a significantly higher subjective discount rate (F = 4.74; P = .032), which was positively correlated with migraine history (r = 0.742; P < .001). The resting-state functional connectivity between the left ventral striatum and middle occipital gyrus was significantly associated with migraine history (r′ = 0.294; P = .036) and subjective discount rate (r′ = 0.380; P = .006).

 

Study details: This study included 51 patients with EMoA and 45 control individuals who underwent task-based and multi-model magnetic resonance imaging.

Disclosures: This study was supported by the National Natural Science Foundation of China, Foundation for the Cultivation of Doctoral Research Talents, and the 2021 Youth Foundation Training Program of the First Affiliated Hospital of Anhui Medical University. The authors declared no conflicts of interest.

Source: Wang L et al. Patients with episodic migraine without aura have an increased rate of delayed discounting. Brain Behav. 2024;14(1):e3367 (Jan 2). doi: 10.1002/brb3.3367

Key clinical point: Patients with episodic migraine without aura (EMoA) presented a higher delayed discounting rate, which was positively associated with the migraine history.

Major finding: Patients with EMoA vs control individuals showed a significantly higher subjective discount rate (F = 4.74; P = .032), which was positively correlated with migraine history (r = 0.742; P < .001). The resting-state functional connectivity between the left ventral striatum and middle occipital gyrus was significantly associated with migraine history (r′ = 0.294; P = .036) and subjective discount rate (r′ = 0.380; P = .006).

 

Study details: This study included 51 patients with EMoA and 45 control individuals who underwent task-based and multi-model magnetic resonance imaging.

Disclosures: This study was supported by the National Natural Science Foundation of China, Foundation for the Cultivation of Doctoral Research Talents, and the 2021 Youth Foundation Training Program of the First Affiliated Hospital of Anhui Medical University. The authors declared no conflicts of interest.

Source: Wang L et al. Patients with episodic migraine without aura have an increased rate of delayed discounting. Brain Behav. 2024;14(1):e3367 (Jan 2). doi: 10.1002/brb3.3367

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