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Atopic Dermatitis in Early Life Might Increase Pain in Children at Age 10 Years

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Key clinical point: The presence of atopic dermatitis (AD) symptoms in children during early life is associated with increased likelihood of pain at 10 years of age, suggesting a prospective influence of AD on pain experiences in children.

Major finding: Children with AD-like symptoms at 6 and 15 months of age had a significantly higher risk of reporting any pain (relative risk [RR] 1.75; 95% CI 1.15-2.66) and multisite pain (RR 1.67; 95% CI 1.18-2.37), respectively, at age 10 years.

Study details: This prospective study analyzed the data of 1302 and 874 children from the Generation XXI birth cohort for AD-like symptoms at ages 6 months and 15 months, respectively, by interviewing parents; data on pain history in the last 3 months at age 10 years was collected using structured questionnaires for parents and children.

Disclosures: This study was funded by the European Regional Development Fund, through COMPETE 2020 Operational Programme 'Competitiveness and Internationalization,' projects at the Univeridade do Porto, Portugal, and others. The authors declared no conflicts of interest.

Source: Gorito V, Brandão M, Azevedo I, et al. Atopic dermatitis in early life and pain at 10 years of age: An exploratory study. Eur J Pediatr. 2024 (Feb 24). doi: 10.1007/s00431-024-05439-0 Source

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Key clinical point: The presence of atopic dermatitis (AD) symptoms in children during early life is associated with increased likelihood of pain at 10 years of age, suggesting a prospective influence of AD on pain experiences in children.

Major finding: Children with AD-like symptoms at 6 and 15 months of age had a significantly higher risk of reporting any pain (relative risk [RR] 1.75; 95% CI 1.15-2.66) and multisite pain (RR 1.67; 95% CI 1.18-2.37), respectively, at age 10 years.

Study details: This prospective study analyzed the data of 1302 and 874 children from the Generation XXI birth cohort for AD-like symptoms at ages 6 months and 15 months, respectively, by interviewing parents; data on pain history in the last 3 months at age 10 years was collected using structured questionnaires for parents and children.

Disclosures: This study was funded by the European Regional Development Fund, through COMPETE 2020 Operational Programme 'Competitiveness and Internationalization,' projects at the Univeridade do Porto, Portugal, and others. The authors declared no conflicts of interest.

Source: Gorito V, Brandão M, Azevedo I, et al. Atopic dermatitis in early life and pain at 10 years of age: An exploratory study. Eur J Pediatr. 2024 (Feb 24). doi: 10.1007/s00431-024-05439-0 Source

Key clinical point: The presence of atopic dermatitis (AD) symptoms in children during early life is associated with increased likelihood of pain at 10 years of age, suggesting a prospective influence of AD on pain experiences in children.

Major finding: Children with AD-like symptoms at 6 and 15 months of age had a significantly higher risk of reporting any pain (relative risk [RR] 1.75; 95% CI 1.15-2.66) and multisite pain (RR 1.67; 95% CI 1.18-2.37), respectively, at age 10 years.

Study details: This prospective study analyzed the data of 1302 and 874 children from the Generation XXI birth cohort for AD-like symptoms at ages 6 months and 15 months, respectively, by interviewing parents; data on pain history in the last 3 months at age 10 years was collected using structured questionnaires for parents and children.

Disclosures: This study was funded by the European Regional Development Fund, through COMPETE 2020 Operational Programme 'Competitiveness and Internationalization,' projects at the Univeridade do Porto, Portugal, and others. The authors declared no conflicts of interest.

Source: Gorito V, Brandão M, Azevedo I, et al. Atopic dermatitis in early life and pain at 10 years of age: An exploratory study. Eur J Pediatr. 2024 (Feb 24). doi: 10.1007/s00431-024-05439-0 Source

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Topical Streptococcus Postbiotic Emollient Safe and Effective in Atopic Dermatitis

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Key clinical point: Topical Streptococcus postbiotic emollient (strain CX) demonstrated superior efficacy in improving disease activity outcomes and a tolerable safety profile in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 8, a higher percentage of patients in the topical Streptococcus postbiotic emollient vs placebo group (41.5% vs 12.1%; P = .005) achieved an Investigator’s Global Assessment score of 0 or 1 and a reduction of ≥1 point from baseline. No significant safety issues were identified during the study.

Study details: Findings are from a proof-of-concept trial including 98 patients with mild-to-moderate AD (age 12-70 years) who were randomly assigned 2:1 to receive daily topical 1.0% Strain CX postbiotic emollient (n = 65) or placebo (n = 33) for 8 weeks.

Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and Cosmax BTI. The authors declared no conflicts of interest.

Source: Kim MS, Kim HJ, Kang SM, Heo YM, Kang J, et al. Efficacy and safety of topical Streptococcus postbiotic emollient in adolescents and adults with mild-to-moderate atopic dermatitis: A randomized, double-blind, vehicle-controlled trial. Allergy. 2024 (Mar 4). doi: 10.1111/all.16077 Source

 

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Key clinical point: Topical Streptococcus postbiotic emollient (strain CX) demonstrated superior efficacy in improving disease activity outcomes and a tolerable safety profile in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 8, a higher percentage of patients in the topical Streptococcus postbiotic emollient vs placebo group (41.5% vs 12.1%; P = .005) achieved an Investigator’s Global Assessment score of 0 or 1 and a reduction of ≥1 point from baseline. No significant safety issues were identified during the study.

Study details: Findings are from a proof-of-concept trial including 98 patients with mild-to-moderate AD (age 12-70 years) who were randomly assigned 2:1 to receive daily topical 1.0% Strain CX postbiotic emollient (n = 65) or placebo (n = 33) for 8 weeks.

Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and Cosmax BTI. The authors declared no conflicts of interest.

Source: Kim MS, Kim HJ, Kang SM, Heo YM, Kang J, et al. Efficacy and safety of topical Streptococcus postbiotic emollient in adolescents and adults with mild-to-moderate atopic dermatitis: A randomized, double-blind, vehicle-controlled trial. Allergy. 2024 (Mar 4). doi: 10.1111/all.16077 Source

 

Key clinical point: Topical Streptococcus postbiotic emollient (strain CX) demonstrated superior efficacy in improving disease activity outcomes and a tolerable safety profile in patients with mild-to-moderate atopic dermatitis (AD).

Major finding: At week 8, a higher percentage of patients in the topical Streptococcus postbiotic emollient vs placebo group (41.5% vs 12.1%; P = .005) achieved an Investigator’s Global Assessment score of 0 or 1 and a reduction of ≥1 point from baseline. No significant safety issues were identified during the study.

Study details: Findings are from a proof-of-concept trial including 98 patients with mild-to-moderate AD (age 12-70 years) who were randomly assigned 2:1 to receive daily topical 1.0% Strain CX postbiotic emollient (n = 65) or placebo (n = 33) for 8 weeks.

Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government and Cosmax BTI. The authors declared no conflicts of interest.

Source: Kim MS, Kim HJ, Kang SM, Heo YM, Kang J, et al. Efficacy and safety of topical Streptococcus postbiotic emollient in adolescents and adults with mild-to-moderate atopic dermatitis: A randomized, double-blind, vehicle-controlled trial. Allergy. 2024 (Mar 4). doi: 10.1111/all.16077 Source

 

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Atopic Dermatitis Associated With Cognitive Impairment Symptoms in Children

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Key clinical point: Atopic dermatitis (AD) is associated with a higher likelihood of cognitive impairment symptoms involving difficulties in learning or memory, especially in children with neurodevelopmental comorbidities, such as attention-deficit/hyperactivity disorder (ADHD) or learning disability.

Major finding: A significantly greater number of children with vs without AD experienced difficulties with learning (10.8% vs 5.9%) and memory (11.1% vs 5.8%; both P < .001). However, this association was observed only in children with neurodevelopmental disorders (adjusted odds ratio 2.26; 95% CI 1.43-3.57) including ADHD or learning disabilities.

Study details: This cross-sectional study analyzed the data of 7957 children, representing a weighted total of 69,732,807 children without intellectual disabilities from the 2021 US National Health Interview Survey who did (n = 9,223,013) or did not (n = 60,509,794) have AD. The survey randomly selects 1 child per surveyed household for whom a parent or adult caregiver provides information.

Disclosures: This study was supported by a grant to Joy Wan from the US National Institutes of Health. Joy Wan also declared receiving a grant and personal fees from various pharmaceutical companies. The other authors declared no conflicts of interest.

Source: Ma EZ, Chang HR, Radtke S, Wan J. Symptoms of cognitive impairment among children with atopic dermatitis. JAMA Dermatol. 2024 (Mar 6). doi: 10.1001/jamadermatol.2024.0015 Source

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Key clinical point: Atopic dermatitis (AD) is associated with a higher likelihood of cognitive impairment symptoms involving difficulties in learning or memory, especially in children with neurodevelopmental comorbidities, such as attention-deficit/hyperactivity disorder (ADHD) or learning disability.

Major finding: A significantly greater number of children with vs without AD experienced difficulties with learning (10.8% vs 5.9%) and memory (11.1% vs 5.8%; both P < .001). However, this association was observed only in children with neurodevelopmental disorders (adjusted odds ratio 2.26; 95% CI 1.43-3.57) including ADHD or learning disabilities.

Study details: This cross-sectional study analyzed the data of 7957 children, representing a weighted total of 69,732,807 children without intellectual disabilities from the 2021 US National Health Interview Survey who did (n = 9,223,013) or did not (n = 60,509,794) have AD. The survey randomly selects 1 child per surveyed household for whom a parent or adult caregiver provides information.

Disclosures: This study was supported by a grant to Joy Wan from the US National Institutes of Health. Joy Wan also declared receiving a grant and personal fees from various pharmaceutical companies. The other authors declared no conflicts of interest.

Source: Ma EZ, Chang HR, Radtke S, Wan J. Symptoms of cognitive impairment among children with atopic dermatitis. JAMA Dermatol. 2024 (Mar 6). doi: 10.1001/jamadermatol.2024.0015 Source

Key clinical point: Atopic dermatitis (AD) is associated with a higher likelihood of cognitive impairment symptoms involving difficulties in learning or memory, especially in children with neurodevelopmental comorbidities, such as attention-deficit/hyperactivity disorder (ADHD) or learning disability.

Major finding: A significantly greater number of children with vs without AD experienced difficulties with learning (10.8% vs 5.9%) and memory (11.1% vs 5.8%; both P < .001). However, this association was observed only in children with neurodevelopmental disorders (adjusted odds ratio 2.26; 95% CI 1.43-3.57) including ADHD or learning disabilities.

Study details: This cross-sectional study analyzed the data of 7957 children, representing a weighted total of 69,732,807 children without intellectual disabilities from the 2021 US National Health Interview Survey who did (n = 9,223,013) or did not (n = 60,509,794) have AD. The survey randomly selects 1 child per surveyed household for whom a parent or adult caregiver provides information.

Disclosures: This study was supported by a grant to Joy Wan from the US National Institutes of Health. Joy Wan also declared receiving a grant and personal fees from various pharmaceutical companies. The other authors declared no conflicts of interest.

Source: Ma EZ, Chang HR, Radtke S, Wan J. Symptoms of cognitive impairment among children with atopic dermatitis. JAMA Dermatol. 2024 (Mar 6). doi: 10.1001/jamadermatol.2024.0015 Source

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Sublingual Immunotherapy Safe, Effective for Older Kids

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Thu, 03/14/2024 - 07:39

Sublingual immunotherapy (SLIT) is as safe and effective for high-risk older children and adolescents as oral immunotherapy (OIT) is for infants and preschoolers, according to new research.

Preliminary data from a study of more than 180 pediatric patients with multiple food allergies showed that while most patients had mild symptoms, none experienced a severe grade 4 reaction during the buildup and maintenance phase of SLIT.

In addition, 70% of those tested at the end of the treatment protocol were able to tolerate 300 mg of their allergen, a success rate nearly as high as that for OIT.

The study was published in The Journal of Allergy and Clinical Immunology: In Practice.

SLIT has been used successfully in the treatment of environmental allergens such as grass and tree pollen and dust mites. In this study, researchers decided to test SLIT’s effectiveness and safety in the treatment of food allergies in older children.

“We knew that OIT is very effective and safe in infants and toddlers, but there was literature illustrating that for older, school-age kids and adolescents, OIT is not safe enough, as those older age groups tend to have higher risk of severe reaction during treatment,” senior author Edmond Chan, MD, clinical professor of allergy at the University of British Columbia and pediatric allergist at BC Children’s Hospital, both in Vancouver, British Columbia, Canada, told this news organization. “With that knowledge, we decided to explore SLIT as another first-phase therapy for the older kids.”

The investigators recruited 188 high-risk older children aged 4-18 years for multifood SLIT. Most (61.7%) participants had multiple food allergies. Approximately 68% were male, and the population’s median age was 11.3 years.

Nearly half (48.4%) of participants had atopic dermatitis, 45.2% had asthma, 58.0% had allergic rhinitis, and 2.66% had preexisting eosinophilic esophagitis.

Most (75.0%) of the children were classified as higher risk, and 23 had a history of a grade 3 or 4 reaction before beginning SLIT.

Of the 188 children who were initially enrolled in the study, 173 (92.0%) finished their SLIT buildup phase.

Because the study started when COVID-19 pandemic restrictions were in place, the SLIT protocol mandated that patients be seen virtually. The patients’ caregivers learned how to mix and administer the required doses at home using recipes specially developed by the research team that used products bought at the grocery store.

A wide variety of food allergens were treated, including peanut, other legumes, tree nuts, sesame, other seeds, egg, cow’s milk, fish, wheat, shrimp, and other allergens.

The children built up to 2-mg protein SLIT maintenance over the course of three to five visits under nurse supervision.

After 1-2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC; cumulative dose: 300 mg of protein) with the goal of bypassing OIT buildup.

Nearly all patients (93.1%) had symptoms during SLIT buildup, but most were mild grade 1 (52.1%) or 2 (40.4%) reactions. Only one patient had a grade 3 reaction. None of the patients experienced a severe grade 4 reaction.

The most common grade 1 reaction was oral itch, an expected symptom of SLIT, which occurred in 82.7% of the patients.

Four patients (2.10%) received epinephrine during buildup and went to the emergency department. All these patients returned to continue SLIT without further need for epinephrine.

To test the effectiveness of SLIT, the researchers performed 50 low-dose OFCs in 20 patients. Of these food challenges, 35 (70%) were successful, and patients were asked to start daily 300-mg OIT maintenance, thus bypassing OIT buildup.

An additional nine OFCs that were unsuccessful were counseled to self-escalate from 80 mg or higher to 300 mg at home with medical guidance as needed.

“Our preliminary data of 20 patients and 50 low-dose oral food challenges suggest that an initial phase of 1-2 years of 2-mg daily SLIT therapy may be a safe and effective way to bypass the OIT buildup phase without the need for dozens of in-person visits with an allergist,” said Dr. Chan.

“So now we have the best of both worlds. We harness the safety of SLIT for the first 1-2 years, with the effectiveness of OIT for the remainder of the treatment period,” he said.
 

 

 

Adds to Evidence

Commenting on the study for this news organization, Julia Upton, MD, associate professor of pediatrics at the University of Toronto, Toronto, Ontario, Canada, said, “This study adds to the evidence that consistent, low exposure to food drives meaningful desensitization far above the daily dose.” Upton did not participate in the research.

“Prior prospective studies in SLIT demonstrated that small single-digit-milligram doses and time greatly increased the threshold of reaction. This real-world report suggests that a way to utilize that threshold increase is by switching to a commonly used maintenance dose of OIT,” said Dr. Upton.

“Although few patients have been assessed for the 300-mg challenge, this study is notable for the age group of 4-18 years, and that many of the patients had reacted to low doses in the past. It also shows that many families are capable of diluting and mixing their own immunotherapy solutions with store-bought foods under the guidance of an experienced allergy clinic,” she added.

“Overall, evidence is building that by various routes, initial small amounts with minimal updoses, plus the tincture of time, may be preferred to multiple frequent updosing from multiple perspectives, including safety, feasibility, cost, and medical resources. It will also be important to understand the preferences and goals of the patient and family as various regimens become more available,” Dr. Upton concluded.

The study was funded by BC Children’s Hospital Foundation. Dr. Chan reported receiving research support from DVB Technologies; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi, Genzyme, Bausch Health, Avir Pharma, AstraZeneca, ALK, and Alladapt; and was a colead of the CSACI OIT guidelines. Dr. Upton reported research support/grants from Novartis, Regeneron, Sanofi, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program and fees from Pfizer, ALK Abello, Bausch Health, Astra Zeneca, and Pharming. She serves as an associate editor for Allergy, Asthma & Clinical Immunology and is on the Board of Directors of Canadian Society of Allergy and Clinical Immunology and the Healthcare Advisory Board of Food Allergy Canada.

A version of this article appeared on Medscape.com .

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Sublingual immunotherapy (SLIT) is as safe and effective for high-risk older children and adolescents as oral immunotherapy (OIT) is for infants and preschoolers, according to new research.

Preliminary data from a study of more than 180 pediatric patients with multiple food allergies showed that while most patients had mild symptoms, none experienced a severe grade 4 reaction during the buildup and maintenance phase of SLIT.

In addition, 70% of those tested at the end of the treatment protocol were able to tolerate 300 mg of their allergen, a success rate nearly as high as that for OIT.

The study was published in The Journal of Allergy and Clinical Immunology: In Practice.

SLIT has been used successfully in the treatment of environmental allergens such as grass and tree pollen and dust mites. In this study, researchers decided to test SLIT’s effectiveness and safety in the treatment of food allergies in older children.

“We knew that OIT is very effective and safe in infants and toddlers, but there was literature illustrating that for older, school-age kids and adolescents, OIT is not safe enough, as those older age groups tend to have higher risk of severe reaction during treatment,” senior author Edmond Chan, MD, clinical professor of allergy at the University of British Columbia and pediatric allergist at BC Children’s Hospital, both in Vancouver, British Columbia, Canada, told this news organization. “With that knowledge, we decided to explore SLIT as another first-phase therapy for the older kids.”

The investigators recruited 188 high-risk older children aged 4-18 years for multifood SLIT. Most (61.7%) participants had multiple food allergies. Approximately 68% were male, and the population’s median age was 11.3 years.

Nearly half (48.4%) of participants had atopic dermatitis, 45.2% had asthma, 58.0% had allergic rhinitis, and 2.66% had preexisting eosinophilic esophagitis.

Most (75.0%) of the children were classified as higher risk, and 23 had a history of a grade 3 or 4 reaction before beginning SLIT.

Of the 188 children who were initially enrolled in the study, 173 (92.0%) finished their SLIT buildup phase.

Because the study started when COVID-19 pandemic restrictions were in place, the SLIT protocol mandated that patients be seen virtually. The patients’ caregivers learned how to mix and administer the required doses at home using recipes specially developed by the research team that used products bought at the grocery store.

A wide variety of food allergens were treated, including peanut, other legumes, tree nuts, sesame, other seeds, egg, cow’s milk, fish, wheat, shrimp, and other allergens.

The children built up to 2-mg protein SLIT maintenance over the course of three to five visits under nurse supervision.

After 1-2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC; cumulative dose: 300 mg of protein) with the goal of bypassing OIT buildup.

Nearly all patients (93.1%) had symptoms during SLIT buildup, but most were mild grade 1 (52.1%) or 2 (40.4%) reactions. Only one patient had a grade 3 reaction. None of the patients experienced a severe grade 4 reaction.

The most common grade 1 reaction was oral itch, an expected symptom of SLIT, which occurred in 82.7% of the patients.

Four patients (2.10%) received epinephrine during buildup and went to the emergency department. All these patients returned to continue SLIT without further need for epinephrine.

To test the effectiveness of SLIT, the researchers performed 50 low-dose OFCs in 20 patients. Of these food challenges, 35 (70%) were successful, and patients were asked to start daily 300-mg OIT maintenance, thus bypassing OIT buildup.

An additional nine OFCs that were unsuccessful were counseled to self-escalate from 80 mg or higher to 300 mg at home with medical guidance as needed.

“Our preliminary data of 20 patients and 50 low-dose oral food challenges suggest that an initial phase of 1-2 years of 2-mg daily SLIT therapy may be a safe and effective way to bypass the OIT buildup phase without the need for dozens of in-person visits with an allergist,” said Dr. Chan.

“So now we have the best of both worlds. We harness the safety of SLIT for the first 1-2 years, with the effectiveness of OIT for the remainder of the treatment period,” he said.
 

 

 

Adds to Evidence

Commenting on the study for this news organization, Julia Upton, MD, associate professor of pediatrics at the University of Toronto, Toronto, Ontario, Canada, said, “This study adds to the evidence that consistent, low exposure to food drives meaningful desensitization far above the daily dose.” Upton did not participate in the research.

“Prior prospective studies in SLIT demonstrated that small single-digit-milligram doses and time greatly increased the threshold of reaction. This real-world report suggests that a way to utilize that threshold increase is by switching to a commonly used maintenance dose of OIT,” said Dr. Upton.

“Although few patients have been assessed for the 300-mg challenge, this study is notable for the age group of 4-18 years, and that many of the patients had reacted to low doses in the past. It also shows that many families are capable of diluting and mixing their own immunotherapy solutions with store-bought foods under the guidance of an experienced allergy clinic,” she added.

“Overall, evidence is building that by various routes, initial small amounts with minimal updoses, plus the tincture of time, may be preferred to multiple frequent updosing from multiple perspectives, including safety, feasibility, cost, and medical resources. It will also be important to understand the preferences and goals of the patient and family as various regimens become more available,” Dr. Upton concluded.

The study was funded by BC Children’s Hospital Foundation. Dr. Chan reported receiving research support from DVB Technologies; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi, Genzyme, Bausch Health, Avir Pharma, AstraZeneca, ALK, and Alladapt; and was a colead of the CSACI OIT guidelines. Dr. Upton reported research support/grants from Novartis, Regeneron, Sanofi, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program and fees from Pfizer, ALK Abello, Bausch Health, Astra Zeneca, and Pharming. She serves as an associate editor for Allergy, Asthma & Clinical Immunology and is on the Board of Directors of Canadian Society of Allergy and Clinical Immunology and the Healthcare Advisory Board of Food Allergy Canada.

A version of this article appeared on Medscape.com .

Sublingual immunotherapy (SLIT) is as safe and effective for high-risk older children and adolescents as oral immunotherapy (OIT) is for infants and preschoolers, according to new research.

Preliminary data from a study of more than 180 pediatric patients with multiple food allergies showed that while most patients had mild symptoms, none experienced a severe grade 4 reaction during the buildup and maintenance phase of SLIT.

In addition, 70% of those tested at the end of the treatment protocol were able to tolerate 300 mg of their allergen, a success rate nearly as high as that for OIT.

The study was published in The Journal of Allergy and Clinical Immunology: In Practice.

SLIT has been used successfully in the treatment of environmental allergens such as grass and tree pollen and dust mites. In this study, researchers decided to test SLIT’s effectiveness and safety in the treatment of food allergies in older children.

“We knew that OIT is very effective and safe in infants and toddlers, but there was literature illustrating that for older, school-age kids and adolescents, OIT is not safe enough, as those older age groups tend to have higher risk of severe reaction during treatment,” senior author Edmond Chan, MD, clinical professor of allergy at the University of British Columbia and pediatric allergist at BC Children’s Hospital, both in Vancouver, British Columbia, Canada, told this news organization. “With that knowledge, we decided to explore SLIT as another first-phase therapy for the older kids.”

The investigators recruited 188 high-risk older children aged 4-18 years for multifood SLIT. Most (61.7%) participants had multiple food allergies. Approximately 68% were male, and the population’s median age was 11.3 years.

Nearly half (48.4%) of participants had atopic dermatitis, 45.2% had asthma, 58.0% had allergic rhinitis, and 2.66% had preexisting eosinophilic esophagitis.

Most (75.0%) of the children were classified as higher risk, and 23 had a history of a grade 3 or 4 reaction before beginning SLIT.

Of the 188 children who were initially enrolled in the study, 173 (92.0%) finished their SLIT buildup phase.

Because the study started when COVID-19 pandemic restrictions were in place, the SLIT protocol mandated that patients be seen virtually. The patients’ caregivers learned how to mix and administer the required doses at home using recipes specially developed by the research team that used products bought at the grocery store.

A wide variety of food allergens were treated, including peanut, other legumes, tree nuts, sesame, other seeds, egg, cow’s milk, fish, wheat, shrimp, and other allergens.

The children built up to 2-mg protein SLIT maintenance over the course of three to five visits under nurse supervision.

After 1-2 years of daily SLIT maintenance, patients were offered a low-dose oral food challenge (OFC; cumulative dose: 300 mg of protein) with the goal of bypassing OIT buildup.

Nearly all patients (93.1%) had symptoms during SLIT buildup, but most were mild grade 1 (52.1%) or 2 (40.4%) reactions. Only one patient had a grade 3 reaction. None of the patients experienced a severe grade 4 reaction.

The most common grade 1 reaction was oral itch, an expected symptom of SLIT, which occurred in 82.7% of the patients.

Four patients (2.10%) received epinephrine during buildup and went to the emergency department. All these patients returned to continue SLIT without further need for epinephrine.

To test the effectiveness of SLIT, the researchers performed 50 low-dose OFCs in 20 patients. Of these food challenges, 35 (70%) were successful, and patients were asked to start daily 300-mg OIT maintenance, thus bypassing OIT buildup.

An additional nine OFCs that were unsuccessful were counseled to self-escalate from 80 mg or higher to 300 mg at home with medical guidance as needed.

“Our preliminary data of 20 patients and 50 low-dose oral food challenges suggest that an initial phase of 1-2 years of 2-mg daily SLIT therapy may be a safe and effective way to bypass the OIT buildup phase without the need for dozens of in-person visits with an allergist,” said Dr. Chan.

“So now we have the best of both worlds. We harness the safety of SLIT for the first 1-2 years, with the effectiveness of OIT for the remainder of the treatment period,” he said.
 

 

 

Adds to Evidence

Commenting on the study for this news organization, Julia Upton, MD, associate professor of pediatrics at the University of Toronto, Toronto, Ontario, Canada, said, “This study adds to the evidence that consistent, low exposure to food drives meaningful desensitization far above the daily dose.” Upton did not participate in the research.

“Prior prospective studies in SLIT demonstrated that small single-digit-milligram doses and time greatly increased the threshold of reaction. This real-world report suggests that a way to utilize that threshold increase is by switching to a commonly used maintenance dose of OIT,” said Dr. Upton.

“Although few patients have been assessed for the 300-mg challenge, this study is notable for the age group of 4-18 years, and that many of the patients had reacted to low doses in the past. It also shows that many families are capable of diluting and mixing their own immunotherapy solutions with store-bought foods under the guidance of an experienced allergy clinic,” she added.

“Overall, evidence is building that by various routes, initial small amounts with minimal updoses, plus the tincture of time, may be preferred to multiple frequent updosing from multiple perspectives, including safety, feasibility, cost, and medical resources. It will also be important to understand the preferences and goals of the patient and family as various regimens become more available,” Dr. Upton concluded.

The study was funded by BC Children’s Hospital Foundation. Dr. Chan reported receiving research support from DVB Technologies; has been a member of advisory boards for Pfizer, Miravo, Medexus, Leo Pharma, Kaleo, DBV, AllerGenis, Sanofi, Genzyme, Bausch Health, Avir Pharma, AstraZeneca, ALK, and Alladapt; and was a colead of the CSACI OIT guidelines. Dr. Upton reported research support/grants from Novartis, Regeneron, Sanofi, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program and fees from Pfizer, ALK Abello, Bausch Health, Astra Zeneca, and Pharming. She serves as an associate editor for Allergy, Asthma & Clinical Immunology and is on the Board of Directors of Canadian Society of Allergy and Clinical Immunology and the Healthcare Advisory Board of Food Allergy Canada.

A version of this article appeared on Medscape.com .

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THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

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Is Atopic Dermatitis Linked to Cognitive Impairment Symptoms in Children?

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TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

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TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

 

TOPLINE:

The odds of having cognitive impairment may be increased among children with atopic dermatitis, primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder (ADHD) or a learning disability.

METHODOLOGY:

It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.

To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.

Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.

The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.

TAKEAWAY:

Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).

On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41). 

When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).

Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions. 

IN PRACTICE:

“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.

SOURCE:

Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep. 

DISCLOSURES:

The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report. 

A version of this article appeared on Medscape.com.

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Omalizumab for Food Allergies: What PCPs Should Know

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Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies

Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.

Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.

While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions. 

An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.

The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.

Patient Selection Key

While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.

“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”

Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.” 

Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.

“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.

Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.

“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”

Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.

For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.

“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said. 

 

 

Managing Potential Harms

Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said. 

Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said. 

Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”

The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.

Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.

Lifelong Treatment 

Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.

Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.

Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said. 

Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.

“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.

The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies

Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.

Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.

While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions. 

An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.

The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.

Patient Selection Key

While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.

“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”

Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.” 

Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.

“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.

Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.

“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”

Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.

For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.

“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said. 

 

 

Managing Potential Harms

Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said. 

Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said. 

Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”

The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.

Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.

Lifelong Treatment 

Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.

Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.

Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said. 

Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.

“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.

The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies

Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.

Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.

While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions. 

An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.

The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.

Patient Selection Key

While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.

“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”

Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.” 

Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.

“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.

Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.

“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”

Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.

For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.

“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said. 

 

 

Managing Potential Harms

Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said. 

Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said. 

Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”

The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.

Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.

Lifelong Treatment 

Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.

Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.

Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said. 

Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.

“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.

The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Climate Change and AD: New Review Shows Negative Impacts and Unknowns

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Thu, 02/29/2024 - 13:53

A new review of the literature on climate change and atopic dermatitis (AD) found evidence of a broad and negative impact of climatic hazards on various aspects of AD, including prevalence, severity/flares, and AD-related health care utilization. But it also showed the extent to which research is lacking.

“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.

Dr. Katrina Abuabara associate professor of dermatology and epidemiology, University of Californai, San Francisco.
Dr. Abuabara
Dr. Katrina Abuabara

“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”

Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology. 

Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.

“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.

Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”

Dr. Lawrence Eichenfield, professor of dermatology and pediatrics at the University of California San Diego, and Rady Children's Hospital, San Diego
Courtesy University of California, San Diego
Dr. Lawrence F. Eichenfield


Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
 

 

 

Mixed Results, But Negative Impacts Overall

The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.

Dead, polluted side/Green clear sky side
angkhan/Getty Images

The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.

Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.

In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.



Studies From 10 Countries Reviewed

Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.

Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.

“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”

In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”

The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
 

 

 

The Need to Better Track AD, Anticipate Clinical Impact

“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.

More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.

There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”

She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.



The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.

The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.

More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.

Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.

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A new review of the literature on climate change and atopic dermatitis (AD) found evidence of a broad and negative impact of climatic hazards on various aspects of AD, including prevalence, severity/flares, and AD-related health care utilization. But it also showed the extent to which research is lacking.

“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.

Dr. Katrina Abuabara associate professor of dermatology and epidemiology, University of Californai, San Francisco.
Dr. Abuabara
Dr. Katrina Abuabara

“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”

Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology. 

Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.

“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.

Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”

Dr. Lawrence Eichenfield, professor of dermatology and pediatrics at the University of California San Diego, and Rady Children's Hospital, San Diego
Courtesy University of California, San Diego
Dr. Lawrence F. Eichenfield


Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
 

 

 

Mixed Results, But Negative Impacts Overall

The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.

Dead, polluted side/Green clear sky side
angkhan/Getty Images

The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.

Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.

In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.



Studies From 10 Countries Reviewed

Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.

Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.

“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”

In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”

The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
 

 

 

The Need to Better Track AD, Anticipate Clinical Impact

“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.

More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.

There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”

She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.



The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.

The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.

More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.

Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.

A new review of the literature on climate change and atopic dermatitis (AD) found evidence of a broad and negative impact of climatic hazards on various aspects of AD, including prevalence, severity/flares, and AD-related health care utilization. But it also showed the extent to which research is lacking.

“There’s not as much out there as one might expect, given that this is the most common dermatologic disease and one of the most burdensome diseases worldwide,” said Katrina Abuabara, MD, of the department of dermatology at the University of California, San Francisco, one of the senior authors of the review.

Dr. Katrina Abuabara associate professor of dermatology and epidemiology, University of Californai, San Francisco.
Dr. Abuabara
Dr. Katrina Abuabara

“There’s a genetic predisposition to AD, but it’s certainly very environmentally patterned,” she said in an interview. “Given that we know there are strong environmental influences, it’s an obvious example of how climate change affects our health ... It is one that may be underappreciated and that could give us near-term information.”

Indeed, she and her coauthors emphasized in their paper, “AD could serve as a case study for climatic impacts on health.” The review, which looked beyond the realm of air pollution, was published in Allergy, the journal of the European Academy of Allergy and Clinical Immunology. 

Dr. Abuabara, UCSF dermatologist Sheng-Pei Wang, MD, MPH, and their coauthors — dermatologists and others from the United States, Europe, Brazil, and India — were convened by the International Eczema Council and teamed up with a biologist and climate science expert, Camilo Mora, PhD, of the University of Hawaii at Mānoa, Honolulu. Because research to date has focused on air pollution, with the impact of other hazards that Dr. Abuabara said were “a lot less developed and organized,” they used a framework and search strategy developed by Dr. Mora that looks at 10 climatic hazards related to greenhouse gas emissions, including heat waves, drought, precipitation, wildfires, and sea level rise.

“Given that this [framework] was already out there in the literature, we thought it would give us a structure and a nice way to organize the literature,” Dr. Abuabara said. While the literature is too heterogeneous for a systematic review and meta-analysis, the researchers used a systematic approach, she explained.

Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and a coauthor of the paper, said in an e-mail that the review raises “our consciousness about how these [climate] changes may be impacting atopic dermatitis.”

Dr. Lawrence Eichenfield, professor of dermatology and pediatrics at the University of California San Diego, and Rady Children's Hospital, San Diego
Courtesy University of California, San Diego
Dr. Lawrence F. Eichenfield


Researchers have “much work to do to understand the evolving impact on AD development and course, and even more to figure out how to avoid extreme weather’s impact to minimize its effects on inflammatory skin diseases,” he said. “In the meantime, this paper is a call for the health care community to recognize a set of factors that can influence our patients’ dermatitis and lives.”
 

 

 

Mixed Results, But Negative Impacts Overall

The researchers identified 18 studies across most of the 10 climatic hazards with evidence for an impact on AD, the majority of which demonstrated harmful effects on various aspects of AD — most commonly on AD-related health care utilization and severity/flares. Only three of the studies examined AD prevalence and notably, none looked at incidence.

Dead, polluted side/Green clear sky side
angkhan/Getty Images

The impact of climatic hazards on AD appears to vary depending on the geographic region and its baseline climate, the authors said. A study in South Korea, for instance, found that in areas declared as disaster zones after storms and heavy rains, the number of AD-related outpatient visits increased for all ages. And a study in the United States showed an increased prevalence of childhood eczema in states with higher mean annual precipitation. However, some other studies on precipitation found no associations.

Just as published studies on precipitation yielded mixed results, so have studies on warming temperatures, Dr. Abuabara and her colleagues reported in their paper, with higher temperatures found to be positively associated with severity of AD symptoms in a study among patients with AD living in a region of Southern Italy, but decreased AD-related health care utilization in a study in Denmark.

In another study of over 5,500 children enrolled in an eczema registry in the United States between 2004 and 2012, higher temperature (odds ratio [OR] = 0.90, P < .001) and increased sun exposure (OR = 0.93, P = .009) were associated with poorly controlled eczema, after the researchers controlled for gender, race, income, and topical medication use.



Studies From 10 Countries Reviewed

Across the 18 studies identified in the review, data were collected in 10 countries. Five studies were conducted in the United States, one used global data, six were from Asia, and the others were from Europe and Africa. Data are lacking, the researchers wrote, in many parts of the world, including coastal regions of the tropics that are projected to experience the largest cumulative climatic hazards.

Future research should not only cover more geographic areas — especially those most impacted by climate change — but should examine impacts on AD incidence, prevalence, and “long-term monitoring of disease activity over time at the individual level,” the researchers recommended. Research should also aim to integrate multiple climatic factors and types of climate data, they said.

“As researchers, we always like to distill things down, but with climatic hazards like warming, you have to integrate other factors such as what the baseline temperature is and how precipitation is involved,” Dr. Abuabara said in the interview. With precipitation, similarly, associated factors such as outdoor humidity, pollen, and pollution exposure may also be at play for AD. Overall, she said, “you have to integrate many types of data.”

In addition to their literature review, the researchers created maps comparing the past, present, and future burden of climatic hazards to AD prevalence data. One pair of maps illustrates global cumulative exposure to climatic hazards in 2005 in parallel with the estimated annual change in AD prevalence in the subsequent decade. “It’s meant to be descriptive,” Dr. Abuabara said in the interview. The maps show alignment “between the areas experiencing the most climatic hazards and those where we subsequently saw the most rapid changes in AD.”

The paper also describes how climatic factors impact skin physiology and AD — exacerbating barrier impairment, immune dysregulation, dysbiosis, and pruritus — and how there are differential impacts on vulnerable and displaced populations with AD. It also briefly addresses air pollution, which was not included in the review framework but is impacted by wildfire and other included climatic factors.
 

 

 

The Need to Better Track AD, Anticipate Clinical Impact

“Outside of epidemiology, [clinicians and others] may not realize we actually have fairly poor measures of prevalence and severity of AD and disease flare over time,” Dr. Abuabara said. So “improving the ways we can measure this disease and getting more detailed data is important” for assessing the impact of climate changes.

More skin measures should be incorporated into large national health surveys, for one. “Skin doesn’t come to mind as much as diseases like heart disease and diabetes,” she said, and when surveys ask about AD, “they often don’t ask specific enough questions or ask about severity.” The clinical impacts of adverse climatic changes and extreme weather events — sudden therapy interruption, particularly of systemic agents, and delayed treatment, for instance — should be reflected in the planning and provision of dermatology services, Dr. Abuabara and her coauthors wrote.

There are currently no evidence-based recommendations for what patients with AD can do differently when faced with wildfire smoke or other climatic hazards, other than general recommendations, for instance, to reduce exposure to wildfire smoke and aeroallergens, she said in the interview. But “overall, the field has moved to more proactive treatment patterns ... toward providing anticipatory guidance and having individualized treatment plans that give people the tools to be ready to step things up or counteract [flares or worsening] if they need to.”

She and her San Francisco–based coauthors have already experienced the impact of wildfires firsthand. “It was amazing — in the period right after a major wildfire hundreds of miles away from the Bay area, we saw a huge spike in visits for itch and for eczema,” she said, referring to research on AD clinic visits after the 2018 California Camp Fire. “It showed up dramatically in the data,” said Dr. Abuabara, one of the authors of that study.



The new review adds to a growing body of literature documenting health impacts of climate change and advocating for action. In September 2021, more than 230 medical journals, including the New England Journal of Medicine — though not any dermatology journals — published an editorial calling for emergency action to limit global warming and protect health.

The following year, a commentary published across four dermatology journals discussed current and future impacts of climate change and urged dermatologists to become more engaged in finding solutions to help mitigate and adapt to climate change.

More recently, dermatologists have published about the environmental impact of professional practices such as print journals and meeting samples using single-use plastics.

Dr. Abuabara disclosed to Allergy that she is a consultant for TARGET RWE and Amgen and that her institution receives grants for research from Pfizer and LaRoche Posay. Dr. Eichenfield reported serving as a scientific adviser, consultant, and/or study investigator for Pfizer, AbbVie, Amgen and other companies. Dr. Wang disclosed that she is an International Eczema Council Fellow with financial support from Abbvie. Other authors had multiple disclosures.

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Commentary: Medication Timing and Other Dupilumab Concerns, March 2024

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Wed, 03/13/2024 - 14:26
Dr. Feldman scans the journals, so you don’t have to!

Steven R. Feldman, MD, PhD
Ahn and colleagues found that having atopic dermatitis (AD) is associated with a higher risk for subsequent autoimmune disease. Is it a significant increased risk? What do we mean by "significant"? If we mean that the difference they observed wasn't likely due to chance alone, then yes, the observed difference was significant in the sense of being statistically significant. But what we really want to know is whether the difference they saw was large enough that someone with AD should lose sleep over it; I don't think they should. About six in 1000 patients per year without AD had a subsequent autoimmune disease; about eight in 1000 patients per year with AD had a subsequent autoimmune disease. There may be some genetic propensity to autoimmune disease in people with AD, but the great majority of people with AD, like the great majority of people in general, will not develop a subsequent autoimmune disease.

When skin diseases affect the palm or sole, they can have a disproportionately large negative effect on patients' lives. Hand and foot dermatitis can be disabling. Simpson and colleagues find that dupilumab is an effective treatment for AD of the hands and feet. Having safe and effective treatment for hand and foot dermatitis will be life-changing for many of our patients.

Patients often do very well with biologic treatment. When they do, they often wonder, Do I need to continue taking the medication? Lasheras-Pérez and colleagues found that the great majority of patients doing well taking dupilumab for AD could stretch out their dosing interval. I suspect a lot of our patients are doing this already. I used to worry that stretching out the dosing interval might lead to antidrug antibodies and loss of activity. Such loss of activity doesn't appear common. Because we also have multiple alternative treatments for severe AD, I think it may be quite reasonable for patients to try spreading out their doses after their disease has been well controlled for a good long time.

Superficial skin infections aren't rare in children, particularly children with AD. Paller and colleagues' study is informative about the safety of dupilumab in children. The drug, which blocks a pathway of the immune system, was associated with fewer infections. This is good news. The reduction in infections could be through restoring "immune balance" (whatever that means) or by improving skin barrier function. Perhaps the low rate of infection explains why dupilumab is not considered immunosuppressive.

I love studies of drug survival because I think that knowing the percentage of patients who stay with drug treatment is a good measure of overall safety and efficacy. Pezzolo and colleagues found — perhaps not surprisingly given the extraordinary efficacy of upadacitinib for AD — that almost no one discontinued the drug over 1.5 years due to lack of efficacy. There were patients who discontinued due to adverse events (and additional patients lost to follow-up who perhaps also discontinued the drug), but 80% of patients were still in the study at the end of 1.5 years. Three patients who weren't vaccinated for shingles developed shingles; encouraging patients to get the shingles vaccine may be a prudent measure when starting patients taking upadacitinib. 
 

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Steven R. Feldman, MD, PhD
Professor of Dermatology, Pathology and Social Sciences & Health Policy Wake Forest University School of Medicine, Winston-Salem, NC

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Steven R. Feldman, MD, PhD
Professor of Dermatology, Pathology and Social Sciences & Health Policy Wake Forest University School of Medicine, Winston-Salem, NC

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Professor of Dermatology, Pathology and Social Sciences & Health Policy Wake Forest University School of Medicine, Winston-Salem, NC

Dr. Feldman scans the journals, so you don’t have to!
Dr. Feldman scans the journals, so you don’t have to!

Steven R. Feldman, MD, PhD
Ahn and colleagues found that having atopic dermatitis (AD) is associated with a higher risk for subsequent autoimmune disease. Is it a significant increased risk? What do we mean by "significant"? If we mean that the difference they observed wasn't likely due to chance alone, then yes, the observed difference was significant in the sense of being statistically significant. But what we really want to know is whether the difference they saw was large enough that someone with AD should lose sleep over it; I don't think they should. About six in 1000 patients per year without AD had a subsequent autoimmune disease; about eight in 1000 patients per year with AD had a subsequent autoimmune disease. There may be some genetic propensity to autoimmune disease in people with AD, but the great majority of people with AD, like the great majority of people in general, will not develop a subsequent autoimmune disease.

When skin diseases affect the palm or sole, they can have a disproportionately large negative effect on patients' lives. Hand and foot dermatitis can be disabling. Simpson and colleagues find that dupilumab is an effective treatment for AD of the hands and feet. Having safe and effective treatment for hand and foot dermatitis will be life-changing for many of our patients.

Patients often do very well with biologic treatment. When they do, they often wonder, Do I need to continue taking the medication? Lasheras-Pérez and colleagues found that the great majority of patients doing well taking dupilumab for AD could stretch out their dosing interval. I suspect a lot of our patients are doing this already. I used to worry that stretching out the dosing interval might lead to antidrug antibodies and loss of activity. Such loss of activity doesn't appear common. Because we also have multiple alternative treatments for severe AD, I think it may be quite reasonable for patients to try spreading out their doses after their disease has been well controlled for a good long time.

Superficial skin infections aren't rare in children, particularly children with AD. Paller and colleagues' study is informative about the safety of dupilumab in children. The drug, which blocks a pathway of the immune system, was associated with fewer infections. This is good news. The reduction in infections could be through restoring "immune balance" (whatever that means) or by improving skin barrier function. Perhaps the low rate of infection explains why dupilumab is not considered immunosuppressive.

I love studies of drug survival because I think that knowing the percentage of patients who stay with drug treatment is a good measure of overall safety and efficacy. Pezzolo and colleagues found — perhaps not surprisingly given the extraordinary efficacy of upadacitinib for AD — that almost no one discontinued the drug over 1.5 years due to lack of efficacy. There were patients who discontinued due to adverse events (and additional patients lost to follow-up who perhaps also discontinued the drug), but 80% of patients were still in the study at the end of 1.5 years. Three patients who weren't vaccinated for shingles developed shingles; encouraging patients to get the shingles vaccine may be a prudent measure when starting patients taking upadacitinib. 
 

Steven R. Feldman, MD, PhD
Ahn and colleagues found that having atopic dermatitis (AD) is associated with a higher risk for subsequent autoimmune disease. Is it a significant increased risk? What do we mean by "significant"? If we mean that the difference they observed wasn't likely due to chance alone, then yes, the observed difference was significant in the sense of being statistically significant. But what we really want to know is whether the difference they saw was large enough that someone with AD should lose sleep over it; I don't think they should. About six in 1000 patients per year without AD had a subsequent autoimmune disease; about eight in 1000 patients per year with AD had a subsequent autoimmune disease. There may be some genetic propensity to autoimmune disease in people with AD, but the great majority of people with AD, like the great majority of people in general, will not develop a subsequent autoimmune disease.

When skin diseases affect the palm or sole, they can have a disproportionately large negative effect on patients' lives. Hand and foot dermatitis can be disabling. Simpson and colleagues find that dupilumab is an effective treatment for AD of the hands and feet. Having safe and effective treatment for hand and foot dermatitis will be life-changing for many of our patients.

Patients often do very well with biologic treatment. When they do, they often wonder, Do I need to continue taking the medication? Lasheras-Pérez and colleagues found that the great majority of patients doing well taking dupilumab for AD could stretch out their dosing interval. I suspect a lot of our patients are doing this already. I used to worry that stretching out the dosing interval might lead to antidrug antibodies and loss of activity. Such loss of activity doesn't appear common. Because we also have multiple alternative treatments for severe AD, I think it may be quite reasonable for patients to try spreading out their doses after their disease has been well controlled for a good long time.

Superficial skin infections aren't rare in children, particularly children with AD. Paller and colleagues' study is informative about the safety of dupilumab in children. The drug, which blocks a pathway of the immune system, was associated with fewer infections. This is good news. The reduction in infections could be through restoring "immune balance" (whatever that means) or by improving skin barrier function. Perhaps the low rate of infection explains why dupilumab is not considered immunosuppressive.

I love studies of drug survival because I think that knowing the percentage of patients who stay with drug treatment is a good measure of overall safety and efficacy. Pezzolo and colleagues found — perhaps not surprisingly given the extraordinary efficacy of upadacitinib for AD — that almost no one discontinued the drug over 1.5 years due to lack of efficacy. There were patients who discontinued due to adverse events (and additional patients lost to follow-up who perhaps also discontinued the drug), but 80% of patients were still in the study at the end of 1.5 years. Three patients who weren't vaccinated for shingles developed shingles; encouraging patients to get the shingles vaccine may be a prudent measure when starting patients taking upadacitinib. 
 

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Clinical Edge Journal Scan: Atopic Dermatitis, March 2024
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What Skin Manifestations Are Associated With Pediatric IBD?

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Thu, 02/22/2024 - 11:30

 

TOPLINE:

Skin conditions burden many children with inflammatory bowel disease (IBD), according to the authors of a single-center study.

METHODOLOGY:

  • Little is known about the prevalence of IBD-associated skin lesions and their association with IBD severity in children ages 18 and younger.Researchers retrospectively reviewed the medical charts of 425 children and adolescents with  (CD) or ulcerative  (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
  • Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
  • They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.
  • Researchers retrospectively reviewed the medical charts of 425 children and adolescents with Crohn’s disease (CD) or ulcerative colitis (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
  • Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
  • They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.

TAKEAWAY:

  • The most common noninfectious dermatologic condition among the 425 children and adolescents was  (30.8%), followed by eczema (15.8%) and perianal skin tags (14.6%).
  • Angular cheilitis was more common among those with CD than those with UC (7.2% vs 2%, respectively; P = .024) as was keratosis pilaris (6.9% vs 0.7%; P = .003), and perianal skin complications such as skin tags (20.3% vs 4%), fistulas (13.4% vs 2.7%), and abscesses (13.4% vs 2%; P < .001 for all associations).
  • Fungal skin infections were more frequently diagnosed in children with UC than those with CD (15.4% vs 8%; P = .017).
  • The researchers observed that the severity of IBD correlated with a higher prevalence of perianal fistula (P = .003), perianal region abscess (P = .041), psoriasis (P < .001), and pyoderma gangrenosum (P = .003).

IN PRACTICE:

“Early identification of common dermatologic conditions in children and adolescents with IBD and recognizing their characteristic associations may alter management and improve skin-related outcomes in this patient population,” the authors wrote.

SOURCE:

Corresponding author Megha M. Tollefson, MD, of the Department of Dermatology at Mayo Clinic, Rochester, Minnesota, and colleagues conducted the research, which was published in Pediatric Dermatology.

LIMITATIONS:

The single-center design and the fact that database studies are subject to extraction error. There was no age- and sex-matched cohort to determine whether the prevalence of cutaneous infections, acne, eczema, and other inflammatory disorders was truly increased in IBD.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

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TOPLINE:

Skin conditions burden many children with inflammatory bowel disease (IBD), according to the authors of a single-center study.

METHODOLOGY:

  • Little is known about the prevalence of IBD-associated skin lesions and their association with IBD severity in children ages 18 and younger.Researchers retrospectively reviewed the medical charts of 425 children and adolescents with  (CD) or ulcerative  (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
  • Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
  • They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.
  • Researchers retrospectively reviewed the medical charts of 425 children and adolescents with Crohn’s disease (CD) or ulcerative colitis (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
  • Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
  • They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.

TAKEAWAY:

  • The most common noninfectious dermatologic condition among the 425 children and adolescents was  (30.8%), followed by eczema (15.8%) and perianal skin tags (14.6%).
  • Angular cheilitis was more common among those with CD than those with UC (7.2% vs 2%, respectively; P = .024) as was keratosis pilaris (6.9% vs 0.7%; P = .003), and perianal skin complications such as skin tags (20.3% vs 4%), fistulas (13.4% vs 2.7%), and abscesses (13.4% vs 2%; P < .001 for all associations).
  • Fungal skin infections were more frequently diagnosed in children with UC than those with CD (15.4% vs 8%; P = .017).
  • The researchers observed that the severity of IBD correlated with a higher prevalence of perianal fistula (P = .003), perianal region abscess (P = .041), psoriasis (P < .001), and pyoderma gangrenosum (P = .003).

IN PRACTICE:

“Early identification of common dermatologic conditions in children and adolescents with IBD and recognizing their characteristic associations may alter management and improve skin-related outcomes in this patient population,” the authors wrote.

SOURCE:

Corresponding author Megha M. Tollefson, MD, of the Department of Dermatology at Mayo Clinic, Rochester, Minnesota, and colleagues conducted the research, which was published in Pediatric Dermatology.

LIMITATIONS:

The single-center design and the fact that database studies are subject to extraction error. There was no age- and sex-matched cohort to determine whether the prevalence of cutaneous infections, acne, eczema, and other inflammatory disorders was truly increased in IBD.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Skin conditions burden many children with inflammatory bowel disease (IBD), according to the authors of a single-center study.

METHODOLOGY:

  • Little is known about the prevalence of IBD-associated skin lesions and their association with IBD severity in children ages 18 and younger.Researchers retrospectively reviewed the medical charts of 425 children and adolescents with  (CD) or ulcerative  (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
  • Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
  • They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.
  • Researchers retrospectively reviewed the medical charts of 425 children and adolescents with Crohn’s disease (CD) or ulcerative colitis (UC) at one or more dermatologic diagnoses who were seen at Mayo Clinic, Rochester, Minnesota, between 1999 and 2017.
  • Of the children studied, 53% were male, 64.9% had CD, and 42.8% had one or more cutaneous infections.
  • They used the chi-square/Fischer’s exact test to compare categorical outcomes between patients with CD and UC and to detect differences in IBD/CD/UC disease severity and skin conditions.

TAKEAWAY:

  • The most common noninfectious dermatologic condition among the 425 children and adolescents was  (30.8%), followed by eczema (15.8%) and perianal skin tags (14.6%).
  • Angular cheilitis was more common among those with CD than those with UC (7.2% vs 2%, respectively; P = .024) as was keratosis pilaris (6.9% vs 0.7%; P = .003), and perianal skin complications such as skin tags (20.3% vs 4%), fistulas (13.4% vs 2.7%), and abscesses (13.4% vs 2%; P < .001 for all associations).
  • Fungal skin infections were more frequently diagnosed in children with UC than those with CD (15.4% vs 8%; P = .017).
  • The researchers observed that the severity of IBD correlated with a higher prevalence of perianal fistula (P = .003), perianal region abscess (P = .041), psoriasis (P < .001), and pyoderma gangrenosum (P = .003).

IN PRACTICE:

“Early identification of common dermatologic conditions in children and adolescents with IBD and recognizing their characteristic associations may alter management and improve skin-related outcomes in this patient population,” the authors wrote.

SOURCE:

Corresponding author Megha M. Tollefson, MD, of the Department of Dermatology at Mayo Clinic, Rochester, Minnesota, and colleagues conducted the research, which was published in Pediatric Dermatology.

LIMITATIONS:

The single-center design and the fact that database studies are subject to extraction error. There was no age- and sex-matched cohort to determine whether the prevalence of cutaneous infections, acne, eczema, and other inflammatory disorders was truly increased in IBD.

DISCLOSURES:

The researchers reported having no disclosures.

A version of this article appeared on Medscape.com.

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Company Announces Regulatory Filing for Nemolizumab for Two Indications

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Changed
Tue, 02/20/2024 - 15:30

On February 14, 2024, Galderma announced that the Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis.

A first-in-class investigational monoclonal antibody specifically designed to inhibit interleukin (IL) IL-31 signaling, nemolizumab has also been granted FDA Priority Review for prurigo nodularis, according to a press release from the company. The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab for both prurigo nodularis and atopic dermatitis.


The regulatory developments follow data from the phase III OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis (NCT04501679 and NCT04501666). According to the press release, in OLYMPIA 1 and 2, 58% and 56% of patients, respectively, achieved at least a least four-point reduction in itch intensity as measured by the peak-pruritus numerical rating scale (PP-NRS), compared with 17% and 21% in the placebo groups (P < .0001). At the same time, 26% and 38% of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions on the investigator’s global assessment (IGA) score, compared with 7% and 11% in the placebo groups (P < .0001).

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On February 14, 2024, Galderma announced that the Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis.

A first-in-class investigational monoclonal antibody specifically designed to inhibit interleukin (IL) IL-31 signaling, nemolizumab has also been granted FDA Priority Review for prurigo nodularis, according to a press release from the company. The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab for both prurigo nodularis and atopic dermatitis.


The regulatory developments follow data from the phase III OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis (NCT04501679 and NCT04501666). According to the press release, in OLYMPIA 1 and 2, 58% and 56% of patients, respectively, achieved at least a least four-point reduction in itch intensity as measured by the peak-pruritus numerical rating scale (PP-NRS), compared with 17% and 21% in the placebo groups (P < .0001). At the same time, 26% and 38% of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions on the investigator’s global assessment (IGA) score, compared with 7% and 11% in the placebo groups (P < .0001).

On February 14, 2024, Galderma announced that the Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for nemolizumab for the treatment of patients with prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis.

A first-in-class investigational monoclonal antibody specifically designed to inhibit interleukin (IL) IL-31 signaling, nemolizumab has also been granted FDA Priority Review for prurigo nodularis, according to a press release from the company. The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab for both prurigo nodularis and atopic dermatitis.


The regulatory developments follow data from the phase III OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis (NCT04501679 and NCT04501666). According to the press release, in OLYMPIA 1 and 2, 58% and 56% of patients, respectively, achieved at least a least four-point reduction in itch intensity as measured by the peak-pruritus numerical rating scale (PP-NRS), compared with 17% and 21% in the placebo groups (P < .0001). At the same time, 26% and 38% of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions on the investigator’s global assessment (IGA) score, compared with 7% and 11% in the placebo groups (P < .0001).

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