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BMI May Influence Short-Term Therapeutic Response to Dupilumab in Adults With Atopic Dermatitis

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Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.

Major finding: At week 16, patients with BMI ≥ 25 kg/m2 vs those with BMI < 25 kg/m2 showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.

Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m2 or ≥ 25 kg/m2 who received dupilumab.

Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.

Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source

 

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Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.

Major finding: At week 16, patients with BMI ≥ 25 kg/m2 vs those with BMI < 25 kg/m2 showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.

Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m2 or ≥ 25 kg/m2 who received dupilumab.

Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.

Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source

 

Key clinical point: A higher body mass index (BMI) was associated with short-term reduction in the efficacy of dupilumab in patients with moderate to severe atopic dermatitis (AD), with no effect on long-term efficacy.

Major finding: At week 16, patients with BMI ≥ 25 kg/m2 vs those with BMI < 25 kg/m2 showed a significantly reduced improvement in Eczema Area Severity Index (P < .001), Pruritus Numerical Rating Scale (P < .05), and Dermatology Life Quality Index (P < .05) scores, but improvements were comparable at weeks 24 and 52. However, all patients showed significant improvement in all scores from baseline to week 16, which was sustained till week 52.

Study details: This single-center, retrospective study included 839 adult patients with moderate to severe AD and a BMI < 25 kg/m2 or ≥ 25 kg/m2 who received dupilumab.

Disclosures: This study did not receive any funding. Two authors declared serving as investigators, speakers, consultants, or advisory board members for various sources.

Source: Patruno C, Potestio L, Cecere D, et al. The impact of body mass index on dupilumab treatment outcomes in adult atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2024 (May 19). doi: 10.1111/jdv.20111 Source

 

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Lebrikizumab Improves Skin Symptoms in Adolescents With Atopic Dermatitis

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Key clinical point: Lebrikizumab monotherapy significantly improved skin symptoms and itch in adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 16, a higher proportion of patients treated with lebrikizumab vs placebo in ADvocate 1 and 2 achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-point improvement from baseline (46.6% vs 14.3%) and at least a 75% improvement in the Eczema Area and Severity Index score (62.0% vs 17.3%), with improvements observed as early as week 4 (all P < .05). Consistent corresponding results were observed for ADhere.

Study details: This post hoc analysis of the ADvocate 1 and 2 trials and ADhere trial included 148 adolescents with moderate to severe AD who were randomly assigned to receive subcutaneous lebrikizumab or placebo alone in ADvocate 1 and 2 or combined with topical corticosteroids in ADhere.

Disclosures: The three trials were funded by Dermira, Inc., a subsidiary wholly owned by Eli Lilly and Company. Four authors declared being employees of Eli Lilly and Company. Several authors declared being consultants or speakers for or having other ties with various sources, including Eli Lilly and Company.

Source: Hebert AA, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. J Dermatolog Treat. 2024;35:2324833. doi: 10.1080/09546634.2024.2324833 Source

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Key clinical point: Lebrikizumab monotherapy significantly improved skin symptoms and itch in adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 16, a higher proportion of patients treated with lebrikizumab vs placebo in ADvocate 1 and 2 achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-point improvement from baseline (46.6% vs 14.3%) and at least a 75% improvement in the Eczema Area and Severity Index score (62.0% vs 17.3%), with improvements observed as early as week 4 (all P < .05). Consistent corresponding results were observed for ADhere.

Study details: This post hoc analysis of the ADvocate 1 and 2 trials and ADhere trial included 148 adolescents with moderate to severe AD who were randomly assigned to receive subcutaneous lebrikizumab or placebo alone in ADvocate 1 and 2 or combined with topical corticosteroids in ADhere.

Disclosures: The three trials were funded by Dermira, Inc., a subsidiary wholly owned by Eli Lilly and Company. Four authors declared being employees of Eli Lilly and Company. Several authors declared being consultants or speakers for or having other ties with various sources, including Eli Lilly and Company.

Source: Hebert AA, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. J Dermatolog Treat. 2024;35:2324833. doi: 10.1080/09546634.2024.2324833 Source

Key clinical point: Lebrikizumab monotherapy significantly improved skin symptoms and itch in adolescents with moderate to severe atopic dermatitis (AD).

Major finding: At week 16, a higher proportion of patients treated with lebrikizumab vs placebo in ADvocate 1 and 2 achieved an Investigator’s Global Assessment score of 0 or 1 with at least a two-point improvement from baseline (46.6% vs 14.3%) and at least a 75% improvement in the Eczema Area and Severity Index score (62.0% vs 17.3%), with improvements observed as early as week 4 (all P < .05). Consistent corresponding results were observed for ADhere.

Study details: This post hoc analysis of the ADvocate 1 and 2 trials and ADhere trial included 148 adolescents with moderate to severe AD who were randomly assigned to receive subcutaneous lebrikizumab or placebo alone in ADvocate 1 and 2 or combined with topical corticosteroids in ADhere.

Disclosures: The three trials were funded by Dermira, Inc., a subsidiary wholly owned by Eli Lilly and Company. Four authors declared being employees of Eli Lilly and Company. Several authors declared being consultants or speakers for or having other ties with various sources, including Eli Lilly and Company.

Source: Hebert AA, Flohr C, Hong HC, et al. Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials. J Dermatolog Treat. 2024;35:2324833. doi: 10.1080/09546634.2024.2324833 Source

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Dupilumab Offers Long-Term Safety and Sustained Efficacy in Pediatric Atopic Dermatitis

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Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).

Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.

Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.

Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source

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Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).

Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.

Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.

Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source

Key clinical point: Dupilumab demonstrated sustained clinical benefits and an acceptable long-term safety profile in children age 6 months to 5 years with uncontrolled moderate to severe atopic dermatitis (AD).

Major finding: At week 52, 36.2% of patients achieved an Investigator’s Global Assessment score of 0 or 1, and 96.6%, 79.3%, and 58.6% of patients achieved at least a 50%, 75%, and 90% improvement in the Eczema Area and Severity Index score, respectively. Overall, 78.2% of patients reported one or more treatment-emergent adverse events, most of mild or moderate severity.

Study details: Findings are from the phase 3 LIBERTY AD PED-OLE study that included 142 children with moderate to severe AD who had previously participated in the LIBERTY AD PRESCHOOL part B study and received a weight-tiered dose of 200 mg or 300 mg of subcutaneous dupilumab every 4 weeks.

Disclosures: The study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Five authors declared being employees of or holding stocks or stock options in Sanofi or Regeneron. The other authors declared having ties with various sources, including Sanofi and Regeneron.

Source: Paller AS, Siegfried EC, Simpson EL, et al. Dupilumab safety and efficacy up to 1 year in children aged 6 months to 5 years with atopic dermatitis: Results from a phase 3 open-label extension study. Am J Clin Dermatol. 2024 (May 14). doi: 10.1007/s40257-024-00859-y Source

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Parental E-Cigarette Use Linked With Higher Risk for Pediatric Atopic Dermatitis

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Key clinical point: Use of e-cigarettes by parents is associated with an increased risk for atopic dermatitis (AD) in children.

Major finding: The prevalence of parental e-cigarette use was 18.0% (95% CI 16.5%-19.0%) among children with AD and 14.4% (95% CI 13.9%-15.0%) among those without AD. The risk for AD was significantly higher in children whose parents used e-cigarettes (adjusted odds ratio 1.24; P = .002).

Study details: This retrospective, cross-sectional analysis of data from the US National Health Interview Survey (2014-2018) included 48,637,111 children (age < 18 years), of whom 6,354,515 had a history of AD.

Disclosures: This study did not receive specific funding from any sources. Albert S. Chiou declared receiving consultation fees from Corvus Therapeutics outside the submitted work.

Source: Youn GM, Sarin KY, Chiou AS, et al. Parental e-cigarette use and pediatric atopic dermatitis. JAMA Dermatol. 2024 (May 22). doi: 10.1001/jamadermatol.2024.1283 Source

 

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Key clinical point: Use of e-cigarettes by parents is associated with an increased risk for atopic dermatitis (AD) in children.

Major finding: The prevalence of parental e-cigarette use was 18.0% (95% CI 16.5%-19.0%) among children with AD and 14.4% (95% CI 13.9%-15.0%) among those without AD. The risk for AD was significantly higher in children whose parents used e-cigarettes (adjusted odds ratio 1.24; P = .002).

Study details: This retrospective, cross-sectional analysis of data from the US National Health Interview Survey (2014-2018) included 48,637,111 children (age < 18 years), of whom 6,354,515 had a history of AD.

Disclosures: This study did not receive specific funding from any sources. Albert S. Chiou declared receiving consultation fees from Corvus Therapeutics outside the submitted work.

Source: Youn GM, Sarin KY, Chiou AS, et al. Parental e-cigarette use and pediatric atopic dermatitis. JAMA Dermatol. 2024 (May 22). doi: 10.1001/jamadermatol.2024.1283 Source

 

Key clinical point: Use of e-cigarettes by parents is associated with an increased risk for atopic dermatitis (AD) in children.

Major finding: The prevalence of parental e-cigarette use was 18.0% (95% CI 16.5%-19.0%) among children with AD and 14.4% (95% CI 13.9%-15.0%) among those without AD. The risk for AD was significantly higher in children whose parents used e-cigarettes (adjusted odds ratio 1.24; P = .002).

Study details: This retrospective, cross-sectional analysis of data from the US National Health Interview Survey (2014-2018) included 48,637,111 children (age < 18 years), of whom 6,354,515 had a history of AD.

Disclosures: This study did not receive specific funding from any sources. Albert S. Chiou declared receiving consultation fees from Corvus Therapeutics outside the submitted work.

Source: Youn GM, Sarin KY, Chiou AS, et al. Parental e-cigarette use and pediatric atopic dermatitis. JAMA Dermatol. 2024 (May 22). doi: 10.1001/jamadermatol.2024.1283 Source

 

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High Sodium Intake Linked to Increased Atopic Dermatitis Risk

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Key clinical point: High dietary intake of sodium, estimated according to 24-hour urinary sodium excretion, was associated with a greater likelihood of atopic dermatitis (AD) diagnosis, having active AD, and increasing severity of AD.

Major finding: A 1-g increase in estimated 24-hour urine sodium excretion was associated with an increased likelihood of AD (adjusted odds ratio [aOR] 1.11; 95% CI 1.07-1.14), active AD (aOR 1.16; 95% CI 1.05-1.28), and increasing AD severity (aOR 1.11; 95% CI 1.07-1.15).

Study details: This cross-sectional study evaluated the association between high levels of dietary sodium intake and AD prevalence, activity, and severity in 215,832 adults from the UK Biobank cohort, of whom 10,839 had AD.

Disclosures: This study was supported by grants from the Medical Student in Aging Research Program and US National Institute on Aging and by the National Eczema Association. One author declared receiving research funding to her institution and consulting fees from various sources.

Source: Chiang BM, Ye M, Chattopadhyay A, et al. Sodium intake and atopic dermatitis. JAMA Dermatol. 2024 (Jun 5). doi: 10.1001/jamadermatol.2024.1544 Source

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Key clinical point: High dietary intake of sodium, estimated according to 24-hour urinary sodium excretion, was associated with a greater likelihood of atopic dermatitis (AD) diagnosis, having active AD, and increasing severity of AD.

Major finding: A 1-g increase in estimated 24-hour urine sodium excretion was associated with an increased likelihood of AD (adjusted odds ratio [aOR] 1.11; 95% CI 1.07-1.14), active AD (aOR 1.16; 95% CI 1.05-1.28), and increasing AD severity (aOR 1.11; 95% CI 1.07-1.15).

Study details: This cross-sectional study evaluated the association between high levels of dietary sodium intake and AD prevalence, activity, and severity in 215,832 adults from the UK Biobank cohort, of whom 10,839 had AD.

Disclosures: This study was supported by grants from the Medical Student in Aging Research Program and US National Institute on Aging and by the National Eczema Association. One author declared receiving research funding to her institution and consulting fees from various sources.

Source: Chiang BM, Ye M, Chattopadhyay A, et al. Sodium intake and atopic dermatitis. JAMA Dermatol. 2024 (Jun 5). doi: 10.1001/jamadermatol.2024.1544 Source

Key clinical point: High dietary intake of sodium, estimated according to 24-hour urinary sodium excretion, was associated with a greater likelihood of atopic dermatitis (AD) diagnosis, having active AD, and increasing severity of AD.

Major finding: A 1-g increase in estimated 24-hour urine sodium excretion was associated with an increased likelihood of AD (adjusted odds ratio [aOR] 1.11; 95% CI 1.07-1.14), active AD (aOR 1.16; 95% CI 1.05-1.28), and increasing AD severity (aOR 1.11; 95% CI 1.07-1.15).

Study details: This cross-sectional study evaluated the association between high levels of dietary sodium intake and AD prevalence, activity, and severity in 215,832 adults from the UK Biobank cohort, of whom 10,839 had AD.

Disclosures: This study was supported by grants from the Medical Student in Aging Research Program and US National Institute on Aging and by the National Eczema Association. One author declared receiving research funding to her institution and consulting fees from various sources.

Source: Chiang BM, Ye M, Chattopadhyay A, et al. Sodium intake and atopic dermatitis. JAMA Dermatol. 2024 (Jun 5). doi: 10.1001/jamadermatol.2024.1544 Source

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Study Finds Major CV Event Risk in Patients With AD Similar to Controls

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Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

Christopher G. Bunick, MD, PhD, a dermatologist at Yale University, New Haven, Conn.
Dr. Christopher G. Bunick

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

 

 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”



In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

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Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

Christopher G. Bunick, MD, PhD, a dermatologist at Yale University, New Haven, Conn.
Dr. Christopher G. Bunick

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

 

 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”



In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

Patients with atopic dermatitis (AD) had a lower risk for major adverse cardiovascular events (MACE) than the general population, and this risk was significantly lower than that of patients with rheumatoid arthritis (RA), according to an analysis of national claims data.

The results of the analysis were presented during a poster session at the Revolutionizing Atopic Dermatitis conference in Chicago. “While it is known that atopic dermatitis is associated with some comorbidities, the specific risk of major adverse cardiovascular events in patients with AD, especially those with moderate to severe AD within the US population, is unclear,” the study’s first author Christopher G. Bunick, MD, PhD, said in an interview following the conference.

Christopher G. Bunick, MD, PhD, a dermatologist at Yale University, New Haven, Conn.
Dr. Christopher G. Bunick

To characterize the risk for MACE in patients with AD vs matched controls without AD (non-AD) and patients with RA, Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut, and colleagues retrospectively evaluated US claims data from Optum’s Clinformatics Data Mart. The study population consisted of 381,221 patients aged 18 years and older who were diagnosed with AD from March 2017 to March 2023. Comparator groups included 381,221 non-AD controls matched by age, sex, and cohort entry, and 97,445 patients diagnosed with RA based on at least two claims for RA ≥ 7 days apart.

Patients were classified as having moderate to severe disease if they received dupilumab for AD or advanced systemic therapy for RA at any time during the follow-up period. The matched moderate to severe AD and non-AD cohorts were composed of 7134 patients each. The incidence of MACE was defined as inpatient hospitalization with myocardial infarction or stroke. The researchers used multivariable Cox proportional hazard models adjusted for baseline demographics, comorbidities, and medications to calculate the relative risk for MACE.
 

MACE Incidence, Relative Risk

The mean age of the AD cohort and non-AD matched controls was 58 years, and the mean age of the RA cohort was 67 years. The incidence of MACE per 100 patient-years was 1.78 among patients with AD, 1.83 among non-AD matched controls, and 2.12 among patients with RA. Patients with moderate to severe AD had a MACE incidence of 1.18 per 100 patient-years, which was lower than that of non-AD matched controls (1.52) and patients with moderate to severe RA (1.67).

In other findings, the relative risk for MACE in patients with AD was lower vs non-AD controls (adjusted hazard ratio [aHR], 0.91; 95% CI, 0.89-0.93; P < .001) and patients with RA (aHR, 0.83; 95% CI, 0.80-0.85; P < .001). Among patients with moderate to severe AD, MACE risk was similar to that of non-AD matched controls (aHR, 0.92; 95% CI, 0.73-1.14) and lower vs those with moderate to severe RA (aHR, 0.83; 95% CI, 0.73-0.94; P < .01).

MACE risk associated with AD was greater in patients who were older (per year, aHR, 1.05; 95% CI, 1.05-1.05), male (aHR, 0.81; 95% CI, 0.79-0.84), and Black vs White (aHR, 1.16; 95% CI, 1.11-1.21), and among those who received systemic corticosteroids in the 3 months before diagnosis (aHR, 1.10; 95% CI, 1.06-1.14), were hospitalized in the year before diagnosis (aHR, 1.35; 95% CI, 1.30-1.41), and had a history of smoking (aHR, 1.20; 95% CI, 1.16-1.24) and drug abuse (aHR, 1.34; 95% CI, 1.25-1.43).
 

 

 

Unexpected Results

“One surprising finding was that the incidence of MACE in patients with moderate to severe AD was actually lower than that in non-AD matched controls and significantly lower compared to patients with moderate to severe RA,” Dr. Bunick said. “This contrasts with the expectation that increased systemic inflammation in moderate to severe AD would correspond with a higher incidence of MACE.”

Another unexpected result, he said, was that, among patients with moderate to severe AD, the risk for MACE was not significantly different from that of non-AD matched controls, suggesting that the inflammatory burden in AD might not translate to as high a cardiovascular risk as previously assumed.

Dr. Bunick noted that advanced treatments for AD such as Janus kinase (JAK) inhibitors (upadacitinib and abrocitinib) have a class boxed warning for MACE based on a study of another JAK inhibitor (tofacitinib) in patients with RA, but “this may not apply to AD because patients with AD have a lower risk for MACE.”



In his opinion, he said, the study “underscores the importance of understanding the specific risks associated with different inflammatory conditions.” Moreover, “it emphasizes the potential benefits of newer systemic therapies in potentially mitigating cardiovascular risks in patients with moderate to severe AD.”

Dr. Bunick acknowledged certain limitations of the study, including its retrospective design and reliance on administrative claims data, which “may introduce coding errors and misclassification,” and the generalizability of the results, which may be limited to the US population.

AbbVie funded the study, and three of the coauthors are employees of the company. Dr. Bunick disclosed that he has served as an investigator and/or a consultant for AbbVie, Almirall, Apogee, Arcutis Biotherapeutics, Connect Biopharma, Daiichi Sankyo, EPI Health/Novan, LEO, Lilly, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer, Sanofi Regeneron, Sun, Takeda, Timber, and UCB.

A version of this article appeared on Medscape.com.

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Atopic Dermatitis: Study Compares Prevalence by Gender, Age, and Ethnic Background

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Mon, 06/24/2024 - 09:22

In the United States, the prevalence of patient-reported atopic dermatitis (AD) is higher in children and adult women, while Hispanic adults have a lower prevalence of AD than adults from other ethnic backgrounds.

Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.

“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.

Dr. Raj Chovatiya, department of dermatology, Northwestern University, Chicago
Dr. Chovatiya
Dr. Raj Chovatiya

“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”

Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.

More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.

In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.

When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.



On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).

“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”

Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”

In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”

Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.

A version of this article appeared on Medscape.com .

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In the United States, the prevalence of patient-reported atopic dermatitis (AD) is higher in children and adult women, while Hispanic adults have a lower prevalence of AD than adults from other ethnic backgrounds.

Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.

“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.

Dr. Raj Chovatiya, department of dermatology, Northwestern University, Chicago
Dr. Chovatiya
Dr. Raj Chovatiya

“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”

Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.

More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.

In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.

When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.



On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).

“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”

Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”

In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”

Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.

A version of this article appeared on Medscape.com .

In the United States, the prevalence of patient-reported atopic dermatitis (AD) is higher in children and adult women, while Hispanic adults have a lower prevalence of AD than adults from other ethnic backgrounds.

Those are among the key findings from an analysis of nationally representative cross-sectional data that were presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis conference in Chicago.

“In the past few years, there has been a much-needed focus on better understanding disparities in atopic dermatitis,” one of the study authors, Raj Chovatiya, MD, PhD, clinical associate professor at Chicago Medical School, Rosalind Franklin University, North Chicago, told this news organization after the conference.

Dr. Raj Chovatiya, department of dermatology, Northwestern University, Chicago
Dr. Chovatiya
Dr. Raj Chovatiya

“Epidemiology is one of the key ways in which we can query differences in AD at a population level.”

Drawing from the 2021 National Health Interview Survey, the researchers identified 3103 respondents who reported being diagnosed with AD or eczema. They estimated the prevalence rates of AD for the overall population and each subgroup by dividing US frequency estimates by their corresponding US population totals and used multivariable logistic regression to assess the odds of having AD.

More than half of the respondents (1643) were aged between 18 and 64 years, 522 were aged 65 years and older, and 922 were children younger than 18 years. Overall, the prevalence of AD was 7.6% in adults aged 18-64 years and 6.1% in adults aged 65 years and older, for a weighted US estimate of 15.3 and 3.2 million, respectively. The prevalence of AD varied by race/ethnicity and was highest for those from “other single and multiple races” group (12.4%), followed by Black/African American (8.5%), White (7.7%), Asian (6.5%), American Indian/Alaskan Native (4.9%), and Hispanic (4.8%) populations.

In children, race/ethnicity prevalence were highest for those from other single and multiple races (15.2.%), followed by Black/African American (14.2%), American Indian/Alaskan Native (12%), White (10.2%), Hispanic (9.5%), and Asian (9%) populations.

When the researchers combined all age groups, they observed higher prevalence rates of AD among females than among males. However, in an analysis limited to children, the prevalence rates were similar between girls and boys (10.8% vs 10.7%, respectively), for a weighted US estimate of 7.8 million children with AD.



On multiple regression, the odds of having AD were greater among women than among men (odds ratio [OR], 1.4), among adults aged 18-64 years than among those aged 65 years and older (OR, 1.4), among those younger than 18 years than among those aged 65 years and older (OR, 2.0), and among Black/African American individuals than among White individuals (OR, 1.2). Hispanic adults had a lower risk for AD than non-Hispanic White adults (OR, 0.69) as did Asian adults than White adults (OR, 0.82).

“We found AD prevalence rates were higher in children and adult females, Hispanic adults had a lower prevalence of AD than all other adult groups, and there were numerical differences in AD prevalence across racial groups,” Dr. Chovatiya said in the interview. “While there are of course limitations to the use of any nationally representative cross-sectional dataset that requires weighting to project results from a smaller sample to reflect a larger more heterogeneous group, these results are important for us to consider targeted strategies to address AD burden.”

Jonathan I. Silverberg, MD, PhD, professor of dermatology at The George Washington University, Washington, who was asked to comment on the study, said that while the prevalence of AD in children has been well documented in prior research, “this study fills an important gap by showing us that the prevalence does remain high in adults.”

In addition, “it has not shown any evidence of AD decreasing over time; if anything, it might be slightly increasing,” he said. “We’re also seeing differences [in AD] by race and ethnicity. We have seen that demonstrated in children but [has been] less clearly demonstrated in adults.”

Eli Lilly and Company funded the analysis. Dr. Chovatiya and Dr. Silverberg disclosed ties to several pharmaceutical companies, including Eli Lilly.

A version of this article appeared on Medscape.com .

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Topical Ruxolitinib Effective for AD in Study of Children Ages 2-11 years

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Changed
Mon, 06/24/2024 - 09:06

Treatment with topical ruxolitinib cream 1.5% showed good tolerability and was effective over the course of 52 weeks in children aged 2-11 years with atopic dermatitis (AD) affecting ≥ 35% or more of their body surface area (BSA), results from a small open-label maximum-use trial showed.

When approved for this age group, ruxolitinib cream will provide a topical nonsteroidal option for patients aged 2-11, which will “simplify the treatment regimen,” one of the study investigators, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session.

Dr. Linda Stein Gold, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit.
Dr. Stein Gold
Dr. Linda Stein Gold

A topical formulation of the selective Janus kinase (JAK) 1/JAK2 inhibitor, ruxolitinib cream 1.5% is currently approved by the Food and Drug Administration for the short-term and noncontinuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients aged 12 years and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In previous reports of this trial in children aged 2-11 years with ≥ 35% affected BSA, ruxolitinib cream 1.5% was generally well tolerated, with rapid anti-inflammatory and antipruritic effects and improvements in patient-reported outcomes observed with ≤ 4 weeks of continuous treatment and maintained with as-needed treatment from 4 to 8 weeks.

For the current trial, investigators evaluated data on tolerability, safety, systemic exposure, and clinical and patient-reported outcomes through 52 weeks to determine whether clinical benefits and tolerability observed through 8 weeks were sustained.

Dr. Stein Gold and colleagues reported results from 29 children who received ruxolitinib cream 1.5% from baseline through week 8. Of these, 22 continued into the long-term safety period from week 8 through 52. From baseline through week 8, patients applied a mean of 6.5 g per day of ruxolitinib cream; this dropped to a mean of 3.2 g per day from weeks 8 through 52. The mean steady-state plasma concentration of ruxolitinib throughout the study was 98.2 nM, which is “well below half-maximal concentration of JAK-mediated myelosuppression in adults (281 nM),” the researchers stated in their abstract.



No treatment-related interruptions, discontinuations, or serious adverse events were observed between baseline and week 52. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis). At weeks 4 and 52, 53.8% of patients achieved treatment success, which was defined as an Investigator Global Assessment of 0/1 with a ≥ 2-grade improvement from baseline. The mean affected BSA decreased from 58.0% at baseline to 11.4% at week 4 and continued to decrease to 2.2% through week 52. “I was surprised that patients could maintain control over the long-term using the medication as needed,” Dr. Stein Gold told this news organization. “I was also pleased to see that there was low systemic exposure even when used on large body surface areas.”

In other findings, the mean total Patient Oriented Eczema Measure score dropped from a baseline of 19.4 to a mean of 4.5 at week 8 and 3.6 at week 52 and the mean total Children’s Dermatology Life Quality Index score fell from a baseline of 15.4 to a mean of 5.3 at week 8 and a mean of 2.1 at week 52. Meanwhile, the mean total Infants’ Dermatology Quality of Life Index score fell from a mean of 12.3 at baseline to a mean of 2.8 at week 8 and a mean of 0.7 at week 52.

Dr. Stein Gold noted certain limitations of the study, including the fact that it did not study children aged younger than 2 years.

The study was funded by Incyte, which markets ruxolitinib cream 1.5% as Opzelura. Dr. Stein Gold disclosed that she has served as an investigator, advisor, and/or speaker for several pharmaceutical companies, including Incyte.

A version of this article appeared on Medscape.com.

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Treatment with topical ruxolitinib cream 1.5% showed good tolerability and was effective over the course of 52 weeks in children aged 2-11 years with atopic dermatitis (AD) affecting ≥ 35% or more of their body surface area (BSA), results from a small open-label maximum-use trial showed.

When approved for this age group, ruxolitinib cream will provide a topical nonsteroidal option for patients aged 2-11, which will “simplify the treatment regimen,” one of the study investigators, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session.

Dr. Linda Stein Gold, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit.
Dr. Stein Gold
Dr. Linda Stein Gold

A topical formulation of the selective Janus kinase (JAK) 1/JAK2 inhibitor, ruxolitinib cream 1.5% is currently approved by the Food and Drug Administration for the short-term and noncontinuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients aged 12 years and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In previous reports of this trial in children aged 2-11 years with ≥ 35% affected BSA, ruxolitinib cream 1.5% was generally well tolerated, with rapid anti-inflammatory and antipruritic effects and improvements in patient-reported outcomes observed with ≤ 4 weeks of continuous treatment and maintained with as-needed treatment from 4 to 8 weeks.

For the current trial, investigators evaluated data on tolerability, safety, systemic exposure, and clinical and patient-reported outcomes through 52 weeks to determine whether clinical benefits and tolerability observed through 8 weeks were sustained.

Dr. Stein Gold and colleagues reported results from 29 children who received ruxolitinib cream 1.5% from baseline through week 8. Of these, 22 continued into the long-term safety period from week 8 through 52. From baseline through week 8, patients applied a mean of 6.5 g per day of ruxolitinib cream; this dropped to a mean of 3.2 g per day from weeks 8 through 52. The mean steady-state plasma concentration of ruxolitinib throughout the study was 98.2 nM, which is “well below half-maximal concentration of JAK-mediated myelosuppression in adults (281 nM),” the researchers stated in their abstract.



No treatment-related interruptions, discontinuations, or serious adverse events were observed between baseline and week 52. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis). At weeks 4 and 52, 53.8% of patients achieved treatment success, which was defined as an Investigator Global Assessment of 0/1 with a ≥ 2-grade improvement from baseline. The mean affected BSA decreased from 58.0% at baseline to 11.4% at week 4 and continued to decrease to 2.2% through week 52. “I was surprised that patients could maintain control over the long-term using the medication as needed,” Dr. Stein Gold told this news organization. “I was also pleased to see that there was low systemic exposure even when used on large body surface areas.”

In other findings, the mean total Patient Oriented Eczema Measure score dropped from a baseline of 19.4 to a mean of 4.5 at week 8 and 3.6 at week 52 and the mean total Children’s Dermatology Life Quality Index score fell from a baseline of 15.4 to a mean of 5.3 at week 8 and a mean of 2.1 at week 52. Meanwhile, the mean total Infants’ Dermatology Quality of Life Index score fell from a mean of 12.3 at baseline to a mean of 2.8 at week 8 and a mean of 0.7 at week 52.

Dr. Stein Gold noted certain limitations of the study, including the fact that it did not study children aged younger than 2 years.

The study was funded by Incyte, which markets ruxolitinib cream 1.5% as Opzelura. Dr. Stein Gold disclosed that she has served as an investigator, advisor, and/or speaker for several pharmaceutical companies, including Incyte.

A version of this article appeared on Medscape.com.

Treatment with topical ruxolitinib cream 1.5% showed good tolerability and was effective over the course of 52 weeks in children aged 2-11 years with atopic dermatitis (AD) affecting ≥ 35% or more of their body surface area (BSA), results from a small open-label maximum-use trial showed.

When approved for this age group, ruxolitinib cream will provide a topical nonsteroidal option for patients aged 2-11, which will “simplify the treatment regimen,” one of the study investigators, Linda Stein Gold, MD, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit, said in an interview after the Revolutionizing Atopic Dermatitis conference, where the study was presented during a late-breaking abstract session.

Dr. Linda Stein Gold, director of clinical research and division head of dermatology at the Henry Ford Health System, Detroit.
Dr. Stein Gold
Dr. Linda Stein Gold

A topical formulation of the selective Janus kinase (JAK) 1/JAK2 inhibitor, ruxolitinib cream 1.5% is currently approved by the Food and Drug Administration for the short-term and noncontinuous chronic treatment of mild to moderate AD in non-immunocompromised adult and pediatric patients aged 12 years and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

In previous reports of this trial in children aged 2-11 years with ≥ 35% affected BSA, ruxolitinib cream 1.5% was generally well tolerated, with rapid anti-inflammatory and antipruritic effects and improvements in patient-reported outcomes observed with ≤ 4 weeks of continuous treatment and maintained with as-needed treatment from 4 to 8 weeks.

For the current trial, investigators evaluated data on tolerability, safety, systemic exposure, and clinical and patient-reported outcomes through 52 weeks to determine whether clinical benefits and tolerability observed through 8 weeks were sustained.

Dr. Stein Gold and colleagues reported results from 29 children who received ruxolitinib cream 1.5% from baseline through week 8. Of these, 22 continued into the long-term safety period from week 8 through 52. From baseline through week 8, patients applied a mean of 6.5 g per day of ruxolitinib cream; this dropped to a mean of 3.2 g per day from weeks 8 through 52. The mean steady-state plasma concentration of ruxolitinib throughout the study was 98.2 nM, which is “well below half-maximal concentration of JAK-mediated myelosuppression in adults (281 nM),” the researchers stated in their abstract.



No treatment-related interruptions, discontinuations, or serious adverse events were observed between baseline and week 52. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis). At weeks 4 and 52, 53.8% of patients achieved treatment success, which was defined as an Investigator Global Assessment of 0/1 with a ≥ 2-grade improvement from baseline. The mean affected BSA decreased from 58.0% at baseline to 11.4% at week 4 and continued to decrease to 2.2% through week 52. “I was surprised that patients could maintain control over the long-term using the medication as needed,” Dr. Stein Gold told this news organization. “I was also pleased to see that there was low systemic exposure even when used on large body surface areas.”

In other findings, the mean total Patient Oriented Eczema Measure score dropped from a baseline of 19.4 to a mean of 4.5 at week 8 and 3.6 at week 52 and the mean total Children’s Dermatology Life Quality Index score fell from a baseline of 15.4 to a mean of 5.3 at week 8 and a mean of 2.1 at week 52. Meanwhile, the mean total Infants’ Dermatology Quality of Life Index score fell from a mean of 12.3 at baseline to a mean of 2.8 at week 8 and a mean of 0.7 at week 52.

Dr. Stein Gold noted certain limitations of the study, including the fact that it did not study children aged younger than 2 years.

The study was funded by Incyte, which markets ruxolitinib cream 1.5% as Opzelura. Dr. Stein Gold disclosed that she has served as an investigator, advisor, and/or speaker for several pharmaceutical companies, including Incyte.

A version of this article appeared on Medscape.com.

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Pediatric Atopic Dermatitis: Study Suggests Treatment May Impact Atopic March

Article Type
Changed
Fri, 06/21/2024 - 16:44

 

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
  • Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
  • Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

  • Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
  • The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
  • Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
  • However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

 

 

A version of this article appeared on Medscape.com .

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TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
  • Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
  • Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

  • Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
  • The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
  • Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
  • However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

 

 

A version of this article appeared on Medscape.com .

 

TOPLINE:

Pediatric patients with atopic dermatitis (AD) who are prescribed dupilumab may be at a reduced risk for atopic march progression, defined as the development of asthma or allergic rhinitis.

METHODOLOGY:

  • Researchers conducted a retrospective cohort study using data from the US Collaborative Network, focusing on pediatric patients aged 18 years and younger with two AD diagnoses at least 30 days apart.
  • Patients were divided into two cohorts: Those treated with dupilumab (n = 2192) and those who received conventional therapies (n = 2192), including systemic corticosteroids or conventional immunomodulators. They were stratified into three age groups: Preschoolers (< 6 years), school-aged children (6 to < 12 years), and adolescents (12-18 years).
  • Both cohorts underwent 1:1 propensity score matching based on current age, age at index (first prescription of dupilumab or conventional therapy), sex, race, comorbidities, laboratory measurements, and prior medications. The primary outcome was atopic march progression, defined by incident asthma or allergic rhinitis.

TAKEAWAY:

  • Over 3 years, the dupilumab-treated cohort had a significantly lower cumulative incidence of atopic march progression (20.09% vs 27.22%; P < .001), asthma (9.43% vs 14.64%; = .001), and allergic rhinitis (13.57% vs 20.52%; P = .003) than the conventional therapy cohort.
  • The risk for atopic march progression, asthma, and allergic rhinitis was also significantly reduced by 32%, 40%, and 31%, respectively, in the dupilumab vs conventional therapy cohort.
  • Age-specific analyses found that the protective effect of dupilumab against allergic rhinitis was the most pronounced in adolescents (hazard ratio [HR], 0.503; 95% CI, 0.322-0.784), followed by school-aged children (HR, 0.577; 95% CI, 0.399-0.834), and preschoolers (HR, 0.623; 95% CI, 0.412-0.942).
  • However, dupilumab was associated with reduced risk for asthma only in preschoolers (HR, 0.427; 95% CI, 0.247-0.738) and not in school-aged children or adolescents.

IN PRACTICE:

“Dupilumab in AD not only treats the disease but may influence atopic march mechanisms, suggesting its role as a disease-modifying atopic march drug,” the authors wrote, adding that more research “with extended follow-up and proof-of-concept is warranted.”

SOURCE:

The study was led by Teng-Li Lin, MD, Department of Dermatology, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan, and was published online on June 13, 2024, in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The observational nature of the study limited the ability to infer direct causality between dupilumab use and reduced atopic march risk. Lack of detailed information on AD severity, total dosage, and duration of medication treatment may affect the interpretation of the study’s findings. The demographic data suggest that the dupilumab cohort had more severe AD, so the observed risk reduction may be greater than that reported in this study.

DISCLOSURES:

The study was supported in part by the National Science and Technology Council, Taiwan, and Taichung Veterans General Hospital. The authors had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

 

 

A version of this article appeared on Medscape.com .

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High Sodium Intake Linked to Greater Risk for Eczema

Article Type
Changed
Fri, 06/07/2024 - 13:04

In a study of adults, an increase of 1 g in estimated 24-hour urinary sodium excretion was associated with 11% higher odds of an atopic dermatitis (AD) diagnosis, 16% higher odds of having active AD, and 11% higher odds of increased severity of AD.

Those are key findings from a cross-sectional analysis of data from the United Kingdom.

“Excessive dietary sodium, common in fast food, may be associated with AD,” corresponding author Katrina Abuabara, MD, MA, MSCE, and colleagues wrote in the study, which was published online in JAMA Dermatology. They referred to recent research using sodium MRI, which showed that “the majority of the body’s exchangeable sodium is stored in the skin and that skin sodium is associated with autoimmune and chronic inflammatory conditions, including AD.” And in another study published in 2019, lesional skin sodium was 30-fold greater in patients with AD than in healthy controls.

To investigate whether there is an association between higher levels of sodium consumption and AD prevalence, activity, and severity at the population level, Dr. Abuabara, of the program for clinical research in the Department of Dermatology at the University of California, San Francisco, and coauthors drew from the UK Biobank, a population-based cohort of more than 500,000 individuals aged 37-73 years at the time of recruitment by the National Health Service. The primary exposure was 24-hour urinary sodium excretion, which was calculated by using the INTERSALT equation, a sex-specific estimation that incorporates body mass index; age; and urine concentrations of potassium, sodium, and creatinine. The primary study outcome was AD or active AD based on diagnostic and prescription codes from linked electronic medical records. The researchers used multivariable logistic regression models adjusted for age, sex, race and ethnicity, Townsend deprivation index, and education to measure the association.

Of the 215,832 Biobank participants included in the analysis, 54% were female, their mean age was 57 years, 95% were White, their mean estimated 24-hour urine sodium excretion was 3.01 g/day, and 10,839 (5%) had a diagnosis of AD. The researchers observed that on multivariable logistic regression, a 1-g increase in estimated 24-hour urine sodium excretion was associated with increased odds of AD (adjusted odds ratio [AOR], 1.11; 95% CI, 1.07-1.14), increased odds of active AD (AOR, 1.16; 95% CI, 1.05-1.28), and increased odds of increasing severity of AD (AOR, 1.11; 95% CI, 1.07-1.15).
 

Validating Results With US Data

To validate the findings, the researchers evaluated a cohort of 13,014 participants from the US-based National Health and Nutrition Examination Survey (NHANES), using pooled data from the 1999-2000, 2001-2002, and 2003-2004 samples. Of the 13,014 participants, 796 reported current AD, and 1493 reported AD in the past year. The mean dietary sodium intake of overall NHANES participants estimated with 24-hour dietary recall questionnaires was 3.45 g, with a mean of 3.47 g for those with current AD and a mean of 3.44 g for those without AD.

The researchers observed that a 1-g/day higher dietary sodium intake was associated with a higher risk for current AD (AOR, 1.22; 95%CI, 1.01-1.47) and a somewhat higher risk for AD in the past year (AOR, 1.14; 95% CI, 0.97-1.35).

“Future work should examine whether variation of sodium intake over time might trigger AD flares and whether it helps to explain heterogeneity in response to new immunomodulatory treatments for AD,” the authors wrote. “Reduced sodium intake was recommended as a treatment for AD more than a century ago, but there have yet to be studies examining the association of dietary sodium reduction with skin sodium concentration or AD severity,” they added. Noting that sodium reduction “has been shown to be a cost-effective intervention for hypertension and other cardiovascular disease outcomes,” they said that their data “support experimental studies of this approach in AD.”

They acknowledged certain limitations of the study, including the fact that a single spot urine sample was used in the UK Biobank cohort, “which only captures dietary intake of the last 24 hours and is not the best measure of usual or long-term intake of sodium.” They also noted that the findings may not be generalizable to other populations and that AD was based on self-report in the NHANES validation cohort.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the results, said the study by Dr. Abuabara and colleagues “gives us another reason to avoid salt, showing that 1 g/day of higher salt intake increases the risk of AD in an adult population and more severe AD.”

He added that, “Now, can you say that reducing salt intake will have a therapeutic effect or clinically relevant impact? No. [That is] certainly worth exploring but at a minimum, gives some more credibility to keeping it bland.”

The study was supported by a grant from the Medical Student in Aging Research Program, the National Institute on Aging, and the National Eczema Association. Dr. Abuabara reported receiving research funding for her institution from Pfizer and Cosmetique Internacional/La Roche-Posay and consulting fees from Target RWE, Sanofi, Nektar, and Amgen. No other disclosures were reported. Dr. Friedman had no relevant disclosures.

A version of this article appeared on Medscape.com.

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In a study of adults, an increase of 1 g in estimated 24-hour urinary sodium excretion was associated with 11% higher odds of an atopic dermatitis (AD) diagnosis, 16% higher odds of having active AD, and 11% higher odds of increased severity of AD.

Those are key findings from a cross-sectional analysis of data from the United Kingdom.

“Excessive dietary sodium, common in fast food, may be associated with AD,” corresponding author Katrina Abuabara, MD, MA, MSCE, and colleagues wrote in the study, which was published online in JAMA Dermatology. They referred to recent research using sodium MRI, which showed that “the majority of the body’s exchangeable sodium is stored in the skin and that skin sodium is associated with autoimmune and chronic inflammatory conditions, including AD.” And in another study published in 2019, lesional skin sodium was 30-fold greater in patients with AD than in healthy controls.

To investigate whether there is an association between higher levels of sodium consumption and AD prevalence, activity, and severity at the population level, Dr. Abuabara, of the program for clinical research in the Department of Dermatology at the University of California, San Francisco, and coauthors drew from the UK Biobank, a population-based cohort of more than 500,000 individuals aged 37-73 years at the time of recruitment by the National Health Service. The primary exposure was 24-hour urinary sodium excretion, which was calculated by using the INTERSALT equation, a sex-specific estimation that incorporates body mass index; age; and urine concentrations of potassium, sodium, and creatinine. The primary study outcome was AD or active AD based on diagnostic and prescription codes from linked electronic medical records. The researchers used multivariable logistic regression models adjusted for age, sex, race and ethnicity, Townsend deprivation index, and education to measure the association.

Of the 215,832 Biobank participants included in the analysis, 54% were female, their mean age was 57 years, 95% were White, their mean estimated 24-hour urine sodium excretion was 3.01 g/day, and 10,839 (5%) had a diagnosis of AD. The researchers observed that on multivariable logistic regression, a 1-g increase in estimated 24-hour urine sodium excretion was associated with increased odds of AD (adjusted odds ratio [AOR], 1.11; 95% CI, 1.07-1.14), increased odds of active AD (AOR, 1.16; 95% CI, 1.05-1.28), and increased odds of increasing severity of AD (AOR, 1.11; 95% CI, 1.07-1.15).
 

Validating Results With US Data

To validate the findings, the researchers evaluated a cohort of 13,014 participants from the US-based National Health and Nutrition Examination Survey (NHANES), using pooled data from the 1999-2000, 2001-2002, and 2003-2004 samples. Of the 13,014 participants, 796 reported current AD, and 1493 reported AD in the past year. The mean dietary sodium intake of overall NHANES participants estimated with 24-hour dietary recall questionnaires was 3.45 g, with a mean of 3.47 g for those with current AD and a mean of 3.44 g for those without AD.

The researchers observed that a 1-g/day higher dietary sodium intake was associated with a higher risk for current AD (AOR, 1.22; 95%CI, 1.01-1.47) and a somewhat higher risk for AD in the past year (AOR, 1.14; 95% CI, 0.97-1.35).

“Future work should examine whether variation of sodium intake over time might trigger AD flares and whether it helps to explain heterogeneity in response to new immunomodulatory treatments for AD,” the authors wrote. “Reduced sodium intake was recommended as a treatment for AD more than a century ago, but there have yet to be studies examining the association of dietary sodium reduction with skin sodium concentration or AD severity,” they added. Noting that sodium reduction “has been shown to be a cost-effective intervention for hypertension and other cardiovascular disease outcomes,” they said that their data “support experimental studies of this approach in AD.”

They acknowledged certain limitations of the study, including the fact that a single spot urine sample was used in the UK Biobank cohort, “which only captures dietary intake of the last 24 hours and is not the best measure of usual or long-term intake of sodium.” They also noted that the findings may not be generalizable to other populations and that AD was based on self-report in the NHANES validation cohort.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the results, said the study by Dr. Abuabara and colleagues “gives us another reason to avoid salt, showing that 1 g/day of higher salt intake increases the risk of AD in an adult population and more severe AD.”

He added that, “Now, can you say that reducing salt intake will have a therapeutic effect or clinically relevant impact? No. [That is] certainly worth exploring but at a minimum, gives some more credibility to keeping it bland.”

The study was supported by a grant from the Medical Student in Aging Research Program, the National Institute on Aging, and the National Eczema Association. Dr. Abuabara reported receiving research funding for her institution from Pfizer and Cosmetique Internacional/La Roche-Posay and consulting fees from Target RWE, Sanofi, Nektar, and Amgen. No other disclosures were reported. Dr. Friedman had no relevant disclosures.

A version of this article appeared on Medscape.com.

In a study of adults, an increase of 1 g in estimated 24-hour urinary sodium excretion was associated with 11% higher odds of an atopic dermatitis (AD) diagnosis, 16% higher odds of having active AD, and 11% higher odds of increased severity of AD.

Those are key findings from a cross-sectional analysis of data from the United Kingdom.

“Excessive dietary sodium, common in fast food, may be associated with AD,” corresponding author Katrina Abuabara, MD, MA, MSCE, and colleagues wrote in the study, which was published online in JAMA Dermatology. They referred to recent research using sodium MRI, which showed that “the majority of the body’s exchangeable sodium is stored in the skin and that skin sodium is associated with autoimmune and chronic inflammatory conditions, including AD.” And in another study published in 2019, lesional skin sodium was 30-fold greater in patients with AD than in healthy controls.

To investigate whether there is an association between higher levels of sodium consumption and AD prevalence, activity, and severity at the population level, Dr. Abuabara, of the program for clinical research in the Department of Dermatology at the University of California, San Francisco, and coauthors drew from the UK Biobank, a population-based cohort of more than 500,000 individuals aged 37-73 years at the time of recruitment by the National Health Service. The primary exposure was 24-hour urinary sodium excretion, which was calculated by using the INTERSALT equation, a sex-specific estimation that incorporates body mass index; age; and urine concentrations of potassium, sodium, and creatinine. The primary study outcome was AD or active AD based on diagnostic and prescription codes from linked electronic medical records. The researchers used multivariable logistic regression models adjusted for age, sex, race and ethnicity, Townsend deprivation index, and education to measure the association.

Of the 215,832 Biobank participants included in the analysis, 54% were female, their mean age was 57 years, 95% were White, their mean estimated 24-hour urine sodium excretion was 3.01 g/day, and 10,839 (5%) had a diagnosis of AD. The researchers observed that on multivariable logistic regression, a 1-g increase in estimated 24-hour urine sodium excretion was associated with increased odds of AD (adjusted odds ratio [AOR], 1.11; 95% CI, 1.07-1.14), increased odds of active AD (AOR, 1.16; 95% CI, 1.05-1.28), and increased odds of increasing severity of AD (AOR, 1.11; 95% CI, 1.07-1.15).
 

Validating Results With US Data

To validate the findings, the researchers evaluated a cohort of 13,014 participants from the US-based National Health and Nutrition Examination Survey (NHANES), using pooled data from the 1999-2000, 2001-2002, and 2003-2004 samples. Of the 13,014 participants, 796 reported current AD, and 1493 reported AD in the past year. The mean dietary sodium intake of overall NHANES participants estimated with 24-hour dietary recall questionnaires was 3.45 g, with a mean of 3.47 g for those with current AD and a mean of 3.44 g for those without AD.

The researchers observed that a 1-g/day higher dietary sodium intake was associated with a higher risk for current AD (AOR, 1.22; 95%CI, 1.01-1.47) and a somewhat higher risk for AD in the past year (AOR, 1.14; 95% CI, 0.97-1.35).

“Future work should examine whether variation of sodium intake over time might trigger AD flares and whether it helps to explain heterogeneity in response to new immunomodulatory treatments for AD,” the authors wrote. “Reduced sodium intake was recommended as a treatment for AD more than a century ago, but there have yet to be studies examining the association of dietary sodium reduction with skin sodium concentration or AD severity,” they added. Noting that sodium reduction “has been shown to be a cost-effective intervention for hypertension and other cardiovascular disease outcomes,” they said that their data “support experimental studies of this approach in AD.”

They acknowledged certain limitations of the study, including the fact that a single spot urine sample was used in the UK Biobank cohort, “which only captures dietary intake of the last 24 hours and is not the best measure of usual or long-term intake of sodium.” They also noted that the findings may not be generalizable to other populations and that AD was based on self-report in the NHANES validation cohort.

Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the results, said the study by Dr. Abuabara and colleagues “gives us another reason to avoid salt, showing that 1 g/day of higher salt intake increases the risk of AD in an adult population and more severe AD.”

He added that, “Now, can you say that reducing salt intake will have a therapeutic effect or clinically relevant impact? No. [That is] certainly worth exploring but at a minimum, gives some more credibility to keeping it bland.”

The study was supported by a grant from the Medical Student in Aging Research Program, the National Institute on Aging, and the National Eczema Association. Dr. Abuabara reported receiving research funding for her institution from Pfizer and Cosmetique Internacional/La Roche-Posay and consulting fees from Target RWE, Sanofi, Nektar, and Amgen. No other disclosures were reported. Dr. Friedman had no relevant disclosures.

A version of this article appeared on Medscape.com.

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