Dupilumab Effects Similar in Older and Younger Patients With Atopic Dermatitis

In patients aged 60 years and older with moderate to severe atopic dermatitis (AD), dupilumab is associated with significant improvements, similar to effects observed among younger patients. These study findings were published in the American Journal of Clinical Dermatology.

Researchers sourced data from 4 randomized, placebo-controlled trials, LIBERTY AD SOLO 1 (ClinicalTrials.gov Identifier: NCT02277743), LIBERTY AD SOLO 2 (ClinicalTrials.gov Identifier: NCT02277769), LIBERTY AD CAFÉ (ClinicalTrials.gov Identifier: NCT02755649), and LIBERTY AD CHRONOS (ClinicalTrials.gov Identifier: NCT02260986).

Participants were randomly assigned in a 1:1:1 fashion to receive subcutaneous dupilumab 300 mg every week or every 2 weeks, or placebo with or without concomitant topical corticosteroids. The study populations were pooled, and outcomes were compared between patients aged 60 years (n=183) and older with those aged younger than 60 years (n=2261). The primary efficacy outcomes were an Investigator’s Global Assessment (IGA) score of 0 or 1 with an at least 2-point improvement from baseline and a 75% improvement in Eczema Area and Severity Index (EASI-75).

The older and younger cohorts comprised 59.6% and 59.0% men, had a median age of 65.0 (IQR, 62.0-69.0) and 35.0 (IQR, 25.0-45.0) years, 92.9% and 69.5% were White, respectively. Overall mean AD duration was 45.0 (IQR, 11.0-61.0) and 26.0 (IQR, 18.0-38.0) years, 54.6% and 47.2% of participants had an IGA score of 4 points at baseline, and median EASI score at baseline was 29.4 (IQR, 22.0-40.4) and 30.0 (IQR, 22.2-41.0) points, respectively.

Among the older cohort, 73, 54, and 56 participants were in the weekly, every 2 weeks, and placebo groups, respectively. Among the younger cohort 818, 616, and 827 were in the weekly, every 2 weeks, and placebo groups, respectively.

The primary IGA outcome was achieved by 39.7% (P <.0001) and 44.4% (P <.0001) of those in the dupilumab weekly and every 2 weeks groups compared with 7.1% of the placebo group, respectively. The EASI-75 outcome was achieved by 61.6% (P <.0001) and 63.0% (P <.0001) compared with 14.3%, respectively.

These rates were similar to the rate of IGA (39.7% and 37.8% vs 12.1%; both P <.0001) and EASI-75 (60.4% and 55.2% vs 22.1%; both P <.0001) outcome achievement among the younger cohorts of participants in the weekly and every 2 weeks groups compared with those in the placebo group, respectively.

As with efficacy, safety signals were consistent among the older and younger groups. The rates of severe treatment-emergent adverse events were 9.44 per 100 person-years for weekly dupilumab, 112.54 per 100 person-years for dupilumab every 2 weeks, and 40.09 per 100 person-years for placebo treatments among patients aged 60 years and older. The most common events among older dupilumab recipients were AD and injection-site reactions.

Limitations of the study include the small sample sizes in the older cohorts and of the use of pooled data from multiple independent trials.

Study authors conclude, “Dupilumab, with or without [topical corticosteroids], improves AD signs and symptoms with an acceptable safety profile in patients [60 years and younger] with moderate-to-severe AD. Dupilumab efficacy and safety profiles in patients [60 years and younger] are also generally consistent with those in patients [older than 60 years].”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.