Trial reportInternational journal of dermatology2026
Efficacy and Safety of Anti-IL-4Rα Stapokibart in Elderly Patients With Moderate-To-Severe Atopic Dermatitis.
Trial report in International journal of dermatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundElderly patients with moderate-to-severe atopic dermatitis (AD) often exhibit more heterogeneous inflammatory profiles compared with younger adults. To evaluate the efficacy and safety of stapokibart, an anti-interleukin-4 receptor α subunit (IL-4Rα) monoclonal antibody, in different age subgroups.
methodsEligible adults were randomized to receive subcutaneous stapokibart 300 mg every 2 weeks (Q2W; loading dose 600 mg) or placebo for 16 weeks. All patients subsequently received stapokibart 300 mg Q2W for 36 weeks. In this post hoc analysis, patients were classified as elderly (aged ≥ 60 years, n = 93) and non-elderly patients (aged 18 and < 60 years, n = 407). Main efficacy outcomes included ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI-75), Investigator's Global Assessment (IGA) 0/1, and ≥ 4-point reduction in weekly average of daily peak pruritus Numerical Rating Scale (PP-NRS) score.
resultsIn elderly patients at Week 16, response rates for stapokibart versus placebo were 56.0% vs. 14.0% for EASI-75 (p < 0.0001), 40.0% vs. 7.0% for IGA 0/1 (p = 0.0003), and 32.0% vs. 7.0% for ≥ 4-point reduction in weekly average of daily PP-NRS (p = 0.0023). In non-elderly patients, corresponding response rates were 69.7% vs. 28.3%, 45.3% vs. 18.0%, and 36.8% vs. 12.7%, respectively (all p < 0.0001). Within both age subgroups, progressive improvements across all efficacy measures were observed during the maintenance treatment period. The incidence of treatment-emergent adverse events was similar between stapokibart and placebo groups during the 16-week treatment period, regardless of age.
conclusionStapokibart was effective and had a favorable safety profile in elderly patients with moderate-to-severe AD.
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