Long‐term efficacy and safety of stapokibart for moderate‐to‐severe atopic dermatitis: 52‐week results from a phase 3 trial

Abstract Background Management of moderate‐to‐severe atopic dermatitis (AD) needs long‐term therapy. Stapokibart is a humanized monoclonal antibody targeting interleukin‐4 receptor α subunit (IL‐4Rα), a shared receptor for IL‐4 and IL‐13 which are key pathogenic drivers of AD. In a pivotal phase 3 trial (NCT05265923), significant higher proportions of adult AD patients receiving stapokibart than placebo achieved ≥75% improvement from baseline in Eczema Area and Severity Index (EASI‐75; 66.9% vs. 25.8%) and Investigator's Global Assessment (IGA) score of 0/1 with ≥2‐point reduction (44.2% vs. 16.1%) at Week 16. Herein, we report long‐term (52 weeks) efficacy and safety of stapokibart from this trial. Methods After 16‐week double‐blind treatment completed, patients in both stapokibart and placebo groups entered a 36‐week maintenance treatment period and received stapokibart 300 mg every 2 weeks. Concomitant use of topical medications for AD was permitted throughout the maintenance period. Results Of 476 patients entering maintenance period, 430 completed the treatment. At Week 52, EASI‐75 was achieved in 92.5% of patients continuing stapokibart and 88.7% of those switching from placebo to stapokibart, respectively; an IGA score of 0 or 1 with a ≥2‐point reduction was achieved in 67.3% and 64.2% of patients, respectively; a ≥4‐point reduction in weekly average of daily Peak Pruritus Numerical Rating Scale (PP‐NRS) was achieved in 67.3% and 60.5% of patients, respectively. Over the 52‐week treatment period, 88.1% of patients reported treatment‐emergent adverse events, most were mild or moderate. Conclusion Long‐term treatment with stapokibart demonstrated a sustained efficacy and favorable safety profile in adults with moderate‐to‐severe AD.