In a recent Phase 3 trial, stapokibart demonstrated long-term efficacy and a favorable safety profile in adult patients with moderate-to-severe atopic dermatitis (AD). The study, led by Yan Zhao from Peking University People's Hospital in China, highlights the potential of stapokibart as a continuous, long-term treatment option for this chronic skin condition.
The 52-week results, published in Allergy, showed that improvements in AD signs and symptoms observed during the initial 16 weeks of stapokibart treatment were maintained or continued to improve. This is particularly significant given the limitations of current long-term treatments, such as topical corticosteroids, which can lead to adverse events with prolonged use.
The trial, conducted across 59 hospitals in China, included patients who had participated in a previous 16-week double-blind, placebo-controlled study. In that initial study, a significantly greater proportion of patients on stapokibart achieved at least a 75% improvement from baseline in their Eczema Area and Severity Index (EASI) score compared to placebo (66.9% vs 25.8%; P < .001). Additionally, more patients on stapokibart achieved an Investigator’s Global Assessment (IGA) score of 0 or 1 with at least a 2-point reduction (44.2% vs 16.1%; P < .0001).
Following the initial 16 weeks, patients in both the stapokibart and placebo arms entered a 36-week maintenance period, receiving stapokibart 300 mg every two weeks. Patients were allowed to use topical medications for AD during this period, in addition to twice-daily moisturizer applications. Of the 476 patients who entered the maintenance period, 430 completed the treatment.
Sustained Efficacy at 52 Weeks
At week 52, 92.5% of patients who continued on stapokibart and 88.7% of patients who switched from placebo to stapokibart achieved a 75% improvement in EASI score. Furthermore, 67.3% of the continuing stapokibart group and 60.5% of the switch group achieved at least a 4-point reduction in the weekly average of the daily Peak Pruritus Numerical Rating Scale.
Safety Profile
The majority (88.1%) of patients reported treatment-emergent adverse events, but most were mild or moderate. The most common infections and infestations reported were COVID-19 (38.9%), upper respiratory tract infection (14.7%), and suspected COVID-19 (11.5%). Conjunctivitis was observed in 5.3% of patients, and injection site reactions occurred in 2% of patients.
Implications for Atopic Dermatitis Treatment
The investigators concluded that stapokibart 300 mg every two weeks demonstrated sustained efficacy in Chinese adults with moderate-to-severe atopic dermatitis for up to 52 weeks, with a favorable safety profile. These data support the potential of stapokibart as a continuous, long-term treatment for adults with this condition. The study addresses the need for long-term medications for atopic dermatitis, as current options like corticosteroids and phototherapy have limitations and potential risks.
