Efficacy and Safety of Extending Dosing Interval of Stapokibart in Patients with Atopic Dermatitis

Abstract: Background: Stapokibart is a novel anti-interleukin-4 receptor α subunit monoclonal antibody approved for moderate-to-severe atopic dermatitis (AD) in adults. Objective: To evaluate the feasibility of extending dosing interval of stapokibart based on efficacy response in AD. Methods: In this ongoing, multicenter, open-label, single-arm trial (NCT06116565), stapokibart 300 mg was administered subcutaneously every 2 weeks (Q2W) for 12 weeks, followed by dosing interval adjustments at weeks 12 and 36. At week 12, nonresponders (failed to achieve ≥50% improvement from baseline in Eczema Area and Severity Index [EASI-50]) were withdrawn, fast responders (achieved ≥75% improvement from baseline in EASI score [EASI-75] or Investigator’s Global Assessment score of 0/1 [IGA 0/1]) were extended to every 4 weeks (Q4W), and slow responders (achieved EASI-50 but not EASI-75 or IGA 0/1) continued Q2W dosing. At week 36, fast responders achieving ≥90% improvement from baseline in EASI score (EASI-90) or IGA 0/1 were further extended to every 8 weeks (Q8W) (Q2W-Q4W-Q8W group), slow responders with EASI-90 or IGA 0/1 were extended to Q4W (Q2W-Q2W-Q4W group), and others maintained their prior dosing through week 52 (Q2W-Q4W-Q4W and Q2W-Q2W-Q2W groups). Results: As of April 7, 2025, 256 and 200 patients completed 12 and 36 weeks of treatment, respectively. In the Q2W-Q4W-Q8W group, 93.0%, 73.7%, and 70.7% of patients sustained EASI-75, IGA 0/1, and ≥4-point reduction in weekly average of daily Peak Pruritus Numerical Rating Scale at week 52, versus 99.2%, 90.1%, and 71.1% at week 36, and 98.3%, 54.5%, and 58.3% at week 12. These response rates in the Q2W-Q4W-Q4W group were 96.2%, 23.1%, and 38.5% at week 12, versus 81.8%, 63.6%, and 72.7% at week 52. In the Q2W-Q2W-Q4W group, these responses were achieved in 95.8%, 83.3%, and 77.3% of patients at week 36, increasing to 100%, 80.0%, and 80.0% at week 52. In the Q2W-Q2W-Q2W group, 84.6%, 23.1%, and 71.4% of patients progressively achieved these responses at week 52 with continued standard dosing. The overall incidence of treatment-emergent adverse events was 78.6%, mostly mild or moderate. Conclusion: Extending dosing interval of stapokibart based on efficacy response demonstrated sustained efficacy and favorable safety in AD.