Stapokibart's clinical effectiveness in treating moderate-to-severe bullous pemphigoid in the elderly

Bullous pemphigoid (BP) is the most common autoimmune blistering disease in the elderly, for whom conventional systemic corticosteroids and immunosuppressants pose significant safety risks due to age-related comorbidities, leading to infections, osteoporosis, and metabolic disorders. While stapokibart, a novel IL-4Rα inhibitor, holds promise for type 2 inflammatory diseases, clinical evidence regarding its efficacy in BP is currently lacking. Therefore, this study aims to observe the clinical efficacy and long-term safety of stapokibart in the treatment of moderate-to-severe BP in the elderly.

This single-center, retrospective, uncontrolled case series included 15 elderly patients with moderate-to-severe BP. In addition to conventional topical glucocorticoids or combined systemic therapy, patients received an initial dose of 600 mg stapokibart, followed by 300 mg every 2 weeks. Dosage adjustments were made based on patients' clinical responses after 16 weeks. The core treatment period was 24 weeks, with a subsequent post-treatment follow-up duration ranging from 4 to 34 weeks (mean 18.78 ± 11.54 weeks). The primary outcome was explicitly defined as the achievement of disease control at 4 weeks. Secondary outcomes included the BP disease area index (BPDAI), dermatology life quality index (DLQI), itch numerical rating scale (NRS), absolute eosinophil count (EO), anti-BP180 antibody levels, relapse rate, and safety profiles, which were assessed at baseline and weeks 2, 4, 8, 16, and 24.

The primary outcome of disease control was achieved in 100.00% (15/15) of the patients within 4 weeks, with a mean time to control of 10.18 ± 3.06 days. Secondary outcomes including BPDAI, DLQI, itch NRS scores, EOs, and anti-BP180 antibody levels were all significantly reduced at week 24 compared to baseline (all P < 0.05). During the study and a subsequent mean follow-up duration of 18.78 ± 11.54 weeks, the disease recurrence rate was 26.67% (4/15). Regarding safety, injection site reactions occurred in 13.3% (2/15) of the patients, these were mild and self-limiting, with no patients discontinuing treatment due to adverse events.

Stapokibart may serve as an effective and well-tolerated adjunctive option for alleviating skin lesions and pruritus in elderly patients with moderate-to-severe BP. However, given the small sample size and uncontrolled retrospective design, larger, prospective randomized controlled trials are required to definitively confirm its long-term efficacy and safety.