Division of Dermatology, Department of Medicine, University of Toronto School of Medicine, Toronto, Ontario, Canada.
Mediprobe Research Inc., London, Ontario, Canada;
Skinmed. 2024 Aug 2;22(2):134-137. eCollection 2024.
Spevigo (spesolimab-sbzo) injection was recently approved for the treatment of generalized pustular psoriasis (GPP) in adults aged 18- 75 years. Spesolimab, a monoclonal antibody, binds to the interleukin-36 (IL-36) receptor and prevents its activation by IL-36 cytokines, leading to reduced inflammation, skin lesions, and flares. In a randomized placebo-controlled, phase 2 study (Effisayil-1, NCT03782792), 53 patients were randomized to spesolimab (n = 35) and placebo (n = 18) to evaluate the effect of a one-time 900-mg dose of spesolimab versus placebo against GPP flares. The primary endpoint was Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (no visible pustules) and the key secondary endpoint was the GPPGA total score of 0 or 1 (clear or almost clear skin) at the end of week 1. The primary endpoint was achieved by 54% (19/35) of patients in the spesolimab group and 6% (1/18) of patients in the placebo group. The key secondary endpoint was achieved by 43% (15/35) of patients in the spesolimab group and 11% (2/18) of patients in the placebo group. In the first week, adverse events (mild to severe) were reported in 66% (22/35) of patients in the spesolimab group and 56% (10/18) in the placebo group.
斯佩维索（spesolimab-sbzo）注射液最近被批准用于治疗 18-75 岁成人的泛发性脓疱性银屑病（GPP）。斯佩索利单抗是一种单克隆抗体，可与白细胞介素-36（IL-36）受体结合，并阻止其被 IL-36 细胞因子激活，从而减少炎症、皮肤损伤和发作。在一项随机、安慰剂对照、2 期研究（Effisayil-1，NCT03782792）中，53 名患者被随机分为斯佩索利单抗（n=35）和安慰剂（n=18）组，以评估单次 900mg 剂量的斯佩索利单抗与安慰剂相比对 GPP 发作的疗效。主要终点是全身性脓疱性银屑病医师全球评估（GPPGA）脓疱亚评分 0（无可见脓疱），关键次要终点是第 1 周末 GPPGA 总评分 0 或 1（皮肤清晰或几乎清晰）。主要终点在斯佩索利单抗组的 54%（19/35）患者和安慰剂组的 6%（1/18）患者中达到。关键次要终点在斯佩索利单抗组的 43%（15/35）患者和安慰剂组的 11%（2/18）患者中达到。在第 1 周，斯佩索利单抗组的 66%（22/35）患者和安慰剂组的 56%（10/18）患者报告了不良事件（轻度至重度）。
