Low Occurrence of Predefined Safety Events Across Six Randomized Clinical Trials of Spesolimab in Dermatologic Conditions

Kenneth B Gordon, K. Eyerich, Milan J Anadkat, S. Choon, Boni Elewski, Jonathan N. Barker, Arash Mostaghimi, Ming Tang, T. Haeufel, C. Thoma, Diamant Thaçi
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Abstract

Introduction In the randomized, placebo-controlled Effisayil 2 trial, the anti-interleukin (IL)-36 receptor antibody spesolimab demonstrated a reassuring safety profile when given over 48 weeks for flare prevention in patients with generalized pustular psoriasis (GPP). Nevertheless, given its novel mechanistic approach, it is important to characterize events relating to IL-36 inhibition with spesolimab as well as those of potential relevance to an intravenously/subcutaneously administered biologic. Methods In this analysis, rates of such predefined events – severe/serious/opportunistic infections, potential hypersensitivity reactions, peripheral neuropathies, and malignant tumors – were examined using available data from six randomized trials of spesolimab across various dermatologic conditions. Results Events reported in patients receiving spesolimab at various doses and schedules in two trials in GPP, two in palmoplantar pustulosis (PPP), one in atopic dermatitis (AD), and one in hidradenitis suppurativa (HS) were included (total n=345 for spesolimab and 145 for placebo). Exposure to spesolimab was: GPP, 244.3; PPP, 327.8; AD, 40.0; and HS, 45.7 patient-years, respectively. Rates of severe/serious/opportunistic infections were low with spesolimab (3.2% in one GPP trial; otherwise, 0% vs. 0% with placebo), and the incidences of hypersensitivity reactions were similar for spesolimab (7.7–33.3%) and placebo (5.6–44.4%) across trials. There was one report of peripheral neuropathy with spesolimab in a PPP trial (incidence 0–0.9% across trials) versus two (one GPP, one PPP) with placebo (0–3.3%), and one malignancy with spesolimab in GPP (0–1.1% across trials) versus one with placebo in PPP (0–2.3%). Conclusion These results support the favorable safety profile of spesolimab seen in Effisayil 2.
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斯派索利单抗治疗皮肤病的六项随机临床试验中预定义安全事件发生率较低
导言:在随机安慰剂对照的Effisayil 2试验中,抗白细胞介素(IL)-36受体抗体spesolimab用于预防泛发性脓疱型银屑病(GPP)患者复发,用药48周后显示出令人放心的安全性。尽管如此,由于斯派索利单抗采用了新颖的机理方法,因此对与斯派索利单抗抑制IL-36相关的事件以及与静脉注射/皮下注射生物制剂可能相关的事件进行描述非常重要。方法 在这项分析中,我们利用斯派索利单抗的六项随机试验中涉及各种皮肤病的现有数据,研究了这些预定义事件的发生率--严重/严重/机会性感染、潜在超敏反应、周围神经病和恶性肿瘤。结果 纳入了两项GPP试验、两项掌跖脓疱病(PPP)试验、一项特应性皮炎(AD)试验和一项化脓性扁桃体炎(HS)试验中以不同剂量和疗程接受斯来索利单抗治疗的患者所发生的事件(斯来索利单抗的总人数=345,安慰剂的总人数=145)。斯派索利单抗的暴露量为GPP为244.3人年;PPP为327.8人年;AD为40.0人年;HS为45.7人年。斯派索利单抗的严重/严重/机会性感染率较低(一项GPP试验中为3.2%;其他试验中为0%,安慰剂为0%),各试验中斯派索利单抗(7.7-33.3%)和安慰剂(5.6-44.4%)的超敏反应发生率相似。在一项PPP试验中,斯派索利单抗有1例外周神经病变报告(各试验发生率为0-0.9%),而安慰剂有2例(1例GPP,1例PPP)(0-3.3%);在GPP试验中,斯派索利单抗有1例恶性肿瘤报告(各试验发生率为0-1.1%),而安慰剂有1例恶性肿瘤报告(0-2.3%)。结论 这些结果支持了在 Effisayil 2 中观察到的斯派索利单抗良好的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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