Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial.

IF 5.4 2区医学 Q1 IMMUNOLOGY BioDrugs Pub Date : 2024-09-01 Epub Date: 2024-07-31 DOI:10.1007/s40259-024-00668-z

Yan Zhao, Jing-Yi Li, Bin Yang, Yang-Feng Ding, Li-Ming Wu, Li-Tao Zhang, Jin-Yan Wang, Qian-Jin Lu, Chun-Lei Zhang, Fu-Ren Zhang, Xiao-Hong Zhu, Yu-Mei Li, Xiao-Hua Tao, Qing-Chun Diao, Lin-Feng Li, Jian-Yun Lu, Xiao-Yong Man, Fu-Qiu Li, Xiu-Juan Xia, Jiao-Ran Song, Ying-Min Jia, Li-Bo Zhang, Bo Chen, Jian-Zhong Zhang

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Abstract

Background: Stapokibart/CM310, a humanized monoclonal antibody targeting the interleukin-4 receptor α chain, has shown promising treatment benefits in patients with moderate-to-severe atopic dermatitis in previous phase II clinical trials.

Objective: We aimed to evaluate the long-term efficacy and safety of stapokibart in adults with moderate-to-severe atopic dermatitis.

Methods: Enrolled patients who previously completed parent trials of stapokibart received a subcutaneous stapokibart 600-mg loading dose, then 300 mg every 2 weeks up to 52 weeks. Efficacy outcomes included the proportions of patients with ≥ 50%/75%/90% improvements from baseline of parent trials in the Eczema Area and Severity Index, Investigator's Global Assessment, and weekly average of the daily Peak Pruritus Numerical Rating Scale.

Results: In total, 127 patients were enrolled, and 110 (86.6%) completed the study. At week 52, the Eczema Area and Severity Index-50/75/90 response rates were 96.3%, 87.9%, and 71.0%, respectively. An Investigator's Global Assessment 0/1 with a ≥ 2-point reduction was achieved in 39.3% of patients at week 16, increasing to 58.9% at week 52. The proportions of patients with ≥ 3-point and ≥ 4-point reductions in the weekly average of daily Peak Pruritus Numerical Rating Scale scores were 80.2% and 62.2%, respectively, at week 52. Improvement in patients' quality of life was sustained over a 52-week treatment period. Treatment-emergent adverse events occurred in 88.2% of patients, with an exposure-adjusted event rate of 299.2 events/100 patient-years. Coronavirus disease 2019, upper respiratory tract infection, and conjunctivitis were the most common treatment-emergent adverse events.

Conclusions: Long-term treatment with stapokibart for 52 weeks showed high efficacy and good safety profiles, supporting its use as a continuous long-term treatment option for atopic dermatitis.

Clinical trial registration: ClinicalTrials.gov identifier: NCT04893707 (15 May, 2021).

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斯达博特对中重度特应性皮炎患者的长期疗效和安全性：一项开放标签延长、非随机临床试验。

背景：Stapokibart/CM310是一种靶向白细胞介素-4受体α链的人源化单克隆抗体，在之前的II期临床试验中显示出对中重度特应性皮炎患者有良好的治疗效果：我们旨在评估 stapokibart 对中重度特应性皮炎成人患者的长期疗效和安全性：入组的患者之前完成了 stapokibart 的母体试验，接受了 600 毫克的皮下注射 stapokibart 负荷剂量，然后每 2 周注射 300 毫克，直至 52 周。疗效结果包括湿疹面积和严重程度指数、研究者总体评估和每周瘙痒峰值数字分级表平均值较母体试验基线改善≥50%/75%/90%的患者比例：共有 127 名患者参加了研究，其中 110 人（86.6%）完成了研究。第52周时，湿疹面积和严重程度指数-50/75/90的应答率分别为96.3%、87.9%和71.0%。第16周时，39.3%的患者达到了研究者总体评估0/1，评分下降≥2分，第52周时，这一比例上升至58.9%。第52周时，瘙痒症日峰值数字评分量表的周平均评分≥3分和≥4分的患者比例分别为80.2%和62.2%。患者生活质量的改善在52周的治疗期内得以持续。88.2%的患者发生了治疗突发不良事件，暴露调整后的事件发生率为299.2起/100患者年。2019年冠状病毒病、上呼吸道感染和结膜炎是最常见的治疗突发不良事件：使用斯普托昔巴特进行52周的长期治疗显示出较高的疗效和良好的安全性，支持将其作为特应性皮炎的长期连续治疗方案：临床试验注册：ClinicalTrials.gov identifier：临床试验注册：ClinicalTrials.gov标识符：NCT04893707（2021年5月15日）。

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来源期刊

BioDrugs 医学-免疫学

CiteScore

12.60

自引率

2.90%

发文量

审稿时长

>12 weeks

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