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

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发表日期：

2024年7月31日

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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

摘要

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).