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

Yan Zhao¹, Jing-Yi Li², Bin Yang³, Yang-Feng Ding⁴, Li-Ming Wu⁵, Li-Tao Zhang⁶, Jin-Yan Wang⁷, Qian-Jin Lu^{8

9

10

11}, Chun-Lei Zhang¹², Fu-Ren Zhang¹³, Xiao-Hong Zhu¹⁴, Yu-Mei Li¹⁵, Xiao-Hua Tao¹⁶, Qing-Chun Diao¹⁷, Lin-Feng Li¹⁸, Jian-Yun Lu¹⁹, Xiao-Yong Man²⁰, Fu-Qiu Li²¹, Xiu-Juan Xia²², Jiao-Ran Song²³, Ying-Min Jia²³, Li-Bo Zhang²³, Bo Chen²³, Jian-Zhong Zhang²⁴

Affiliations

¹ Department of Dermatology, Peking University People's Hospital, No. 11, Xizhimen South Street, Beijing, 100044, China.
² Department of Dermatovenereology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, China.
³ Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, 510091, Guangdong, China.
⁴ Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine, Shanghai, 200443, China.
⁵ Department of Dermatology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310006, Zhejiang, China.
⁶ Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, 300120, China.
⁷ Department of Dermatology, Ningbo No.2 Hospital, Ningbo, 315010, Zhejiang, China.
⁸ Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, 210042, Jiangsu, China.
⁹ Key Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, 210042, Jiangsu, China.
¹⁰ Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Nanjing, 210042, Jiangsu, China.
¹¹ Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, 410011, Hunan, China.
¹² Department of Dermatology, Peking University Third Hospital, Beijing, 100191, China.
¹³ Hospital for Skin Diseases, Shandong First Medical University; Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences, Jinan, 250022, Shandong, China.
¹⁴ Department of Dermatology, Wuxi No. 2 People's Hospital (Jiangnan University Medical Center), Wuxi, 214002, Jiangsu, China.
¹⁵ Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, 212001, Jiangsu, China.
¹⁶ Department of Dermatology, Zhejiang Provincial People's Hospital, Hangzhou, 310014, Zhejiang, China.
¹⁷ Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400011, China.
¹⁸ Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.
¹⁹ Department of Dermatology, The Third Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China.
²⁰ Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310009, Zhejiang, China.
²¹ Department of Dermatology, The Second Hospital of Jilin University, Changchun, 130041, Jilin, China.
²² Department of Dermatology, Qingdao University Medical College Affiliated Yantai Yuhuangding Hospital, Yantai, 264000, Shandong, China.
²³ Keymed Biosciences (Chengdu) Co., Ltd, Chengdu, 610219, Sichuan, China.
²⁴ Department of Dermatology, Peking University People's Hospital, No. 11, Xizhimen South Street, Beijing, 100044, China. rmzjz@126.com.

PMID: 39080181
DOI: 10.1007/s40259-024-00668-z

Clinical Trial

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

Yan Zhao et al. BioDrugs. 2024 Sep.

. 2024 Sep;38(5):681-689.

doi: 10.1007/s40259-024-00668-z. Epub 2024 Jul 31.

Authors

Affiliations

¹ Department of Dermatology, Peking University People's Hospital, No. 11, Xizhimen South Street, Beijing, 100044, China.
² Department of Dermatovenereology, West China Hospital of Sichuan University, Chengdu, 610041, Sichuan, China.
³ Department of Dermatology, Dermatology Hospital of Southern Medical University, Guangzhou, 510091, Guangdong, China.
⁴ Department of Dermatology, Shanghai Skin Disease Hospital, Institute of Psoriasis, Tongji University School of Medicine, Shanghai, 200443, China.
⁵ Department of Dermatology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310006, Zhejiang, China.
⁶ Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, 300120, China.
⁷ Department of Dermatology, Ningbo No.2 Hospital, Ningbo, 315010, Zhejiang, China.
⁸ Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, 210042, Jiangsu, China.
⁹ Key Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, 210042, Jiangsu, China.
¹⁰ Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Nanjing, 210042, Jiangsu, China.
¹¹ Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, 410011, Hunan, China.
¹² Department of Dermatology, Peking University Third Hospital, Beijing, 100191, China.
¹³ Hospital for Skin Diseases, Shandong First Medical University; Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences, Jinan, 250022, Shandong, China.
¹⁴ Department of Dermatology, Wuxi No. 2 People's Hospital (Jiangnan University Medical Center), Wuxi, 214002, Jiangsu, China.
¹⁵ Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, 212001, Jiangsu, China.
¹⁶ Department of Dermatology, Zhejiang Provincial People's Hospital, Hangzhou, 310014, Zhejiang, China.
¹⁷ Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400011, China.
¹⁸ Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, China.
¹⁹ Department of Dermatology, The Third Xiangya Hospital of Central South University, Changsha, 410013, Hunan, China.
²⁰ Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310009, Zhejiang, China.
²¹ Department of Dermatology, The Second Hospital of Jilin University, Changchun, 130041, Jilin, China.
²² Department of Dermatology, Qingdao University Medical College Affiliated Yantai Yuhuangding Hospital, Yantai, 264000, Shandong, China.
²³ Keymed Biosciences (Chengdu) Co., Ltd, Chengdu, 610219, Sichuan, China.
²⁴ Department of Dermatology, Peking University People's Hospital, No. 11, Xizhimen South Street, Beijing, 100044, China. rmzjz@126.com.

PMID: 39080181
DOI: 10.1007/s40259-024-00668-z

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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References

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

Affiliations

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

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical