A randomized, double-blind phase III study to demonstrate the clinical similarity of biosimilar SCT630 to reference adalimumab in Chinese patients with moderate to severe plaque psoriasis
机构：[a]Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China[b]Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venereology, Shandong First Medical University & ShandongAcademy of Medical Sciences, Jinan, Shandong, China[c]Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China[d]Department of Dermatology, Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, China[e]Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China[f]Department of Dermatology, Changhai Hospital, Second Military Medical University, Shanghai, China[g]Department of Dermatology, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China[h]Department of Dermatology, Zhejiang provincial People’s Hospital, Hangzhou, Zhejiang, China[i]Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[j]Department of Dermatology, Qilu Hospital of Shandong University, Jinan, Shangdong, China[k]Department of Dermatology and Venereology, People’s Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Clinical Research Center for Dermatologic Diseases,Xinjiang Key Laboratory of Dermatology Research, Urumqi, Xinjiang, China[l]Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China[m]Department of Dermatology and Venereology, West China Hospital, Sichuan University, Chengdu, Sichuan, China四川大学华西医院[n]Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China[o]Department of Dermatology, Second Xiangya Hospital, Central South University, Changsha, Hunan, China[p]Department of Dermatology, Air Force Medical Center, Chinese People’s Liberation Army, Beijing, China[q]Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China[r]Department of Dermatology, the Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China[s]Department of Dermatology, Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China[t]Department of Dermatology, Peking Union Medical College Hospital, Beijing, China[u]Department of Dermatology, Affiliated Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China华中科技大学同济医学院附属协和医院[v]Beijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., No.31 Kechuang 7th Street, BDA, Beijing, China[w]Beijing Protein and Antibody R&D Engineering Center, Sinocelltech Ltd., No.31 Kechuang 7th Street, Beijing, China
Introduction: This phase III study aimed to compare the efficacy, safety, and immunogenicity of SCT630 with the reference adalimumab.Methods: A total of 367 Chinese patients with moderate-to-severe plaque psoriasis were randomly assigned to receive 80 mg of SCT630 or adalimumab subcutaneously at week 1, 40 mg at week 2, then 40 mg biweekly. At week 16, those with 50 % or more improvement in psoriasis area and severity index (PASI) were eligible to enter an extension period up to week 52. Patients on SCT630 continued the same treatment, whereas patients receiving adalimumab were re-randomized at a ratio of 1:1 to adalimumab or SCT630 group. The primary endpoint was percentage improvement in PASI at week 16. Other endpoints included PASI 50/75/90/100, Physician's Global Assessment, Dermatology Life Quality Index, safety, and immunogenicity.Results: PASI improvement at week 16 was 85.07 % for SCT630 and 84.82 % for adalimumab. The mean dif-ference (3.10 %, 95 % CI:-1.875 %, 8.066 %) was within the equivalence interval. Other efficacy endpoints, safety and immunogenicity profiles were similar across the two groups. There were no safety or immunogenicity difference between switched/continued groups.Conclusion: This phase III study demonstrated the equivalences in efficacy, safety and immunogenicity of SCT630 to adalimumab in patients with moderate to severe psoriasis.
基金：
Sinocelltech Ltd.; National Major Scientific and Technological Special Project for Significant New Drugs Innovation and Development [2018ZX09736002]
第一作者机构：[a]Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China
通讯作者：
通讯机构：[a]Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China[*a]Department of Dermatology, Xijing Hospital, Fourth Military Medical University, No.127, Changle West Road, Xincheng District, Xi’an City, Shaanxi Province, China.
推荐引用方式(GB/T 7714)：
Chen Yu,Furen Zhang,Yangfeng Ding,et al.A randomized, double-blind phase III study to demonstrate the clinical similarity of biosimilar SCT630 to reference adalimumab in Chinese patients with moderate to severe plaque psoriasis[J].INTERNATIONAL IMMUNOPHARMACOLOGY.2022,112:doi:10.1016/j.intimp.2022.109248.
APA：
Chen Yu,Furen Zhang,Yangfeng Ding,Yumei Li,Yi Zhao...&Gang Wang.(2022).A randomized, double-blind phase III study to demonstrate the clinical similarity of biosimilar SCT630 to reference adalimumab in Chinese patients with moderate to severe plaque psoriasis.INTERNATIONAL IMMUNOPHARMACOLOGY,112,
MLA：
Chen Yu,et al."A randomized, double-blind phase III study to demonstrate the clinical similarity of biosimilar SCT630 to reference adalimumab in Chinese patients with moderate to severe plaque psoriasis".INTERNATIONAL IMMUNOPHARMACOLOGY 112.(2022)
