A randomized non-inferiority trial of therapeutic strategy with immunosuppressants versus biologics for Vogt-Koyanagi-Harada disease

作者全名："Zhong, Zhenyu; Dai, Lingyu; Wu, Qiuying; Gao, Yu; Pu, Yanlin; Su, Guannan; Lu, Xiaorong; Zhang, Fuxiang; Tang, Chong; Wang, Yao; Zhou, Chunjiang; Yang, Peizeng"

作者地址："[Zhong, Zhenyu; Dai, Lingyu; Wu, Qiuying; Gao, Yu; Pu, Yanlin; Su, Guannan; Lu, Xiaorong; Zhang, Fuxiang; Tang, Chong; Wang, Yao; Zhou, Chunjiang; Yang, Peizeng] Chongqing Med Univ, Chongqing Eye Inst, Affiliated Hosp 1, Chongqing Key Lab Ophthalmol, Chongqing, Peoples R China; [Zhong, Zhenyu; Dai, Lingyu; Wu, Qiuying; Gao, Yu; Pu, Yanlin; Su, Guannan; Lu, Xiaorong; Zhang, Fuxiang; Tang, Chong; Wang, Yao; Zhou, Chunjiang; Yang, Peizeng] Natl Clin Res Ctr Ocular Dis, Chongqing Branch, Municipal Div, Chongqing, Peoples R China"

通信作者："Yang, PZ (通讯作者)，Chongqing Med Univ, Chongqing Eye Inst, Affiliated Hosp 1, Chongqing Key Lab Ophthalmol, Chongqing, Peoples R China.; Yang, PZ (通讯作者)，Natl Clin Res Ctr Ocular Dis, Chongqing Branch, Municipal Div, Chongqing, Peoples R China."

来源：NATURE COMMUNICATIONS

ESI学科分类：　

WOS号：WOS:001018100800017

JCR分区：Q1

影响因子：14.7

年份：2023

卷号：14

期号：1

开始页：　

结束页：　

文献类型：Article

关键词：　

摘要："Different classes of biologic therapeutics have been assessed in the context of Vogt-Koyanagi-Harada disease. Here the authors compared cyclosporine immunosuppression or adalimumab in a randomised clinical trial for the treatment of patients with Vogt-Koyanagi-Harada disease and found non-inferiority upon treatment with cyclosporine. Biologics are increasingly used to treat Vogt-Koyanagi-Harada disease, but head-to-head comparisons with conventional immunosuppressants are lacking. Here in this randomized trial (Chinese Clinical Trial Registry, ChiCTR2100043061), we assigned 110 patients (27 early-phase and 83 late-phase) to cyclosporine-based immunosuppressant strategy (N = 56) or adalimumab-based biologic strategy (N = 54), each combined with a modified corticosteroid regimen. The primary outcome is change from baseline in best-corrected visual acuity at week 26. The margin of non-inferiority for cyclosporine is -7 letters. The primary outcome is 11.2 letters (95% CI, 7.5 to 14.9) in the cyclosporine group and 6.3 letters (95% CI, 3.1 to 9.6) in the adalimumab group (difference, 4.9; 95% CI, 0.2 to 9.5; P < 0.001 for non-inferiority). The between-group difference is -0.8 letters (95% CI, -6.1 to 4.5) in early-phase disease and 5.7 letters (95% CI, 0.2 to 11.2) in late-phase. Serious adverse events are reported less frequently in the cyclosporine group than in the adalimumab group (0.70 vs. 1.21 events per patient-year). Here, we report that combined with a non-standard corticosteroid regimen, cyclosporine-based immunosuppressant strategy is non-inferior to adalimumab-based biologic strategy by 26 weeks for visual improvement in a cohort of patients with Vogt-Koyanagi-Harada disease, 75% of whom have a late-phase disease."

基金机构："National Natural Science Foundation Key Program [81930023, 82230032]; Chongqing Key Laboratory of Ophthalmology (CSTC) [2008CA5003]"

基金资助正文："The work was supported by National Natural Science Foundation Key Program (81930023 and 82230032; P.Y.), and Chongqing Key Laboratory of Ophthalmology (CSTC, 2008CA5003; P.Y.). The funding agency had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript."