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

Zhenyu Zhong, Lingyu Dai, Qiuying Wu, Yu Gao, Yanlin Pu, Guannan Su, Xiaorong Lu, Fuxiang Zhang, Chong Tang, Yao Wang, Chunjiang Zhou and Peizeng Yang ()
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Zhenyu Zhong: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Lingyu Dai: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Qiuying Wu: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Yu Gao: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Yanlin Pu: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Guannan Su: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Xiaorong Lu: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Fuxiang Zhang: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Chong Tang: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Yao Wang: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Chunjiang Zhou: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases
Peizeng Yang: The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory of Ophthalmology, Chongqing Eye Institute, and Chongqing Branch (Municipality Division) of National Clinical Research Center for Ocular Diseases

Nature Communications, 2023, vol. 14, issue 1, 1-10

Abstract: Abstract 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

Date: 2023
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DOI: 10.1038/s41467-023-39483-5

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