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

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 < 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.

• Authors: Zhenyu Zhong, Lingyu Dai, Qiuying Wu, Yu Gao, Yanlin Pu, Guannan Su, Xiaorong Lu, Fuxiang Zhang, Chong Tang, Yao Wang, Chunjiang Zhou, Peizeng Yang
• Journal: Nature communications (Nat Commun) Vol. 14 Issue 1 Pg. 3768 (06 24 2023) ISSN: 2041-1723 [Electronic] England
• PMID: 37355662 (Publication Type: Randomized Controlled Trial, Equivalence Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023. The Author(s).

Chemical References

• Immunosuppressive Agents
• Adalimumab
• Cyclosporine
• Biological Products

Topics

• Humans
• Immunosuppressive Agents (therapeutic use)
• Uveomeningoencephalitic Syndrome (drug therapy)
• Adalimumab (therapeutic use)
• Cyclosporine (therapeutic use)
• Biological Products (therapeutic use)