Discussion
significantStrengths, late-phase VKH, poorer vision, VKH disease, late-phase VKH disease
ADVERSE EVENTS, DISEASE, VOGT-KOYANAGI-HARADA DISEASE, INTRAOCULAR INFLAMMATION
In this 26-week, comparative effectiveness trial involving patients with VKH disease, 75% of whom had a late-phase disease, we found that the immunosuppressant strategy with cyclosporine plus corticosteroids was non-inferior to the biologic strategy with adalimumab plus corticosteroids with respect to visual improvement. Of note, the systemic corticosteroid regimen used in this trial was different from that in standard care. The overall incidence of adverse events was similar with two types of treatment, while, there were fewer serious adverse events reported in the immunosuppressant group than in the biologic group in the trial.Our trial used a modified, non-standard, corticosteroid background therapy for the treatment of VKH disease. Specifically, for those with early-phase VKH disease, the initial prednisone dose was 30–40 mg per day (0.6–0.8 mg per kilogram per day). The daily dose of prednisone we commenced was lower than that in previous studies (1 mg per kilogram of body weight or higher)For patients with late-phase VKH disease, our initial prednisone dose was 20–30 mg per day (0.4–0.6 mg per kilogram per day). Such a corticosteroid regimen was chosen based on several considerations. First, the late-phase VKH disease is characterized by chronic recurrent intraocular inflammation requiring prolonged treatmentOur tapering strategy is also different from that used in standard care. Considering that corticosteroid therapy remains the mainstay of treatment of VKH disease and usually lasts over a year in real-world practiceIn this study, patients with late-phase VKH disease accounted for 75% of those enrolled. The specific prevalence of late-phase disease in this cohort may differ from that in other centers, in which late-phase VKH disease could be rarely seen due to early diagnosis and treatment. There seem to be unmet medical needs in patient with VKH disease in China, which have enabled us to recruit a number of patients with late-phase VKH disease during a relatively short period. Nevertheless, interpretation of findings may be limited by the fact that the majority of study participants were late-phase VKH disease. Generally, our study extended previous studies favoring the immunosuppression as a safe and effective option for late-phase VKH diseaseOverall, adalimumab plus corticosteroids resulted in less visual improvement in the point estimate than cyclosporine plus corticosteroids. This outcome was mainly due to the relatively modest visual improvement by adalimumab in the late-phase VKH disease. Some previous studies similarly showed that adalimumab effectively controlled intraocular inflammation in late-phase VKH disease but that visual improvement was not statistically significantStrengths of the trial include the involvement of refractory patients with poorer vision (ETDRS score of 20 letters or less) as compared with former trials to maximize real-world applicability and generalizabilitySeveral important limitations of our trial should be noted. First, as mentioned earlier, our tapering regimen of prednisone did not correspond to the standard tapering regimen for corticosteroid sparingIn conclusion, combined with a non-standard corticosteroid regimen, cyclosporine-based immunosuppressant strategy was found to be 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 had a late-phase disease.