A Novel Risk Stratification-Based Immunomodulatory Treatment Strategy for Vogt-Koyanagi-Harada Disease

center dot PURPOSE: To develop a more tailored immunomodulatory treatment (IMT) strategy based on a novel 2arm risk stratification system in Vogt-Koyanagi-Harada (VKH) patients. center dot DESIGN: A retrospective clinical cohort study. center dot METHODS: Seventy-nine VKH patients in the acute stage were stratified into low- (n = 58) and high -risk (n = 21) groups based on their exposure to risk factors. They were treated with oral glucocorticoids (GCs) plus as -needed (PRN) or first -line IMT. Best corrected visual acuity (BCVA), sunset glow fundus (SGF) occurrence, relapse rate, and systemic adverse events were evaluated during follow-up. center dot RESULTS: Compared with the low -risk group, the high -risk group showed poorer BCVA at baseline (estimated difference 0.51, 95% CI 0.30-0.78; P < .001) and 6 -month follow-up (estimated difference 0.08, 95% CI 0.00-0.08; P = .006), higher incidence of SGF at 12 months (52% vs 28%; RR 1.9, 95% CI 1.1-3.4; P = .040), and higher relapse rate at 6 months (24% vs 5%; RR 4.6, 95% CI 1.2-17.5; P = .028) and 12 months (52% vs 12%; RR 4.4, 95% CI 1.9-9.7; P < .001). In the low -risk cohort, no significant difference between the 2 IMT strategies was observed in primary outcomes. In the high -risk cohort, patients with the immediate IMT showed better BCVA (estimated difference -0.20, 95% CI -0.3 to -0.08; P = .007), lower incidence of SGF (27% vs 80%; RR 0.3, 95% CI 0.1-0.9; P = .030), and lower relapse rate (27% vs 80%; RR 0.3, 95% CI 0.10.9; P = .030) compared with the PRN regimen. Moreover, the immediate IMT regimen had a higher frequency of systemic adverse events than the PRN regimen (47% vs 7%; RR 7.1, 95% CI 2.5-20.4; P < .001). center dot CONCLUSIONS: High -risk stratification at baseline was associated with poor prognosis. The immediate IMT regimen was only beneficial for high -risk VKH patients regarding visual outcome, SGF, and relapse rate. This study suggests a potential need for a customized IMT strategy for VKH patients. (Am J Ophthalmol 2024;262: 25- 33. (c) 2024 Elsevier Inc. All rights reserved.)