Outcomes of Vogt-Koyanagi-Harada disease from a randomized clinical trial of antimetabolite therapies

Abstract

Purpose : Outcomes of Vogt-Koyanagi-Harada (VKH) disease have primarily been reported from retrospective studies with varied treatment regimens. Prospective studies are needed to assess the efficacy of specific immunosuppressive agents for controlling inflammation. We present outcomes of VKH from a subanalysis of a clinical trial of antimetabolite therapies for non-infectious intermediate, posterior, and pan- uveitis.

Methods : Eighty patients from Aravind Eye Hospitals, South India, were randomized to 25mg methotrexate weekly or 1g mycophenolate mofetil twice daily, with a corticosteroid taper. Clinical eye exams, visual acuity measurements, and optical coherence tomography scans were conducted monthly for 6 months. The primary outcome was corticosteroid-sparing (≤10 mg oral prednisone daily) control of inflammation. Secondary outcomes included visual acuity, central subfield thickness, and adverse events. Mixed effects regression models were used to account for within-person correlation between eyes.

Results : Forty-three patients (54%) carried a diagnosis of VKH and 38 completed follow-up. Seventeen of 23 patients (74%) on methotrexate achieved control of inflammation in both eyes compared to 8 of 15 patients (53%) on mycophenolate mofetil (p=0.30). The median (IQR) visual acuity at enrollment was 0.29 (0.02, 0.54) logMAR, or 20/40 (20/20, 20/70), Snellen equivalent. The median improvement in visual acuity was 9.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Eighty-five percent of patients with acute VKH and 50% of patients with chronic VKH achieved 20/20 vision. Patients with acute VKH gained 14.1 ETDRS letters more than those with chronic VKH (p=0.002), but there was no difference in corticosteroid-sparing control of inflammation (p=0.99). Twenty-six eyes with complete follow-up had a serous retinal detachment (SRD) at baseline and had acute disease. All SRDs resolved, and 88% of these eyes also achieved corticosteroid-sparing control of inflammation.

Conclusions : The majority of patients treated with antimetabolites and corticosteroids were able to achieve corticosteroid-sparing control of inflammation by 6 months with improved visual acuity. Although patients with acute VKH had greater visual improvement than those with chronic disease, this did not correspond to a higher rate of control of inflammation.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.