Health and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis

Abstract Objective To evaluate changes in health-related and vision-related quality of life (QoL) among patients with noninfectious uveitis who were treated with antimetabolites. Design Secondary analysis of a randomized controlled trial. Participants Patients with noninfectious uveitis from India, the United States, Australia, Saudi Arabia, and Mexico. Methods From 2013-2017, 216 participants were randomized to receive 25 mg weekly oral methotrexate or 1.5 g twice daily oral mycophenolate mofetil. Median changes in QoL were measured using Wilcoxon signed rank tests, and differences between treatment groups were measured using linear mixed models, adjusting for baseline QoL score, age, sex, and site. Among Indian patients, vision-related QoL scores from a general scale (NEI-VFQ) and a culturally specific scale (IND-VFQ) were compared using Pearson correlation tests. Main Outcome Measures Vision-related (NEI-VFQ and IND-VFQ) and health-related (PCS (physical component score) and MCS (mental component score) SF-36v2) QoL was measured at baseline, the primary endpoint (6 months or treatment failure before 6 months), and the secondary endpoint (12 months or treatment failure between 6-12 months). Results Among 193 participants who reached the primary endpoint, vision-related QoL increased from baseline by a median of 12.0 points (interquartile range (IQR)=1.0-26.1, NEI-VFQ scale), physical health-related QoL increased by a median of 3.6 points (IQR=-1.4-14.9, PCS SF-36v2), and mental health-related QoL increased by a median of 3.0 points (IQR=-3.7-11.9, MCS SF-36v2). These improvements in NEI-VFQ, SF-36v2 PCS, and SF-36v2 MCS scores were all significant (p 0.05 for all). NEI-VFQ and IND-VFQ scores for Indian participants were highly correlated at baseline and the primary and secondary endpoints (correlation coefficient=0.87, 0.80, 0.90, respectively). Conclusions Among patients treated with methotrexate or mycophenolate mofetil for uveitis, vision-related and health-related QoL significantly improved over the course of one year and did not differ by treatment allocation. These findings suggest that antimetabolites could improve overall patient well-being and daily functioning.