Quality of Life Outcomes from a Randomized Controlled Trial Comparing Methotrexate to Mycophenolate Mofetil for Noninfectious Uveitis

Abstract

Purpose : To evaluate the changes in quality of life in noninfectious uveitis patients treated with two of the most commonly prescribed antimetabolite treatments.

Methods : Secondary analysis of a multicenter, block-randomized, observer-masked clinical trial (ClinicalTrials.gov NCT01232920). Eighty patients at Aravind Eye Hospitals in Madurai and Coimbatore, India, with noninfectious intermediate, posterior, or panuveitis were randomized to receive oral methotrexate, 25 mg weekly, or oral mycophenolate mofetil, 1 g twice daily, and were followed up monthly for 6 months. Best-corrected visual acuity, IND-VFQ, and SF-36 were obtained at enrollment and at 6 months (or prior in the event of early treatment failure). Changes in quality of life scores were compared using Wilcoxon signed-rank testing. The associations with visual acuity, treatment arm, and treatment outcome, as defined by corticosteroid-sparing control of inflammation, were assessed using linear regression models.

Results : IND-VFQ scores, on average, increased by 9.2 points from trial enrollment to 6 months (95% CI: 4.9, 13.5, P <0.001). While the SF-36 physical component summary score did not significantly differ over the course of the trial, the mental component summary score decreased by 2.3 points (95% CI: -4.4, -0.1, P=0.04) and the vitality subscale decreased by 3.5 points (95% CI: -5.6, -1.4, P=0.001). Patients that achieved corticosteroid sparing control of inflammation had an average 4.3 point higher increase in general health scores than patients who did not (95% CI: 0.3, 8.2, P=0.04). Quality of life scores did not differ between treatment arms. Linear regression modeling showed a 3.2 point improvement in IND-VFQ score for every 5 letter improvement in visual acuity (95% CI: 1.9, 4.3; P<0.001).

Conclusions : Although uveitis treatment was associated with a significant increase in vision and vision-related quality of life, patient-reported physical health did not change after 6 months of treatment and mental health decreased. Despite improved visual outcomes, uveitis patients receiving systemic immunosuppressive therapy may experience a deterioration in overall health-related quality of life.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.