Assessment of Changes in Quality of Life Among Subjects in the STOP-Uveitis Study

Abstract

Purpose : To examine the effects of Tocilizumab treatment on quality of life as assessed by visual function questionnaire among subjects in the STOP-Uveitis study.

Methods : STOP-Uveitis study is a randomized, open-label safety, efficacy and bioactivity clinical study evaluating the role of tocilizumab (TCZ) in subjects with non-infectious uveitis (NIU). Subjects with NIU were randomized in a 1:1 to receive monthly IV infusions of either 4mg/kg or 8 mg/kg TCZ, until month 6 (M6; primary endpoint). Starting at M6, subjects were treated based on a retreatment criteria until month 12 (M12). Primary outcome measures were mean change in visual acuity, vitreous haze and foveal thickness at M6. Out of 37 subjects in STOP-Uveitis, 27 were analyzed and the rest were excluded due to absence of quality of life data. The NEI visual function questionnaire (VFQ-25) was administered at baseline (BL), M6, and M12 to measure self-reported vision health status and the effects of visual impairment on visual function and general health. The NEI VFQ-25 manual was used to calculate scale conversions, and calculations of subscale and composite scores. Wilcoxon signed-ranked test was used to identify changes across the self-rated domains of the VFQ.

Results : 27 subjects completed the VFQ-25 at BL, while 21 subjects completed it at M6 and M12. Mean age of the study population was 44 ±18.4 years. 15 (55.6%) subjects were females. 21(77.8%) study subjects were diagnosed with Idiopathic uveitis at BL. Majority of the cases had panuveitis (59.2%). 11(40.7%) subjects were receiving treatment at the study enrollment; 5(18.5%) were receiving corticosteroid while 7(25.9%) were receiving immunomodulators. Overall, subjects showed a significant improvement in composite scores across the domains from BL to M6 and M12. The results from Wilcoxon ranked-sum showed a significant improvement from baseline to M6 in general vision (p=0.03) and mental health (p=0.03). At M12, significant improvement was seen in distance activities (p=0.04) and role difficulties (p=0.03) from BL (Table 1).

Conclusions : Treatment with Tocilizumab shows improvement in overall general vision, mental health, distance activities and vision specific role difficulties in subjects with non-infectious uveitis. Significant improvements are observed as early as month 6.
(Lisa Greer and Fayez Jawed contributed equally towards the abstract and serve as co-first authors.)

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

 

Table 1