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T. Barisani-Asenbauer, R. Beckman, Q. D. Nguyen, LUMINATE Study Group; Gender Differences in Vision-Related Quality of Life in Patients With Non-Infectious Posterior-Segment Uveitis From a Randomized Control, Multicenter Study of LX211 (LuveniqTM/Voclosporin Oral Capsules) - A Next-Generation Calcineurin Inhibitor. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5876.
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To evaluate gender differences in vision-related quality of life (QOL) in patients with non-infectious uveitis involving the intermediate- and posterior ocular segments resulting from the LX211-01 and LX211-02 studies.
LX211-01 and LX211-02 were two phase 3 multi-center, double-masked, placebo controlled, randomized studies of LX211 for the treatment of non-infectious uveitis. LX211-01 randomized patients with active disease whereas LX211-02 patients with controlled uveitis. QoL Data was evaluated using the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), Euro QoL-5 domains (EQ-5D), and QoL 36-item Short Form Health Survey (SF-36).
410 patients were included for QoL assessment (190 from study LX211-01, 220 from study LX211-02). In both groups ~ 62% of the subjects were female. When comparing QoL Data from baseline the mean NEI-VFQ-25 composite score showed a significant difference between male subjects yielding a score of 75.0 and women reaching only 69.8 in the active LX211-01 study (p=0.011). In the LX211-02 study the mean NEI-VFQ-25 score was comparable in both groups (men: 77.3; women: 73.1). For the SF-36 health survey differences were found for both active and controlled disease: SF36 total score LX211-01: men: 78.6; women: 73.1 (p=0.02); LX211-02: men: 78.3, women: 73.1 (p=0.037); SF36 mental health: LX211-01: men: 77.2 women: 71.9 (p=0.049); LX211-02: m: 76.3 w: 71.4 (p=0.066); SF36 physical health:LX211-01: men: 80.0 women: 74.2 (p=0.03); LX211-02: men:80.0 women: 74.7 (p=0.034). No differences were found in the Euro QoL-5 scores between male and female subjects in neither active nor controlled disease.
The LUMINATE Uveitis program enables for the first time the analysis of health related QoL (HRQOL) in a large cohort of non-infectious posterior segment uveitis patients. Further research will need to focus on the causes of the differences found between male and female subjects and on potential interventions to improve HRQOL of patients with uveitis.
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