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Q. D. Nguyen, R. L. Beckman, E. Hatef Naimi, T. Barisani-Asenbauer, LUMINATE Study Group; Vision-Related Quality of Life Outcomes In Patients With Non-Infectious Active 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):5262.
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To evaluate the effect of LX211 on vision-related quality of life (QOL) in patients with non-infectious active posterior-segment uveitis (NIAPU) resulting from the LX211-01 study.
LX211-01 was a phase 3 multi-center, double-masked, placebo controlled, randomized study of LX211 for the treatment of NIAPU. Change from baseline (visit 1) in QOL 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) at visits 6 (wk 16) and 8 (wk 24) was evaluated as secondary endpoint in placebo and treatment groups (LX211 0.2, 0.4, 0.6 mg/kg, all BID).
217 patients in the LX211-01 study were included in QOL assessment. NEI-VFQ-25 was used to assess vision-target health status. All treatment (TX) groups were comparable with respect to mean overall composite score at baseline; scores ranged from 63.1 (placebo) to 74.1 (0.6 mg/kg). There were no statistically significant increases or decreases in mean composite score at wk 16 or 24 compared to BL in TX groups. However, there were numerical increases in individual NEI-VFG-25 composite score in LX211 0.4 and 0.6 groups. Near activities score increased in 0.4 group at wk 16 compared to BL (mean change: 2.0). It also increased in 0.4 and 0.6 groups at wk 24 (mean change: 6.6 and 3.2, respectively); in the placebo and 0.2 groups, score decreased by -0.6 and -4.4, respectively. Vision-specific mental health score improved in all LX211 tx groups at week 16 and 24 compared to BL. Vision specific role difficulties score improved in 0.4 and 0.6 at wk 16; there was improvement in score among all 3 TX groups at wk 24 compared to BL. Vision specific dependency score improved in all 3 TX groups at wk 24. Peripheral vision score improved in 0.4 and 0.6 groups at wk 16, and in 0.4 group at wk 24.Treatment groups were comparable with respect to EQ-5D and SF-36 scores at BL; no significant changes were noted between BL, wk 16, or wk 24 in any TX group.
The numerical increases in individual composite score with higher dosage of LX211, as detected by NEI-VFQ-25, suggest a trend towards a potential benefit to patients undergoing treatment for NIAPU. Further analysis and follow-up studies are needed to detect improvement in vision-related quality of life among these patients.
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