EFFECT OF CENERIMOD ON QUALITY OF LIFE IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS: RESULTS FROM THE PHASE 2 CARE STUDY

PV170 / #460 Poster Topic: AS19 - Patient-Reported Outcome Measures Background/Purpose Cenerimod is an investigational highly selective S1P 1 receptor modulator with potential therapeutic benefits in autoimmune disease, including Systemic Lupus Erythematous (SLE). The Phase 2b CARE study was a double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of different doses of cenerimod (0.5 mg, 1 mg, 2 mg, or 4 mg) in subjects with moderate-to-severe SLE, concurrently receiving stable background therapy. Cenerimod had a significant effect on the primary endpoint, the change in modified SLE disease activity index-2000 score (mSLEDAI 2K, which excludes leukopenia) from baseline to month 6. The largest difference vs placebo was obtained in the 4 mg arm and was nominally statistically significant (4 mg: -4.04 vs placebo: -2.85, P=0.029). Further, post hoc subgroup analyses showed that 4 mg had a greater treatment effect size vs placebo (- 5.41 vs -2.62, P=0.0015) in patients with high IFN 1 gene expression at baseline. The CARE study also assessed health-related quality of life (QoL) as 1 of its endpoints, and the abstract presents the QoL results comparing cenerimod 4 mg to placebo. Methods The 36-Item Short-Form Health Survey version 2 (SF-36v2) was one of the tools used to assess quality of life (QoL) in the CARE study.[1] The data was collected using a paper clinical report form (CRF). Observed changes from baseline to month 6 were analyzed descriptively using the full analysis set. The SF-36v2 questionnaire covers 8 health domains and provides 2 component summaries, the physical and the mental components. A 2-point change in the physical component summary and a 3-point change in the mental component summary are considered as the minimal important differences (MIDs) indicating improvement in health status 1 . In this abstract, the results will focus on the 2 component summaries and on the mental health domain. Results Improvements were noted with cenerimod 4 mg vs placebo at month 6 across most of the SF-36v2 health domains. The mean [SD] change from baseline to month 6 with 4 mg was 4.72 [8.17] for the physical component summary (vs placebo, 2.60 [9.91]) (Table 1) and 2.73 [8.99] for the mental component summary (vs placebo, 2.51 [11.74]) (Table 2). In the subgroup of patients with high IFN-1 gene expression, the treatment effect was greater with a mean [SD] changes higher for 4 mg vs placebo in both physical (6.77 [7.80] vs 0.99 [9.81]) (Table 1) and mental components (3.14 [10.25] vs 0.75 [13.39]) (Table 2). For the SF-36 mental health domain at month 6, the mean [SD] difference was 3.02 with 4 mg vs 2.63 for placebo. In the high IFN-1 gene expression subgroup, the mean difference was 2.82 [9.76] for the 4 mg vs -0.07 [12.10] for the placebo. Table 1: SF-36v2: observed value at baseline and change from baseline at Month 6: Physical Component Table 2: SF-36v2: observad value at baseline and change from baseline at Month 6: Mental Component Conclusions Patients with cenerimod 4 mg groups showed meaning full improvements in the mental and physical components of the SF-36v2 scores compared to placebo at month 6. Further evaluation of the SF-36v2 scores will be performed in the phase III program. References: [1.] User’s manual for the SF-36v2 survey. 3rd ed. 2011.

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