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Old 05-14-2020, 02:27 PM
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Default Study on Mayzent (siponomod) for SPMS

A poster session from ACTRIMS 2020

P030: Analyses Of The Effect Of Disease Duration On The Efficacy And Safety Of Siponimod In Patients With Active SPMS From The Expand Study

A. Bar-Or, S. L. Cohan, P. K. Coyle, et al

Background: Siponimod (MayzentŪ) is a selective sphingosine 1-phosphate receptor (S1P1 and S1P5) modulator, approved in the USA for treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS (SPMS). In the phase 3 EXPAND registration trial in SPMS, siponimod significantly reduced risk of 3 (primary endpoint) and 6 month confirmed disability progression (CDP) by 21% and 26%, respectively.

Objectives: Assess efficacy and safety of siponimod in patients with active SPMS in subgroups of patients with MS duration (time since onset of first symptoms) of <16 or ⩾16 years ([y] median value) at baseline.

Methods: Post hoc analyses were performed in patients with active SPMS, defined as a relapse in the 2 y before screening and/or ⩾1 T1 Gd+ lesion at baseline, randomized to siponimod 2 mg qd or placebo. Efficacy endpoints: time to 3 and 6 month CDP (as per Expanded Disability Status Scale scores). Adverse events (AEs), serious AEs, and AEs leading to treatment discontinuation were assessed. Analyses for hypothesis generation, without adjustment for multiple comparisons.

Results: There were 779 patients with active SPMS: 427 with MS duration <16 y (siponimod n=285; placebo, n=142) and 352 with ⩾16 y duration (siponimod n=231; placebo, n=121). For MS duration of <16 y, siponimod reduced 3 and 6 month CDP risk by 32.4% and 42.7%, respectively, versus placebo (3 month: siponimod, n=68 [23.9%]; placebo, n=48 [33.8%]; hazard ratio [HR], [95% confidence interval (CI)]: 0.68, [0.47, 0.98]; p=0.0378; 6 month: siponimod, n=48 [16.8%]; placebo, n=40 [28.2%]; HR, [95% CI]: 0.57, [0.38, 0.87]; p=0.0093). For MS duration ⩾16 y, siponimod had a trend towards reduced 3 and 6 month CDP risk of 31.9% and 27.1%, respectively, versus placebo (3 month: siponimod, n=61 [26.4%]; placebo, n=43 [35.5%]; HR, [95% CI]: 0.68, [0.46, 1.01]; p=0.0540; 6 month, siponimod, n=51 [22.1%]; placebo, n=34 [28.1%]; HR, [95% CI]: 0.73, [0.47, 1.13]; p=0.1544). Siponimod was generally well tolerated. Any AE rates were: <16 y, 84.9% (siponimod), 75.4% (placebo); ⩾16 y, 89.2% (siponimod), 81.8% (placebo).

Conclusions: In patients with active SPMS and MS duration <16 years, siponimod significantly reduced 3 and 6 month CDP risk compared with placebo. Siponimod showed a trend towards reduced CDP versus placebo in those with duration ⩾16 years. This may reflect the smaller size or more advanced disease in this subgroup.
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