Long-term safety and efficacy of ponesimod, an oral S1P1 receptor modulator, in relapsing-remitting multiple sclerosis (RRMS): Results from randomized phase 2b core and extension studies spanning up to 13 years.
Mult Scler Relat DisordJul 21, 2026 (epub)
Tomas Olsson, Xavier Montalban, Reinhard Hohlfeld et al.
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In 30 seconds
This study evaluated the long-term safety and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis (RRMS) over a period of up to 13 years, utilizing data from a randomized phase 2b trial and its extension. The mean annualized relapse rate (ARR) was 0.14, indicating sustained low disease activity.
Key findings
- 92.4% of participants experienced at least one treatment-emergent adverse event (TEAE).
- Mean annualized relapse rate (ARR) was 0.14 (95% CI: 0.10-0.20).
- Kaplan-Meier estimate for confirmed relapse was 52.5% (95% CI: 42.3-63.5).
- Mean T1 Gd+ lesions decreased from 2.62 at baseline to 0.26 at 12.4 years.
Why it matters
Understanding the long-term safety and efficacy of treatments like ponesimod is crucial for clinicians managing RRMS, as it informs treatment decisions and patient expectations regarding disease control and potential side effects.