Efficacy and Safety of Ponesimod Compared with Teriflunomide in Female Patients with Relapsing Multiple Sclerosis: Findings from the Pivotal OPTIMUM Study
Language English Country United States Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Clinical Trial, Phase III, Research Support, Non-U.S. Gov't, Comparative Study
PubMed
38301149
DOI
10.1089/jwh.2023.0037
Knihovny.cz E-resources
- Keywords
- WOCBP, multiple sclerosis, ponesimod, teriflunomide, treatment, women,
- MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Hydroxybutyrates * MeSH
- Crotonates * therapeutic use adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Magnetic Resonance Imaging MeSH
- Nitriles * therapeutic use adverse effects MeSH
- Surveys and Questionnaires MeSH
- Multiple Sclerosis, Relapsing-Remitting * drug therapy MeSH
- Thiazoles adverse effects therapeutic use MeSH
- Toluidines * therapeutic use adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Hydroxybutyrates * MeSH
- Crotonates * MeSH
- Nitriles * MeSH
- ponesimod MeSH Browser
- teriflunomide MeSH Browser
- Thiazoles MeSH
- Toluidines * MeSH
Background: Multiple sclerosis (MS) is threefold more prevalent in women than men. However, sex-specific efficacy analysis for MS disease-modifying therapies is not typically performed. Methods: Post hoc analyses of data from female patients enrolled in the phase 3, double-blind OPTIMUM study of relapsing MS were carried out. Eligible adults were randomized to ponesimod 20 mg or teriflunomide 14 mg once daily for up to 108 weeks. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included change in symptom domain of Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) at week 108, number of combined unique active lesions (CUALs) per year on magnetic resonance imaging, and time to 12- and 24-week confirmed disability accumulation (CDA). Results: A total of 735 female patients (581 of childbearing potential) were randomized to ponesimod (n = 363, 49.4%) or teriflunomide (n = 372, 50.6%). Relative risk reduction in the ARR for ponesimod versus teriflunomide was 33.1% (mean, 0.192 vs. 0.286, respectively; p < 0.002). Mean difference in FSIQ-RMS for ponesimod versus teriflunomide was -4.34 (0.12 vs. 4.46; p = 0.002); rate ratio in CUALs per year, 0.601 (1.45 vs. 2.41; p < 0.0001), and hazard ratio for time to 12- and 24-week CDA risk estimates, 0.83 (10.7% vs. 12.9%; p = 0.38) and 0.91 (8.8% vs. 9.7%; p = 0.69), respectively. Incidence of treatment-emergent adverse events was similar between treatment groups (89.0% and 90.1%). Conclusions: Analyses demonstrate the efficacy and safety of ponesimod, versus active comparator, for women with relapsing MS, supporting data-informed decision-making for women with MS. Clinical Trial Registration Number: NCT02425644.
Department of Neurology 1st Medical Faculty Charles University Prague Czech Republic
Department of Neurology Harvard Medical School Brigham and Women's Hospital Boston Massachusetts USA
Global Medical Affairs Janssen Research and Development LLC Titusville New Jersey USA
Office of Chief Medical Officer Johnson and Johnson New Brunswick New Jersey USA
References provided by Crossref.org
ClinicalTrials.gov
NCT02425644
