OPTIMUM
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Annualized Confirmed Relapse Rate | Rate ratio 0.695 | 0.536–0.902 | 0.0003 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Ponesimod
Sphingosine 1-phosphate receptor Edg-1 agonist
Compared with
- Teriflunomide
Dihydroorotate dehydrogenase inhibitor
Results by group
Annualized Confirmed Relapse Rate
From randomization to end of study (Week 108)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ponesimod 20 mg | 0.202 relapses per year | 0.165–0.246 | 567 |
| Teriflunomide 14 mg | 0.290 relapses per year | 0.244–0.345 | 566 |
Ponesimod 20 mg
Teriflunomide 14 mg
p = 0.0003; Rate ratio 0.695 (95% CI 0.536–0.902)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Ponesimod 20 mg | 565 | 49 (8.7%) | 0 |
| Teriflunomide 14 mg | 566 | 46 (8.1%) | 2 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Annualized Confirmed Relapse Rate
From randomization to end of study (Week 108)
Disability progressionRelapsesWalking and mobilityBladder, bowel and sexual functionAnnualized relapse rate defined as the number of confirmed relapses per subject-year.
Relapses
Other measures (5)
Change From Baseline in Fatigue-related Symptoms as Measured by the Symptoms Domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) Score to Week 108
Baseline to Week 108
FatigueQuality of life (reported by participants)Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108
Baseline to Week 108
MRI lesions12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
Baseline to Week 60 and 108 Weeks
Disability progression24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS
Baseline to 60 Weeks and 108 Weeks
Disability progression1. Change from baseline to Week 108 in fatigue-related symptoms as
Fatigue
Who could take part
Relapsing and progressive · 18 to 55
Inclusion Criteria: Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses). Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization. Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy. Exclusion Criteria: Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study. Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis
Papers
Results
Long-term safety and efficacy of ponesimod in participants with relapsing multiple sclerosis: results from the phase 3 OPTIMUM 5-year long term extension study.J Neurol · 2026
Results
Meaningful Change Thresholds and Fatigue Severity Points on Patient-Reported Outcomes by the Fatigue Symptoms and Impacts Questionnaire in Patients With Relapsing Multiple Sclerosis.Value Health · 2024
Results
Efficacy and Safety of Ponesimod Compared with Teriflunomide in Female Patients with Relapsing Multiple Sclerosis: Findings from the Pivotal OPTIMUM Study.J Womens Health (Larchmt) · 2024
Results
Matching-Adjusted Indirect Comparisons of Diroximel Fumarate, Ponesimod, and Teriflunomide for Relapsing Multiple Sclerosis.CNS Drugs · 2023
Results
An exposure-response analysis of ponesimod clinical efficacy in a randomized phase III study in patients with relapsing multiple sclerosis.CPT Pharmacometrics Syst Pharmacol · 2022
Results
Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial.JAMA Neurol · 2021
Results
Fox RJ, Tervonen T, Phillips-Beyer A, Sidorenko T, Boyanova N, Brooks A, Hennessy B, Jamieson C, Levitan B. The relevance of fatigue to relapse rate in multiple sclerosis: Applying patient preference data to the OPTIMUM trial. Mult Scler. 2023 Mar;29(3):427-435. doi: 10.1177/13524585221140270. Epub 2022 Dec 22.
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Linked trials
Extended by
OPTIMUM-LTPhase 3 · Completed
Links found where a registry record names another trial's registry number.
Related trials
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- Exploring the Efficacy and Safety of Siponimod in Patient…
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No longer available
No result found
History
Started
Jun 2015
Main results due
May 2019
Finished
May 2019
Results posted
Jun 2021
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