Observational Study of Ofatumumab vs. Ocrelizumab in RRMS Patients
In an observational study involving 1,870 patients with relapsing-remitting multiple sclerosis (RRMS), ofatumumab was associated with a marginally higher annualized relapse rate (ARR) of 0.05 compared to 0.03 for ocrelizumab, resulting in a rate ratio of 1.65 (p = 0.018). However, no significant differences were found in relapse timing or MRI activity.
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Why it matters
This research is important as it compares two treatments for RRMS, highlighting a potential difference in relapse rates that clinicians need to consider when prescribing.
What this does not prove
The study design limits the ability to establish direct cause-and-effect relationships, and there may be residual bias affecting the results.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 1870 · total number of patients included in the study
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Yes
- Relevant MS type
- RRMS
- Publication date
- 2026-10-05
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
- Primary evidenceOfatumumab vs Ocrelizumab in Relapsing-Remitting Multiple Sclerosis: A Nationwide Cohort Study. ↗DOI: 10.1212/wnl.0000000000218545
Supporting passages (13)
study phaseCLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in patients with RRMS, ofatumumab is associated with a marginally increased ARR compared with ocrelizumab, with both drugs having very low ARRs.
study designThis was an observational cohort study based on data extracted from the Danish Multiple Sclerosis Registry.
subjectsPatients with RRMS initiating ofatumumab or ocrelizumab treatment were included between January 2022 and November 2025.
sample sizeRESULTS: A total of 1,870 patients were included in the study, of whom 485 started ocrelizumab treatment at baseline (mean age 41.1 years, 65.2% female) and 1,385 started ofatumumab (mean age 41.3 years, 72.0% female).
sample size basisRESULTS: A total of 1,870 patients were included in the study, of whom 485 started ocrelizumab treatment at baseline (mean age 41.1 years, 65.2% female) and 1,385 started ofatumumab (mean age 41.3 years, 72.0% female).
primary endpoint metIn the ITT analysis, the mean ARR was 0.05 (95% CI 0.04-0.06) for the ofatumumab group and 0.03 (0.02-0.04) for the ocrelizumab group, with a rate ratio of 1.65 (1.09-2.50) (p = 0.018).
relevant ms typesCLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in patients with RRMS, ofatumumab is associated with a marginally increased ARR compared with ocrelizumab, with both drugs having very low ARRs.
publication datePublication date: 2026-10-05
comparatorThe median follow-up time was 2.0 (interquartile range 1.3-2.7) years for the ofatumumab group and 2.5 (1.3-3.4) years for the ocrelizumab group.
primary endpointPrimary outcomes were annualized relapse rate (ARR) rate ratio between the ofatumumab and ocrelizumab groups and hazard ratio (HR) for time to first relapse.
follow upThe median follow-up time was 2.0 (interquartile range 1.3-2.7) years for the ofatumumab group and 2.5 (1.3-3.4) years for the ocrelizumab group.
findingsIn the ITT analysis, the mean ARR was 0.05 (95% CI 0.04-0.06) for the ofatumumab group and 0.03 (0.02-0.04) for the ocrelizumab group, with a rate ratio of 1.65 (1.09-2.50) (p = 0.018).
limitationsImportant limitations include the observational design and the risk of residual indication bias.
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