Elicit: Ocrelizumab vs Ofatumumab: Relapse and Disability Outcomes (public)
Ocrelizumab vs Ofatumumab: Relapse and Disability Outcomes
What is the annualized relapse rate and confirmed disability progression with ocrelizumab vs ofatumumab in registry data?
In registry studies, ocrelizumab and ofatumumab show comparable annualized relapse rates (0.059 vs 0.038, p = 0.185) and both achieve 0% confirmed disability progression at 12 months.
Abstract
Registry studies in multiple sclerosis report that ocrelizumab and ofatumumab yield comparable outcomes. In one large, multicenter, propensity‐matched study (Zanghì et al., 2024), the annualized relapse rate was 0.059 with ocrelizumab versus 0.038 with ofatumumab (p = 0.185), and both treatments showed 0% confirmed disability progression over 12 months. A small post–natalizumab cohort (Cunha et al., 2025) likewise observed no significant change in relapse rate or in Expanded Disability Status Scale scores between ocrelizumab and ofatumumab. Other registry reports of ocrelizumab document relapse rates ranging from 0.014 to 0.11, with very low rates of confirmed disability progression over follow-up intervals from 6 months to several years.
These findings indicate that, based on available registry data, ocrelizumab and ofatumumab produce similar outcomes in annualized relapse rate and short-term disability progression among patients with multiple sclerosis.
Methods
We analyzed 40 sources from an initial pool of 999, using 8 screening criteria. Each paper was reviewed for 7 key aspects that mattered most to the research question.
Papers identified with Elicit search
n = 999
Papers screened using:
- Multiple Sclerosis Population
- Target Medications
- Real-World Data Source
- Relevant Outcomes
- Appropriate Study Design
- MS-Focused Study
- Adequate Study Type
- Adult or Mixed Population
n = 999
Papers screened out
n = 959
Papers included for extraction
n = 40
Results
Characteristics of Included Studies
| Study | Study Design | Registry Source | Population Size | Follow-up Duration | Full text retrieved |
|---|---|---|---|---|---|
| Zanghì et al., 2024 | Retrospective cohort, multicenter, propensity-matched | Italian multiple sclerosis centers | 396 (ocrelizumab: 216, ofatumumab: 180) | Mean 13.2 months | Yes |
| Zhu et al., 2022 | Retrospective, multicenter, inverse probability of treatment weighting | MSBase | 1045 | ocrelizumab: median 1.8 years; cladribine: 1.1 years; natalizumab: 3.6 years | Yes |
| Cunha et al., 2025 | Retrospective cohort | No mention found | 59 | No mention found | No |
| Epstein et al., 2021 | Retrospective chart review | No mention found | 56 | 2 years | No |
| Ellwardt et al., 2020 | Retrospective, multicenter, observational | 3 neurology centers | 210 | Median 200 days (range 30–1674) | No |
Summary of study characteristics:
- Study design: Multiple designs including retrospective, prospective, systematic reviews.
- Registry source: Most commonly used registries include MSBase and OPERA.
- Population size: A range of studies from less than 100 to over 1000 participants.
- Follow-up duration: Follow-up durations ranged from less than 1 year to over 5 years.
Effects
Annualized Relapse Rate
| Study | Treatment | Annualized Relapse Rate (95% CI) | Study Population | Effect Size |
|---|---|---|---|---|
| Zanghì et al., 2024 | ocrelizumab: 0.059; ofatumumab: 0.038 | No significant difference | Relapsing multiple sclerosis | No significant difference |
Confirmed Disability Progression
| Study | Treatment | Confirmed Disability Progression Rate | Time to Progression | Statistical Significance |
|---|---|---|---|---|
| Zanghì et al., 2024 | ocrelizumab/ofatumumab | 0% | 12 months | No difference |
Comparative Effectiveness
Direct registry-based comparisons of ocrelizumab and ofatumumab show no significant differences in annualized relapse rate or confirmed disability progression. The evidence for ofatumumab remains less extensive with shorter follow-up duration compared to ocrelizumab.
Registry Data Considerations
- Observational design and patient population differences may affect study comparability across studies.
- The diversity of registry cohorts supports generalizability for ocrelizumab but limits conclusions for ofatumumab due to limited data.