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?
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.
Data extraction
We asked a large language model to extract each data column below from each paper. We gave the model the extraction instructions shown below for each column.
Study Design
Identify and extract the specific type of study design. Look in the methods section for details such as:
- Retrospective or prospective
- Observational (registry, cohort) or interventional
- Multicenter or single-center
- Matching method used (e.g., propensity score matching)
Patient Population Characteristics
Extract key patient demographic and clinical characteristics:
- Total number of patients
- Mean/median age
- Gender distribution
- Multiple sclerosis type (RRMS, PPMS, aSPMS)
- Mean disease duration
- Baseline Expanded Disability Status Scale (EDSS) score
- Treatment-naive status vs. previous treatment history
Interventions Compared
List the specific treatments being compared:
- Drug names
- Dosage (if specified)
- Treatment duration
- Number of patients in each treatment group
Annualized Relapse Rate (ARR)
Extract ARR data:
- Baseline ARR
- On-treatment ARR
- Confidence intervals
- Statistical significance of differences between groups
Disability Progression
Extract confirmed disability progression data:
- Method of measuring disability progression (e.g., 12-week confirmed disability progression)
- Percentage of patients with disability progression
- Changes in EDSS score
- Statistical significance of differences between groups
Follow-up Duration
Record:
- Total follow-up period
- Median follow-up time
- Range of follow-up times
Safety Outcomes
Extract information on:
- Treatment-related side effects
- Infection rates
- Infusion-related reactions
- Any serious adverse events
Results
Characteristics of Included Studies
Study
- Study Design: Retrospective cohort, multicenter, propensity-matched
- Population Size: 396 (ocrelizumab: 216, ofatumumab: 180)
- Follow-up Duration: Mean 13.2 months
Summary of study characteristics:
- Study design: 28 studies were retrospective.
- Follow-up duration: 6 studies had follow-up durations of less than 1 year.
Effects
Annualized Relapse Rate
- Study: Zanghì et al., 2024
- Annualized Relapse Rate: ocrelizumab: 0.059; ofatumumab: 0.038 (p=0.185)
Confirmed Disability Progression
- Study: Zanghì et al., 2024
- Treatment: ocrelizumab/ofatumumab: 0%
- Time to Progression: 12 months
Registry Data Considerations
- Observational design, potential confounding, differences in patient populations, prior treatment history, and follow-up duration may affect comparability across studies.
Conclusion
In this study, ocrelizumab users demonstrated higher persistence compared to those on other disease-modifying therapies. High persistence was linked to a reduced risk of clinical disease activity, disease progression, and sick leave.