Effect of Ocrelizumab on Disability Progression in Patients with Relapsing Multiple Sclerosis: Analysis of the Phase III, Double-Blind, Double-Dummy, Interferon Beta-1a-Controlled OPERA I and OPERA II Studies (S49.008)
Bibliographic record
Abstract
Objective: To evaluate the effect of ocrelizumab vs interferon beta-1a (IFNβ-1a) on disability progression in relapsing MS (RMS) in two identical Phase III, randomized, double-blind, double-dummy trials (OPERA I and OPERA II). Background: Disease progression is inevitable for most patients with RMS despite currently available treatments. Selective B-cell targeting may be a potential therapeutic approach for MS, particularly early in the disease course when suppressing inflammation will most likely impact disability accrual. Ocrelizumab is a humanized monoclonal antibody that selectively targets CD20+ B cells. Methods: In OPERA I and OPERA II, patients were randomized (1:1) to receive ocrelizumab 600mg via intravenous infusion every 24 weeks or subcutaneous IFNβ-1a 44μg three-times weekly over 96 weeks. Time to onset of ≥12-week and ≥24-week confirmed disability progression (CDP) and the proportion of patients with improved, stable, or worsened Expanded Disability Status Scale (EDSS) score from baseline were assessed at week 96. Results: Compared with IFNβ-1a-treated patients, lower proportions of ocrelizumab-treated patients had 12-week CDP (9.1[percnt] vs 13.6[percnt]; risk reduction: 40[percnt]; p=0.0006) and 24-week CDP (6.9[percnt] vs 10.5[percnt]; risk reduction: 40[percnt]; p=0.0025) at week 96 in a pre-specified pooled analysis of OPERA I and OPERA II; results were similar in individual OPERA I and OPERA II analyses. Higher proportions of ocrelizumab-treated patients had improved/stable disability (OPERA I: 92.3[percnt]; OPERA II: 87.5[percnt]) vs IFNβ-1a-treated patients (OPERA I: 86.1[percnt]; OPERA II: 80.4[percnt]), and significantly fewer patients had worsened disability with ocrelizumab vs IFNβ-1a in OPERA I (7.7[percnt] vs 13.9[percnt] [adjusted odds ratio (aOR) 0.559; p=0.0242]) and OPERA II (12.5[percnt] vs 19.6[percnt] [aOR 0.577; p=0.0121]). Conclusions: The efficacy of ocrelizumab in these EDSS analyses substantiates the CDP results from the OPERA trials. These results show that CD20+ B-cell targeting with ocrelizumab has a robust effect in reducing disability progression in MS. Supported by F. Hoffmann-La Roche
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".