Ocrelizumab No Evidence of Disease Activity (NEDA) Status at 96 Weeks 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 (PL02.004)
Bibliographic record
Abstract
Objective: To evaluate the effect of ocrelizumab vs interferon beta-1a (IFNβ-1a) on achieving no evidence of disease activity (NEDA) in patients with relapsing MS over 96 weeks in two identical Phase III, randomized, double-blind, double-dummy trials (OPERA I and OPERA II). Background: MS treatment goals are evolving with the emergence of higher-efficacy therapies. NEDA is a composite measure of the absence of clinical and MRI findings and a rapidly emerging treatment goal. 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. NEDA (defined as no relapses, confirmed disability progression [CDP], new/enlarging T2 lesions, or gadolinium-enhancing T1 lesions) was analyzed over 96 weeks. MRI was assessed at baseline, 24, 48, and 96 weeks. Results: At 96 weeks, 47.9[percnt] and 47.5[percnt] of ocrelizumab-treated patients vs 29.2[percnt] and 25.1[percnt] of IFNβ-1a-treated patients achieved NEDA in OPERA I (64[percnt] increase; p<0.0001) and OPERA II (89[percnt] increase; p<0.001), respectively: 80.4[percnt] and 78.9[percnt] of ocrelizumab-treated patients vs 66.7[percnt] and 64.5[percnt] of IFNβ-1a-treated were without relapses; 92.4[percnt] and 89.4[percnt] of ocrelizumab-treated patients vs 87.8[percnt] and 84.9[percnt] of IFNβ-1a-treated were without CDP; 91.7[percnt] and 90.2[percnt] of ocrelizumab-treated patients vs 69.8[percnt] and 63.9[percnt] of IFNβ-1a-treated were without gadolinium-enhancing T1 lesions; and 61.7[percnt] and 60.9[percnt] of ocrelizumab-treated patients vs 38.7[percnt] and 38.0[percnt] of IFNβ-1a-treated were without new/enlarging T2 lesions in OPERA I and OPERA II, respectively. After week 24, ≥96.0[percnt] of all ocrelizumab-treated patients compared with 60.8-70.9[percnt] of IFNβ1-a-treated patients were without new/enlarging T2 lesions. Conclusions: Ocrelizumab consistently resulted in greater achievement of NEDA vs IFNβ-1a over 96 weeks, with elimination of new/enlarging T2 lesions in nearly all patients after week 24. Supported by F. Hoffmann-La Roche
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".