Effect of Ocrelizumab on MRI Inflammatory and Neurodegenerative Markers of Disease 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 (S49.002)
Bibliographic record
Abstract
Objective: To evaluate the effect of ocrelizumab vs interferon beta-1a (IFNβ-1a) on MRI outcomes in patients with relapsing MS enrolled in two identical Phase III, randomized, double-blind, double-dummy trials (OPERA I and OPERA II). Background: In MS, there is an interdependence between inflammation and neurodegeneration, which could be mediated through B-cell and T-cell interactions. MRI is used to evaluate inflammatory and neurodegenerative markers of MS. 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. Brain MRI endpoints included the total number of T1 gadolinium-enhancing lesions, new/enlarging T2 hyperintense lesions, and new T1 hypointense lesions at weeks 24, 48, and 96, and change in whole brain volume from baseline and week 24 to week 96. Results: Compared with IFNβ-1a, ocrelizumab reduced T1 gadolinium-enhancing lesions by 94[percnt] in OPERA I and 95[percnt] in OPERA II (both p<0.0001); new/enlarging T2 hyperintense lesions by 77[percnt] in OPERA I and 83[percnt] in OPERA II (both p<0.0001); new T1 hypointense lesions by 57[percnt] in OPERA I and 64[percnt] in OPERA II (both p<0.0001); and brain volume loss from baseline to week 96 by 23.5[percnt] (p<0.0001) and 23.8[percnt] (p=0.0001) and from week 24 to week 96 by 22.7[percnt] (p=0.0042) and 14.9[percnt] (p=0.0900) in OPERA I and OPERA II, respectively. Conclusions: Ocrelizumab significantly and consistently suppressed inflammatory and neurodegenerative markers of disease on MRI vs IFNβ-1a in OPERA I and OPERA II over 96 weeks, with near-complete elimination of new T1 gadolinium-enhancing lesions following the first dose. The majority of new/enlarging T2 lesions and new T1 hypointense lesions occurred before week 24 and significantly declined thereafter. 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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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 | 0.003 |
| Insufficient payload (model declined to judge) | 0.002 | 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".