Interferon β-1a SC tiw Reduces Mild to Moderate and Moderate to Severe Relapses and Disease Activity over 1 Year in Patients with Relapsing MS: Post Hoc Analyses of PRISMS Data (P3.036)
Bibliographic record
Abstract
Objective: Examine how relapse severity affects relapse-free and no evidence of disease activity (NEDA) outcomes in patients treated with interferon (IFN) β-1a subcutaneously (SC) 3x/week. Background: In PRISMS-2, more patients treated with IFN β-1a SC versus placebo were relapse free and free of moderate-severe relapse at Year (Y) 2. The 1-year effect of IFN β-1a SC on relapse severity and disease activity remains to be characterized. Methods: Patients with relapsing MS were randomized to IFN β-1a 44 (n=184) or 22 μg (n=189) SC or placebo (n=187). Clinic visits were requested ≥7 days after relapse for Scripps neurologic rating scale severity assessments (decrease of 0-7, 8-14, or ≥15 points for mild, moderate, or severe, respectively). Exploratory analyses determined proportions of patients free from Scripps-assessed mild-to-severe, moderate-to-severe, and severe relapses. Patients were assessed over Y1 for NEDA status (no EDSS progression [increase ≥1 or ≥0.5 points from baseline <6 or ≥6, respectively, confirmed 3 months later] or active T2 lesions on Months 6 and 12 scans, with freedom from mild-to-severe, moderate-to-severe, or severe relapses). Results: More patients treated with IFN β-1a 44 or 22 μg SC were free from mild-to-severe (p<0.001) and moderate-to-severe (p≤0.016) relapses, versus placebo. Few patients (n=31, all groups) had severe relapses; no significant difference in freedom from severe relapses was observed between groups. More patients treated with IFN β-1a 44 or 22 μg SC had NEDA over Y1, versus placebo, irrespective of whether only mild-to-severe (p≤0.002), moderate-to-severe (p≤0.001), or severe relapses (p<0.001) were included. Conclusions: IFN β-1a SC treatment was associated with significantly more patients having NEDA, irrespective of relapse severity, and being free from mild-to-severe or moderate-to-severe relapses, over Y1 compared with placebo. Study supported by: EMD Serono, Inc., Rockland, MA, USA (a business of Merck KGaA, Darmstadt, Germany); Pfizer Inc, New York, NY, USA.
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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 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| 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 | 0.001 |
| 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".