Predictive Value of 6-Month T2 and Enhancing Lesions Among Patients with RRMS Receiving Interferon β-1a Subcutaneously Thrice Weekly or Placebo: Post Hoc Analyses of PRISMS Data (P1.401)
Bibliographic record
Abstract
Objective: Assess whether early T2 and Gd+ lesions predict longer-term clinical outcomes in patients receiving interferon beta-1a (IFN β-1a) 44 μg subcutaneously (SC) 3x/week (tiw) or placebo/delayed treatment (DTx). Background: In PRISMS-2, IFN β-1a SC tiw demonstrated clinical/MRI benefits versus placebo at Year (Y)2. In a 2-year extension, outcomes favored patients continuing IFN β-1a 44 μg SC tiw (Rx44) versus placebo/DTx (switching from placebo to IFN β-1a 44 or 22 μg SC tiw at Y2). Methods: All patients (N=560) underwent T2-weighted scans 2x/year; an MRI subgroup (n=205) also underwent monthly T2 and Gd+ scans. Exploratory analysis examined whether active T2 (all patients) or Gd+ lesions (MRI cohort only) on the scan at Month 6 (M6) predicted relapse or disease progression (increase of ≥1 or ≥0.5 points from baseline EDSS ≤5.5 or ≥6, respectively, sustained for 3 months) at Y2/Y4. Results: Patients with (vs without) active T2 lesions at M6 were more likely to have relapsed at Y2 (89.1[percnt] vs 66.7[percnt]; p=0.0032) and Y4 (93.2[percnt] vs 76.9[percnt]; p=0.0067) in the placebo/DTx group, but not the Rx44 group. Active T2 lesion presence (vs absence) at M6 did not predict disability progression in either group; however, more placebo/DTx patients with ≥2 versus 0-1 active T2 lesions at M6 had disability progression at Y2 (47.9[percnt] vs 23.1[percnt]; p=0.0079) and Y4 (56.2[percnt] vs 33.8[percnt]; p=0.0246). Gd+ lesions (presence vs absence) at M6 did not predict progression or relapses at Y2 or Y4 in either group. Conclusions: Early active T2 lesions predicted worsened longer-term outcomes in the placebo/DTx group, but not the Rx44 group; Gd+ lesions at M6 did not for either group. These results have implications for evaluating on-treatment disease prognosis. 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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| 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".