Early vs Delayed Treatment with Teriflunomide 14 mg Results in Reduced Risk of Disability Progression in Patients with MS (P3.021)
Bibliographic record
Abstract
Objective: To investigate effects of early vs delayed treatment initiation with teriflunomide 14 mg on disability progression, using data from TOWER (NCT00751881) and its extension. Background: TOWER, a randomized, placebo-controlled study of teriflunomide in patients with relapsing MS (RMS), demonstrated a 31.5[percnt] reduction (P=0.0442) in risk of disability progression confirmed for ≥12 weeks for teriflunomide 14 mg vs placebo. Patients completing the core TOWER study could enter its extension; patients receiving teriflunomide 14 mg continued treatment (early treatment) while placebo-treated patients switched to teriflunomide 14 mg (delayed treatment). Methods: In TOWER, patients with RMS were randomized 1:1:1 to receive placebo or teriflunomide 14 mg or 7 mg, and treatment lasted ≥48 weeks. In the extension (not powered a priori to compare early vs delayed treatment), all patients received teriflunomide 14 mg. We compared risk of disability progression confirmed for ≥12 weeks for early vs delayed treatment, using a cutoff date of July 31, 2014 (up to 5.5 years' total study treatment). Results: Of 750 patients entering the extension, 232 continued with teriflunomide 14 mg, and 253 switched from placebo to teriflunomide 14 mg. The percentage of patients with disability progression confirmed for ≥12 weeks was consistently lower in the early vs delayed treatment group. During the core and extension studies, an estimated 26.7[percnt] and 30.2[percnt] of patients experienced disability progression confirmed for ≥12 weeks in the early and delayed treatment groups, respectively. The overall reduction in risk of disability progression confirmed for ≥12 weeks for early vs delayed treatment was 27.6[percnt] (95[percnt] confidence interval: 0.1, 47.5; P=0.0495). Conclusions: We observed a significant reduction in risk of disability progression in patients given early vs delayed treatment with teriflunomide 14 mg. This highlights the benefit of teriflunomide for reducing disability progression in patients with MS. Study supported by: Genzyme, a Sanofi company.
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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 | 0.002 | 0.002 |
| 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 | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".