Effect of Teriflunomide on Relapses Associated with Disability Worsening: Results from the TEMSO and TOWER Studies (P3.079)
Bibliographic record
Abstract
Objective: To assess the effect of teriflunomide 14 mg on relapses associated with confirmed disability worsening in a post hoc analysis of pooled TEMSO and TOWER data. Background: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting MS. In 2 pivotal phase 3 clinical trials in patients with relapsing forms of MS (TEMSO, NCT00134563 and TOWER, NCT00751881), teriflunomide 14 mg significantly reduced risk of disability progression confirmed for 12 weeks by 29.8[percnt] (P=0.028, TEMSO) and 31.5[percnt] (P=0.044, TOWER), and significantly reduced annualized relapse rate by 31.5[percnt] (P<0.001, TEMSO) and 36.3[percnt] (P<0.001, TOWER) vs placebo. Design/Methods: Analysis was performed on the pooled dataset from TEMSO and TOWER, and included 728 patients in the 14-mg group and 751 patients in the placebo group. In the subgroup of patients who relapsed, treatment group comparisons were made using a logistic regression model for those patients who had disability progression starting at any time after a relapse and confirmed at a scheduled visit at least 12 weeks later. Results: In the pooled dataset, 36.1[percnt] (n=263) of patients treated with teriflunomide 14 mg had relapses, vs 49.3[percnt] (n=370) in the placebo group. Of these patients, 22[percnt] (n=58) in the 14-mg group vs 29[percnt] (n=106) in the placebo group had disability progression (odds ratio 1.455; 95[percnt] CI: 1.002, 2.111; P=0.0486). In the majority of patients who experienced 12-week confirmed disability progression any time after a relapse, progression started within 30 days of relapse onset. Approximately 90[percnt] of patients in both treatment groups who remained free of relapses also remained free from 12-week confirmed disability progression. Conclusions: Treatment with teriflunomide resulted in significant reduction in the proportion of patients experiencing disability progression following relapse in the pooled TEMSO and TOWER dataset vs placebo. 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 | 0.011 | 0.010 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.012 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| 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".