Teriflunomide Significantly Increased Time to First Relapse in TEMSO, TOWER and TOPIC (P7.279)
Bibliographic record
Abstract
OBJECTIVE: To report time to first relapse data from phase 3, placebo-controlled trials, as delaying on-treatment relapse is an important indicator of response to therapy. BACKGROUND: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting MS. In TEMSO and TOWER, teriflunomide 14mg significantly reduced both annualized relapse rate (ARR) and disability progression versus placebo; teriflunomide 7mg reduced ARR. In TOPIC, teriflunomide significantly reduced risk of converting to clinically definite MS. DESIGN/METHODS: Patients with relapsing MS (TEMSO, NCT00134563, n=1088; TOWER, NCT00751881, n=1169) or first clinical episode suggestive of MS (TOPIC, NCT00622700, n=618) were randomized 1:1:1 to teriflunomide 14mg, 7mg, or placebo. Treatment duration was 108 weeks (TEMSO), ≤108 weeks (TOPIC), or variable (TOWER; 48-152 weeks). Time to first relapse data were derived from Kaplan-Meier estimates; significance versus placebo was assessed with a log-rank test. RESULTS: Teriflunomide increased time to first relapse compared with placebo in all three studies (25[percnt] quartile [<50[percnt] patients experienced an event], TEMSO: placebo 146 days, 14mg 218 days [P=0.0030], 7mg 240 days [P=0.0104]; TOWER: placebo 188 days, 14mg 369 days [P<0.0001], 7mg 272 days [P=0.0016]; TOPIC: placebo 317 days, 14mg 609 days [P=0.0333]; 7mg 636 days [P=0.0388]). Correspondingly, teriflunomide reduced risk of relapse, compared with placebo (patients relapse-free at Week 108, TEMSO: placebo 45.6[percnt]; 14mg 56.5[percnt], hazard ratio [HR] 0.719 [0.577, 0.895]; 7mg 53.7[percnt] HR 0.756 [0.611, 0.937]; TOWER: placebo 46.8[percnt]; 14mg 57.1[percnt], HR 0.631 [0.502, 0.794]; 7mg 58.2[percnt], HR 0.698 [0.562, 0.868]; TOPIC: placebo 61.7[percnt]; 14mg 72.2[percnt], HR 0.660 [0.447, 0.976]; 7mg 70.5[percnt], HR 0.645 [0.433, 0.960]). Both teriflunomide doses showed similar, manageable safety profiles across the studies. CONCLUSIONS: In all three studies, teriflunomide delayed occurrence of relapse versus placebo. These data demonstrate the benefit of teriflunomide on relapses across a range of relapsing MS patient populations. 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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
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".