12-Year Clinical Efficacy and Safety Data for Teriflunomide: Results from a Phase 2 Extension Study (P7.223)
Bibliographic record
Abstract
OBJECTIVE: To report long-term efficacy and safety data from patients treated with teriflunomide for ≤12 years. BACKGROUND: Teriflunomide is a once-daily oral immunomodulator for the treatment of relapsing-remitting MS. In phase 2 and 3 studies, teriflunomide demonstrated consistent efficacy with positive effects on relapse rates, risk of disability progression, and magnetic resonance imaging outcomes, with a manageable safety and tolerability profile. DESIGN/METHODS: In the core phase 2 study (NCT01487096), patients with relapsing MS (18-65 years; Expanded Disability Status Scale [EDSS] score ≤6; 蠅2 clinical relapses during the previous 3 years and 1 relapse in preceding year) were randomized (1:1:1) to teriflunomide 14mg or 7mg, or placebo. After completing the 36-week core study, patients could enter the long-term open-label extension (NCT00228163). In the extension, patients continued teriflunomide therapy and those previously treated with placebo were reallocated (1:1) to teriflunomide 14mg or 7mg. EDSS score was assessed every 24 weeks, and clinical relapses and safety reported throughout the study. RESULTS: Of 179 patients originally randomized, 147 entered the extension. Including treatment in core and extension studies, patients received teriflunomide for ≤576 weeks, with a cumulative duration of teriflunomide exposure of >990 patient-years (both treatment groups). During the study, annualized relapse rates remained low (both groups), and percentage of patients free from relapse during the extension was greater in the 14-mg (51.5[percnt]) versus the 7-mg group (39.5[percnt]). Patients had minimal increases in EDSS score following up to 528 weeks of treatment. No new/unexpected adverse events were identified following long-term teriflunomide treatment, and the safety and tolerability profile was consistent with other clinical studies. CONCLUSIONS: Relapse rates and change in EDSS score remained low in both groups following up to 12 years of teriflunomide treatment. No unexpected safety findings were associated with long-term teriflunomide treatment. 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 | 0.007 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.002 |
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".