Final Outcomes of the Teriflunomide Phase 2 Extension Study: 13 Years of Efficacy and Safety Results (P3.027)
Bibliographic record
Abstract
Objective: To report long-term efficacy and safety data from patients treated with teriflunomide for up to 13 years in a phase 2 extension study (NCT00228163). Background: Teriflunomide is a once-daily oral immunomodulator approved for relapsing-remitting MS. In phase 2 and 3 studies, teriflunomide demonstrated consistent efficacy on clinical and magnetic resonance imaging (MRI) outcomes, with a well-characterized safety and tolerability profile. Design/Methods: In the phase 2 study (NCT01487096), patients with relapsing MS were randomized (1:1:1) to once-daily placebo, teriflunomide 7mg, or 14mg. After completing the 36-week core study, patients could enter a long-term open-label extension in which patients receiving active therapy continued to receive teriflunomide, while patients previously treated with placebo were reallocated (1:1) to teriflunomide 7mg or 14mg. Results from the final analysis of the long-term extension (last patient visit, December 1, 2014) are presented. Results: A total of 147 patients entered the extension, which is now complete; including core and extension phases, patients received teriflunomide (7mg or 14mg) for up to 669 weeks, with a cumulative duration of exposure of 1136 patient-years. During the extension, annualized relapse rates remained low in all groups (0.188 and 0.256 for 14-mg and 7-mg groups, respectively), and proportion of relapse-free patients remained higher in those receiving teriflunomide 14mg in the extension (34/66, 51.5[percnt]) vs 7mg (32/81, 39.5[percnt]). Expanded Disability Status Scale (EDSS) scores were stable following up to 600 weeks of treatment during the extension. MRI disease activity continued to be low in teriflunomide-treated patients. No new/unexpected adverse events were identified, and the safety and tolerability profile was consistent with other teriflunomide clinical studies. Conclusions: Clinical and MRI disease activity remained low and EDSS scores remained stable for up to 13 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 | 0.008 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 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 | 0.001 | 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".