Efficacy of Teriflunomide in Early-Stage MS: Reanalysis of the TOPIC Study Using 2010 McDonald Diagnostic Criteria (P7.274)
Bibliographic record
Abstract
OBJECTIVE: To reanalyze TOPIC study outcomes applying 2010 McDonald diagnostic criteria. BACKGROUND: TOPIC (NCT00622700), a phase 3 study conducted from 2008-2012, evaluated the efficacy and safety of teriflunomide in patients with first clinical episode suggestive of MS. Primary and key secondary endpoints in TOPIC were met: teriflunomide 14mg reduced the risk of relapse determining conversion to clinically definite MS (CDMS) vs placebo by 43[percnt] (P=0.0087) and of a new clinical relapse or magnetic resonance imaging (MRI) lesion by 35[percnt] (P=0.0003). The 7mg dose was also superior to placebo, with a smaller effect. The 2010 revisions to the McDonald diagnostic criteria allow for earlier diagnosis of MS at the first clinical episode in some patients. DESIGN/METHODS: Patients with clinically isolated syndrome (CIS; n=614) were treated with teriflunomide 14mg, 7mg, or placebo for up to 108 weeks. The 2010 revised criteria were applied retrospectively; patients were grouped according to baseline disease characteristics meeting 2010 criteria, not meeting 2010 criteria, or unclassifiable (insufficient information). Time to new clinical relapse or MRI lesion was analyzed for patients not meeting 2010 criteria. Using these 3 groups, subgroup analyses were performed for primary and key secondary endpoints. RESULTS: For patients not meeting 2010 criteria (n=245), probability of new clinical relapse or MRI lesion at 108 weeks was 54.1[percnt] (teriflunomide 14mg), 63.0[percnt] (teriflunomide 7mg), and 74.4[percnt] (placebo). Teriflunomide treatment reduced the probability of conversion to CDMS by 39.1[percnt] (14mg, P=0.0222) or 38.3[percnt] (7mg, P=0.0265) vs placebo. There was no evidence of differential treatment effect across the 3 subgroups for the primary and key secondary efficacy endpoints (P>0.1 for all treatment-by-subgroup interactions). CONCLUSIONS: This analysis shows the efficacy of teriflunomide for the treatment of CIS according to 2010 McDonald criteria and confirms the consistency of treatment effect using various endpoints/diagnostic criteria. 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 | 0.013 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".