Long-term follow-up of patients with a first clinical demyelinating event (clinically isolated syndrome) who received cladribine tablets in CLASSIC-MS: Findings for the ORACLE-MS cohort
Bibliographic record
Abstract
BACKGROUND: CLASSIC-MS explored long-term outcomes of patients treated with cladribine tablets. OBJECTIVE: Assess long-term efficacy in patients previously enrolled in ORACLE-MS, a Phase III parent trial. METHODS: ORACLE-MS included patients with a first clinical demyelinating event (FCDE or clinically isolated syndrome) who received ⩾1 course of cladribine tablets or placebo. With a median follow-up time of 9.5 years, CLASSIC-MS assessed conversion rates to clinically definite multiple sclerosis (CDMS), time-to-conversion, relapse rates, long-term mobility/disability status and subsequent disease-modifying therapy (DMT) use. RESULTS: Of 227 patients from the ORACLE-MS cohort of 616, 68.7% were exposed to cladribine tablets and 31.3% were never exposed. Of the exposed patients at risk, 51.5% converted to CDMS with a median conversion time of 8.4 (95% confidence interval (CI): 5.4-not estimable) years, versus 80.6%, median time 0.8 (95% CI: 0.3-2.4) years, for never exposed. Exposed patients were less likely to be using a wheelchair or ambulatory device or receive subsequent DMTs, and 53.2% were relapse-free versus 28.2% never exposed. CONCLUSIONS: Proportionally, more FCDE patients exposed to cladribine tablets experienced delayed conversion to CDMS and fewer relapses and were less likely to use a wheelchair or ambulatory device than never-exposed patients, at 9.5 years (median).
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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) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".