Efficacy of Cladribine Tablets in ORACLE Study Patients Who Retrospectively Met 2010 McDonald Multiple Sclerosis (MS) Criteria at Baseline (P3.035)
Bibliographic record
Abstract
Objective: To investigate the effects of cladribine tablets over 96 weeks on time to a next relapse or disability worsening, after applying the 2010 McDonald criteria to the ORACLE-MS patient cohort at baseline. Background: ORACLE-MS showed that cladribine 3.5 and 5.25 mg/kg decreases significantly the risk of conversion to clinically definite MS (a combined endpoint of next relapse or 3-month confirmed EDSS progression) compared with placebo, in patients with a first clinical demyelinating event. Methods: In ORACLE-MS, patients were randomized (1:1:1) to placebo or 1 of 2 cumulative doses of cladribine (3.5 or 5.25 mg/kg bodyweight). For the present analysis, the risk of next relapse or disability progression was determined in those patients who would have fulfilled the revised McDonald 2010 criteria for MS at baseline per retrospective review of MRI scans. Results: Of 616 patients in ORACLE-MS, 36.2[percnt] would have met the criteria for diagnosis of MS if the 2010 McDonald diagnostic criteria had been applied at baseline. In these patients, the risk of the combined endpoint of a next relapse or 3-month confirmed disability progression was significantly lower in patients treated with cladribine 3.5 mg/kg (n=68) than in placebo (N=72) recipients (HR 0.26, 95[percnt]CI 0.12-0.58; p=0.0009), consistent with a risk reduction of 74[percnt] relative to placebo. Risk of the combined endpoint was also lower in patients treated with cladribine 5.25 mg/kg (n=83); however, the difference vs. placebo was not significant (HR 0.63, 95[percnt]CI 0.34-1.16; p=0.1364). In the overall all-patient analysis of ORACLE-MS, the incidence of adverse events was similar across treatment groups. Conclusions: This retrospective analysis shows that in patients who met the 2010 McDonald MS criteria at baseline, the risk of further relapse/disability worsening was significantly reduced with cladribine 3.5 mg/kg vs. placebo. Study supported by: Merck KGaA Darmstadt, Germany
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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 | 0.001 |
| 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 | 0.000 | 0.000 |
| 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".