Treatment-Naive Patients with Active RRMS Who Received Alemtuzumab Demonstrate Durable Suppression of New MRI Lesion Formation: 5-Year Follow-Up of the CARE-MS I Study (S51.002)
Bibliographic record
Abstract
Objective: Examine 5-year MRI lesion outcomes in CARE-MS I alemtuzumab-treated patients. Background: In CARE-MS I (NCT00530348), patients with active relapsing-remitting MS (RRMS) who were treatment-naive at baseline demonstrated improved efficacy outcomes with alemtuzumab versus SC IFNB-1a over 2 years, including a significantly greater proportion with no evidence of MRI disease activity. Efficacy was durable through 5 years. Design/Methods: Alemtuzumab-treated patients received 2 annual treatment courses in the core CARE-MS I study. Patients could enter an extension study (NCT00930553), with as-needed alemtuzumab retreatment for relapse or radiological activity; another disease-modifying therapy (DMT) could be provided at the investigator’s discretion. Baseline followed by annual MRI scans were assessed for gadolinium (Gd)-enhancing T1, new/enlarging T2 hyperintense and new T1 hypointense lesions. MRI disease activity was defined as new Gd-enhancing T1 or new/enlarging T2 lesions. Results: 349 (95[percnt]) CARE-MS I alemtuzumab patients entered the extension study; of those, 96[percnt] remained on study, 68[percnt] received no alemtuzumab retreatment after the initial 2 courses at baseline and Month 12 of the core study, and 2[percnt] received another DMT. In each of Years 3, 4 and 5, the proportions of patients free of new lesions (Gd-enhancing: 87[percnt]-90[percnt]; T2: 70[percnt]-72[percnt]; T1: 85[percnt]-89[percnt]) were similar to those in Year 2. Over Years 3-5, 54[percnt] of patients had no evidence of MRI disease activity. No evidence of disease activity was achieved by 62[percnt], 60[percnt], and 62[percnt] of patients in Years 3, 4 and 5, respectively, and by 40[percnt] over Years 3-5. Conclusions: Durable improvements on MRI outcomes were observed over 5 years, despite most patients not receiving alemtuzumab for 4 years. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continued treatment for RRMS patients. Study Supported By: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".