Treatment-Naive Patients with Active RRMS Demonstrate Durable Improvements in Relapse and Disability Following Treatment with Alemtuzumab: 5-Year Follow-Up of the CARE-MS I Study (S51.004)
Bibliographic record
Abstract
Objective: To examine 5-year clinical efficacy and safety in CARE-MS I alemtuzumab-treated patients. Background: In CARE-MS I (NCT00530348), patients who were treatment-naive at baseline with active relapsing-remitting MS (RRMS) showed significantly reduced annualized relapse rate (ARR) with alemtuzumab versus SC IFNB-1a over 2 years. Efficacy was durable through 4 years. Design/Methods: In the CARE-MS I core study, alemtuzumab patients received 2 annual treatment courses at Months 0 and 12. Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or radiological activity. Endpoints included ARR, 6-month confirmed disability progression (≥1-point Expanded Disability Status Scale [EDSS] increase [≥1.5-point if baseline EDSS=0]), 6-month sustained reduction in preexisting disability (SRD; ≥1-point EDSS decrease [baseline score ≥2.0]), and no evidence of clinical disease activity (absence of relapse and 6-month disability progression). Results: 349 (95[percnt]) alemtuzumab-treated patients completing CARE-MS I enrolled in the extension. Through 5 years, 96[percnt] remained on study, 68[percnt] received no alemtuzumab since the initial 2 core study courses, and 2[percnt] received another disease-modifying therapy. Low ARR (0.16) was maintained over Years 3-5. Through Years 0-5, 80[percnt] of patients were free from 6-month confirmed disability progression, 82[percnt] had stable or improved EDSS, and 33[percnt] achieved 6-month SRD. Most patients (65[percnt]) had no evidence of clinical disease activity over Years 3-5. Incidences of infusion-associated reactions and infections during the extension were reduced versus core study; serious adverse event (AE) incidence was low. Thyroid AE incidence peaked at Year 3 and subsequently declined. Conclusions: Alemtuzumab demonstrated durable improvements in relapse and disability 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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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".