Patients Who Switched from SC IFNB-1a to Alemtuzumab in the CARE-MS I Extension Study Show Durable Improvements in Clinical Outcomes (P3.104)
Bibliographic record
Abstract
OBJECTIVE: Examine clinical efficacy and safety of alemtuzumab over 3 years after switching from SC IFNB-1a in the CARE-MS I extension study (NCT00930553). BACKGROUND: In CARE-MS I (NCT00530348), treatment-naive patients with active relapsing-remitting MS demonstrated significantly reduced annualized relapse rate (ARR) with alemtuzumab versus SC IFNB-1a over 2 years. Efficacy in core study alemtuzumab-treated patients was durable through 5 years, with no additional treatment for most patients for 4 years. DESIGN/METHODS: Patients treated with SC IFNB-1a in 2-year core study discontinued treatment and received 2 alemtuzumab courses at Months 0 and 12 of extension, then as-needed retreatment for relapse or radiological activity. No evidence of disease activity (NEDA): absence of clinical disease activity (CDA; relapses and 6-month confirmed disability progression [≥1-point Expanded Disability Status Scale (EDSS) increase]) and new gadolinium-enhancing T1 and new/enlarging T2 lesions. RESULTS: Extension study enrolled 144 (83[percnt]) core study SC IFNB-1a-treated patients; 81[percnt] received no alemtuzumab retreatment since Month 12 after switching. ARR decreased after switching by 72[percnt] in Years 0-3 (0.11) versus core study (0.39). In Years 0-3 after switching, 86[percnt] of patients were free from 6-month confirmed disability progression, 81[percnt] had stable or improved EDSS, 18[percnt] achieved 6-month sustained reduction in disability (≥1-point EDSS decrease), and 66[percnt] had no evidence of CDA. NEDA was achieved by 70[percnt], 72[percnt], and 59[percnt] of patients in Years 1, 2, and 3, respectively, and 38[percnt] over Years 1-3 after switching. Safety profile 3 years after switching was consistent with core study alemtuzumab arm. CONCLUSIONS: Durable efficacy with low retreatment rates through 3 years after switching to alemtuzumab supports sustained effects on disease activity, as also demonstrated in core study alemtuzumab-treated patients during extension. Safety after switching was consistent with previously reported alemtuzumab experience. 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 | 0.001 | 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 | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".