Alemtuzumab Slows Brain Volume Loss Over 4 Years Despite Most Relapsing-Remitting Multiple Sclerosis Patients Not Receiving Treatment for 3 Years (P7.263)
Bibliographic record
Abstract
OBJECTIVE: Examine alemtuzumab’s effect on brain volume change over 4 years in patients who participated in the CARE-MS studies and ongoing extension. BACKGROUND: In 2 phase 3, head-to-head trials in active relapsing-remitting multiple sclerosis (RRMS) patients, alemtuzumab had superior efficacy versus subcutaneous interferon beta-1a (SC IFNB-1a), including a 42[percnt] greater reduction in brain volume loss than SC IFNB-1a over 2 years in treatment-naive patients (CARE-MS I; NCT00530348) and 24[percnt] greater reduction than SC IFNB-1a in patients who relapsed on prior therapy (CARE-MS II; NCT00548405). DESIGN/METHODS: Core study patients randomized to alemtuzumab received 12 mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later. In the extension (NCT00930553), alemtuzumab-treated patients could receive as-needed retreatment 蠅1 year after previous course. Magnetic resonance imaging scans were acquired at baseline and yearly thereafter. Brain volume loss was measured by brain parenchymal fraction (BPF) change. RESULTS: 349 (95.1[percnt]) CARE-MS I and 393 (92.9[percnt]) CARE-MS II alemtuzumab patients entered the extension phase; data are available through 4 years from first treatment with ongoing follow-up. Among CARE-MS I patients, 20.9[percnt] received 1 and 4.6[percnt] received 2 additional courses during the extension. Median rate of BPF loss decreased progressively over time in CARE-MS I (Year 1: -0.59[percnt], Year 2: -0.25[percnt], Year 3: -0.19[percnt], Year 4: -0.15[percnt]). Among CARE-MS II patients, 24[percnt] received 1 and 7[percnt] received 2 additional courses during the extension. Median rate of BPF loss progressively slowed over 3 years in CARE-MS II and remained low in Year 4 (Year 1: -0.48[percnt], Year 2: -0.22[percnt], Year 3: -0.10[percnt], Year 4: -0.19[percnt]). CONCLUSIONS: Slowing of brain volume loss with alemtuzumab was maintained over 4 years despite most patients receiving last treatment 3 years prior. These findings support alemtuzumab’s durable efficacy in RRMS. 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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| 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 | 0.001 |
| 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".