Durable Effect of Alemtuzumab on Clinical Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis Who Relapsed on Prior Therapy: 4-Year Follow-up of CARE-MS II (P7.276)
Bibliographic record
Abstract
OBJECTIVE: Examine alemtuzumab’s 4-year efficacy and safety in the CARE-MS II extension study. BACKGROUND: In the 2-year core study, alemtuzumab had superior clinical efficacy versus subcutaneous interferon beta-1a with manageable tolerability and safety in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy. Alemtuzumab’s efficacy was subsequently shown to be durable through 3 years. DESIGN/METHODS: In CARE-MS II (NCT00548405), patients received alemtuzumab 12 mg at baseline and month 12. In extension (NCT00930553), alemtuzumab-treated patients received as-needed alemtuzumab retreatments 蠅1 year apart. Endpoints included annualized relapse rate (ARR), improved/stable/worsened Expanded Disability Status Scale (EDSS) score (蠅0.5-point decrease [improvement] or 蠅0.5-point increase [worsening] from core baseline), sustained accumulation of disability (SAD; 蠅1-point EDSS increase over 蠅6 months [蠅1.5-point if baseline EDSS=0]), and sustained reduction in preexisting disability (SRD; 蠅1-point EDSS decrease from baseline over 蠅6 months [patients with baseline score 蠅2.0]). RESULTS: The extension study enrolled 393 (93[percnt]) CARE-MS II alemtuzumab-treated patients. Through 4 years, 68[percnt] received only the initial 2 treatment courses; 24[percnt] received 1 additional course; 7[percnt] received 2 additional courses. ARR was maintained from Year 3 (0.22) to Year 4 (0.23). From baseline to end of Year 4: 66[percnt] of patients had stable or improved EDSS scores; 76[percnt] of patients did not experience 6-month SAD; and 41[percnt] of patients achieved 6-month SRD. Incidences of infusion-associated reactions and infections were greatest after first treatment course. Thyroid adverse event incidence peaked at Year 3, then declined. CONCLUSIONS: Alemtuzumab’s efficacy was maintained over 4 years despite most patients not having received additional treatment over the previous 3 years. The safety profile during extension study was consistent with the core study; no unexpected adverse events occurred. These findings support the durable efficacy and favorable benefit-risk profile of alemtuzumab in this population. 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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 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".