Patients Who Had Highly Active RRMS and an Inadequate Response to Prior Therapy Demonstrated Durable Efficacy with Alemtuzumab: 5-Year Follow-Up of the CARE-MS II Study (P6.164)
Bibliographic record
Abstract
OBJECTIVE: Examine alemtuzumab efficacy in patients with highly active relapsing-remitting MS (RRMS) and inadequate response (≥1 relapse) to prior therapy at baseline. BACKGROUND: In CARE-MS II (NCT00548405), alemtuzumab significantly reduced clinical and MRI disease activity versus SC IFNB-1a over 2 years in the highly active subgroup. Efficacy was durable through 4 years, despite most receiving no therapy since Month 12. DESIGN/METHODS: Patients received alemtuzumab courses at baseline and Month 12 in the core study. Patients could enter extension (NCT00930553), with as-needed retreatment for relapse or radiological activity. Highly active disease: ≥2 relapses in year before randomization; ≥1 baseline gadolinium-enhancing lesion. No evidence of disease activity (NEDA): absence of MRI (new gadolinium-enhancing and new/enlarging T2 lesions) and clinical (6-month confirmed disability progression or relapse) activity. Brain volume was measured by brain parenchymal fraction. RESULTS: The extension enrolled 92/103 (89[percnt]) alemtuzumab-treated CARE-MS II patients who were highly active at core study baseline. Through 5 years, 62[percnt] received only the initial 2 courses; 97[percnt] did not receive another disease-modifying therapy. In the extension (Years 3-5), annualized relapse rate was 0.18, 54[percnt] of patients had no evidence of clinical disease activity, and 47[percnt] had no evidence of MRI disease activity. NEDA was observed in 54[percnt], 52[percnt], and 54[percnt] of patients in Years 3, 4, and 5, respectively, and 26[percnt] had NEDA sustained over Years 3-5. Annual median percent brain parenchymal fraction change in Year 5 was -0.13[percnt]. CONCLUSIONS: Efficacy was durable through Year 5 in patients with highly active disease and an inadequate response to prior therapy, despite most not receiving treatment since Month 12. These results suggest that alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continued treatment for highly active 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 | 0.002 | 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 | 0.001 | 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".