No Evidence of Disease Activity for 4 Years Following 2 Courses of Alemtuzumab and No Further Treatment: Long-Term Responders from the CARE-MS II Study (P3.059)
Bibliographic record
Abstract
OBJECTIVE: Examine potential long-term responders to alemtuzumab by evaluating patients who had “no evidence of disease activity” (NEDA) after 2 alemtuzumab courses in core CARE-MS II study. BACKGROUND: In CARE-MS II (NCT00548405), active relapsing-remitting MS (RRMS) patients with inadequate response (≥1 relapse) to prior therapy at baseline demonstrated greater improvements in clinical and MRI outcomes with alemtuzumab versus SC IFNB-1a over 2 years. Efficacy was durable over 5 years in absence of retreatment for most patients. DESIGN/METHODS: Alemtuzumab patients received 2 alemtuzumab treatment courses at Months 0 and 12 in core study and could enter extension (NCT00930553), and receive as-needed alemtuzumab retreatment for relapse or radiological activity. Endpoints: proportion relapse-free, 6-month confirmed disability progression (≥1-point Expanded Disability Status Scale increase), clinical disease activity (CDA; ≥1 relapse or 6-month confirmed disability progression), MRI disease activity (new gadolinium-enhancing T1 and new/enlarging T2 hyperintense lesions), and NEDA (absence of CDA and MRI disease activity). RESULTS 393 (93[percnt]) CARE-MS II alemtuzumab-treated patients enrolled in extension; of these, 141 achieved NEDA in core study Year 2 (Months 12-24) and had no additional treatment for 4 years. In Years 2-5, 84.3[percnt] were relapse-free, 91.0[percnt] free from 6-month confirmed disability progression, 77.6[percnt] and 59.3[percnt], respectively, had sustained absence of CDA and MRI disease activity. Most patients (74.6[percnt], 74.8[percnt], 67.3[percnt]) achieved NEDA in Years 3, 4, and 5 of extension and almost half (48.2[percnt]) had sustained NEDA over Years 2-5 (Months 12-60). CONCLUSIONS: Of patients who achieved NEDA in Year 2 and received no further treatment following the initial 2 courses of alemtuzumab, nearly half maintained NEDA through Year 5. 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.
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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) | 0.001 | 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 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".