Patients Who Discontinued SC IFNB-1a and Switched to Alemtuzumab in the CARE-MS II Extension Study Show Durable Reduction in New Lesion Activity (P3.025)
Bibliographic record
Abstract
OBJECTIVE: Examine alemtuzumab’s effect on MRI outcomes over 3 years after switching from SC IFNB-1a to alemtuzumab in CARE-MS II extension study (NCT00930553). BACKGROUND: In CARE-MS II (NCT00548405), active relapsing-remitting MS patients who had an inadequate response (≥1 relapse) to prior therapy at baseline demonstrated improved MRI outcomes versus SC IFNB-1a over 2 years. Efficacy was durable through 5 years in core study alemtuzumab-treated patients, 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 extension Months 0 and 12, then as-needed alemtuzumab retreatment for relapse or radiological activity. Annual MRI scans assessed gadolinium (Gd)-enhancing T1, new/enlarging T2 hyperintense, and new T1 hypointense lesions. MRI disease activity was defined as new Gd-enhancing T1 and new/enlarging T2 lesions. RESULTS: 146 (83[percnt]) core study SC IFNB-1a-treated patients entered the extension; 84[percnt] received no alemtuzumab retreatment since Month 12 after switching. Proportion of patients lesion-free was increased at Year 3 after switching to alemtuzumab compared with core study Year 2 on SC IFNB-1a (Gd-enhancing: 86.2[percnt] vs 77.6[percnt]; T2: 72.1[percnt] vs 47.7[percnt]; T1: 84.5[percnt] vs 73.8[percnt]). Most patients had no evidence of MRI disease activity in Years 1, 2, and 3 (64.2[percnt], 80.9[percnt], 72.1[percnt]) and over Years 1-3 (52.0[percnt]) after switching. No evidence of disease activity was seen in 51.1[percnt], 65.7[percnt], and 63.6[percnt] of patients in Years 1, 2 and 3, and in 31.7[percnt] over Years 1-3 after switching. CONCLUSIONS: These findings support the benefit of switching from SC IFNB-1a to alemtuzumab. Durable improvements on MRI outcomes with low retreatment rates after switching to alemtuzumab further support the sustained effect on disease activity observed in core study alemtuzumab patients over 5 years. 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 | 0.001 |
| 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 | 0.000 | 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".