Durable Effect of Alemtuzumab on MRI Activity in Treatment-Naive Active Relapsing-Remitting Multiple Sclerosis Patients: 4-Year Follow-up of CARE-MS I (P7.246)
Bibliographic record
Abstract
OBJECTIVE: Examine the effect of alemtuzumab on 4-year magnetic resonance imaging (MRI) outcomes in CARE-MS I patients who entered an ongoing extension study. BACKGROUND: In the CARE-MS I trial (NCT00530348) in treatment-naive patients with active relapsing-remitting multiple sclerosis (RRMS), alemtuzumab had superior efficacy versus subcutaneous interferon beta-1a, including a reduction in MRI lesion activity and brain volume loss over 2 years. 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 study (NCT00930553), alemtuzumab-treated patients could receive as-needed retreatment 蠅1 year after the previous course. MRI scans were acquired at baseline and yearly thereafter. MRI outcomes included gadolinium (Gd)-enhancing, new/enlarging T2 hyperintense and new T1 hypointense lesion activity, and MRI activity (absence of Gd-enhancing and new/enlarging T2 lesions). RESULTS: 349 (95.1[percnt]) CARE-MS I alemtuzumab-treated patients entered the extension; data are available through 4 years from first treatment, and follow-up is ongoing. Through 4 years, 73.4[percnt] of patients received only the initial 2 courses of treatment, 20.9[percnt] received 1 additional course, and 4.6[percnt] received 2 additional courses. In Year 3 and Year 4, the proportions of patients free of Gd-enhancing (90.2[percnt] and 87.2[percnt]), new/enlarging T2 (72.3[percnt] and 70.5[percnt]) or new T1 lesions (89.2[percnt] and 85.4[percnt]) remained stable. Most patients were MRI activity-free at Year 3 (72.1[percnt]) and Year 4 (70.1[percnt]). CONCLUSIONS: The majority of alemtuzumab patients remained free of new lesions and MRI activity in Year 4 despite 73.4[percnt] of patients receiving their last treatment course 3 years prior. These data support the durable efficacy of alemtuzumab in this RRMS 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 | 0.000 | 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".