Incidence and Timing of Thyroid Adverse Events in Patients with RRMS Treated with Alemtuzumab through 5 Years of the CARE-MS Studies (P2.086)
Bibliographic record
Abstract
OBJECTIVE: To summarize 5-year incidence and timing of thyroid adverse events following alemtuzumab treatment in the ongoing CARE-MS extension study. BACKGROUND: In the phase 3 CARE-MS studies, patients with active relapsing-remitting MS showed greater improvements in efficacy outcomes with alemtuzumab versus SC IFNB-1a over 2 years; efficacy was durable through 5 years in the extension study. Alemtuzumab’s consistent safety profile across the clinical trial program includes an identified risk of predominantly nonserious autoimmune thyroid disorders. DESIGN/METHODS: In the 2-year CARE-MS I and II (NCT00530348; NCT00548405) core studies, alemtuzumab-treated patients received 2 annual courses at Months 0 and 12. Patients could enter the extension study (NCT00930553) for ongoing follow-up and as-needed retreatment for relapse or radiological activity. As part of a comprehensive monitoring program, thyroid function testing was performed at baseline and quarterly thereafter. Thyroid monitoring is recommended for 4 years following last dose of alemtuzumab. RESULTS: During Years 0-5, thyroid events were reported in 39[percnt] (317/811) of patients; 4.4[percnt] had serious thyroid events. Most thyroid events were mild or moderate in severity. The proportion of patients with thyroid events peaked at Year 3 and subsequently declined (Year 1: 5.7[percnt]; Year 2: 10.7[percnt]; Year 3: 20.9[percnt]; Year 4: 12.6[percnt]; Year 5: 10.0[percnt]). No thyroid events resulted in study discontinuation. Most events were managed with first-line, conventional therapy; 3.2[percnt] of patients underwent thyroidectomy. CONCLUSIONS: The annual incidence of thyroid events following alemtuzumab treatment is consistent with previous reports, peaking in Year 3 and declining thereafter. Ongoing patient education and laboratory monitoring continue to enable timely detection and treatment of alemtuzumab-associated thyroid events. STUDY SUPPORTED BY: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".