P.032 Long-term safety and tolerability of eptinezumab in patients with chronic migraine: A 2-year, open-label, phase 3 trial
Bibliographic record
Abstract
Background: Eptinezumab is approved in the US for the preventive treatment of migraine and was well tolerated in double-blind, placebo-controlled studies in patients with episodic and chronic migraine (CM). The PREVAIL study evaluated the long-term safety, immunogenicity, and impact on patient-reported outcomes of repeat doses of eptinezumab in patients with CM. Methods: PREVAIL was an open-label, phase 3 trial comprising two 48-week treatment phases. Adults with CM received eptinezumab 300 mg by 30-minute IV every 12 weeks for ≤8 doses, with patients followed up to week 104. Results: 128 adults (mean age, 41.5y) with CM were treated. Over 2 years, the most frequently reported treatment-emergent adverse events were nasopharyngitis (14.1%), upper respiratory tract infection (7.8%), sinusitis (7.8%), influenza (6.3%), bronchitis (5.5%), and migraine (5.5%). Study-drug discontinuation due to adverse events was 6.3%. Anti-eptinezumab antibody incidence peaked at week 24 and declined despite continued dosing, to nondetectable levels at week 104. Patient-reported outcomes were improved at first assessment (week 4) and generally sustained through week 104. Conclusions: In adults with CM, eptinezumab 300 mg demonstrated a favorable safety profile, limited long-term immunogenicity, early and sustained reductions in migraine-related burden, and improvements in health-related quality of life over 2 years.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 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".