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- Title
Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions.
- Authors
Ashina, Messoud; Kudrow, David; Reuter, Uwe; Dolezil, David; Silberstein, Stephen; Tepper, Stewart J.; Fei Xue; Picard, Hernan; Feng Zhang; Wang, Andrea; Yanchen Zhou; Hong, Frank; Klatt, Jan; Mikol, Daniel D.; Xue, Fei; Zhang, Feng; Zhou, Yanchen
- Abstract
<bold>Background: </bold>Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date.<bold>Methods: </bold>This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies.<bold>Results: </bold>In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions.<bold>Conclusions: </bold>This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.
- Subjects
CALCITONIN gene-related peptide; PEPTIDE receptors; SPASMS; MIGRAINE; WNT genes; ERENUMAB
- Publication
Cephalalgia, 2019, Vol 39, Issue 14, p1799
- ISSN
0333-1024
- Publication type
journal article
- DOI
10.1177/0333102419888222