Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study
Language English Country England, Great Britain Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- Keywords
- Erenumab, chronic migraine, clinical trial of prophylactic migraine treatment, prior preventive treatment failure, prior prophylactic treatment failure,
- MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Antibodies, Monoclonal, Humanized MeSH
- Middle Aged MeSH
- Humans MeSH
- Migraine Disorders prevention & control MeSH
- Antibodies, Monoclonal therapeutic use MeSH
- Calcitonin Gene-Related Peptide antagonists & inhibitors MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- erenumab MeSH Browser
- Antibodies, Monoclonal, Humanized MeSH
- Antibodies, Monoclonal MeSH
- Calcitonin Gene-Related Peptide MeSH
Background Erenumab was effective and well tolerated in a pivotal clinical trial of chronic migraine. Here, we evaluated efficacy and safety of monthly erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s) (≥ 1, ≥ 2 prior failed medication categories) and in patients who had never failed. Methods Subgroup analyses evaluated change from baseline in monthly migraine days; achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days; and change in monthly acute migraine-specific medication days. Adverse events were evaluated for each subgroup. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days (primary endpoint) at Month 3 (treatment difference [95% CI], never failed subgroup: -2.2 [-4.1, -0.3] for 70 mg and -0.5 [-2.4, 1.5] for 140 mg; ≥ 1 prior failed medication categories subgroup: -2.5 [-3.8, -1.2], for 70 mg and -3.3 [-4.6, -2.1] for 140 mg; ≥ 2 prior failed medication categories subgroup: -2.7 [-4.2, -1.2], for 70 mg and -4.3 [-5.8, -2.8] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days. There were no new or unexpected safety issues. Conclusion Erenumab showed consistent efficacy in chronic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups.
Amgen Inc Thousand Oaks CA USA
Department of Neurology Charité Universitätsmedizin Berlin Berlin Germany
Geisel School of Medicine at Dartmouth Hanover NH USA
Headache Unit Neurology Department University Hospital Center of Montreal Montreal QC Canada
Nashville Neuroscience Group and Department of Neurology Vanderbilt University Nashville TN USA
Novartis Pharma AG Basel Switzerland
Prague Headache Center DADO MEDICAL s r o Prague Czech Republic
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