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BOSTON — Results from 2 phase 3 clinical trials presented at the American Headache Society (AHS) 56th Annual Scientific Meeting indicate that erenumab may represent a safe and efficacious prophylactic treatment for episodic migraine.1
Erenumab, also known as AMG 334, is a fully human monoclonal antibody raised against the Calcitonin Gene-Related Peptide (CGRP) receptor, which, along with CGRP, has been implicated in the pathogenesis of migraine.2
For the first double-blind and placebo-controlled trial dubbed STRIVE (Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention; ClinicalTrials.gov identifier: NCT02456740), a total of 955 patients with episodic migraine were enrolled in several countries and randomly assigned to receive erenumab (70 or 140 mg) or placebo for a period of 24 weeks.1
The study’s primary endpoint, mean monthly migraine days, was significantly reduced from baseline (8.3 days) for study participants in the 70- and 140-mg erenumab groups (−3.2 and −3.7 days, respectively; P <.001 for both), but not in the placebo group (−1.8 days). A study secondary endpoint, ≥50% reduction in monthly migraine days, was reported by 43% and 50% of patients administered 70 and 140 mg erenumab, respectively (P <.001 for both), but only by 27% of patients in the placebo group. Both doses of erenumab were also effective in reducing mean acute migraine-specific medication days (−1.1 and −1.6 days for 70 and 140 mg erenumab, respectively [P <.001 for both] vs −0.2 day for placebo), and in improving physical impairment scores (−4.2 and −4.8 points for 70 and 140 mg erenumab, respectively [P <.001] vs −2.4 points for placebo) and impact on everyday activity scores (−5.5 and −5.9 points for 70 and 140 mg erenumab, respectively [P <.001] vs −3.3 points for placebo), 2 other secondary endpoints of the study.
In addition, the drug was found to be well-tolerated, with minor adverse effects that included upper respiratory tract infection, nasopharyngitis, and sinusitis.
The investigators concluded that results from this trial indicate that both doses of erenumab “significantly reduced migraine frequency and use of migraine-specific medications, reducing migraine’s impact on physical impairment and everyday activities compared with placebo.” They added that “Numerically greater efficacy was observed for the 140 mg dose consistently across all endpoints.”
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- Goadsby P. Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab (AMG 334) in migraine prevention: primary results of the STRIVE trial. The American Headache Society 59th Annual Meeting; June 8-11, 2017; Boston, Massachusetts.
- Edvinsson L. The Trigeminovascular Pathway: Role of CGRP and CGRP Receptors in Migraine. Headache. 2017;57 Suppl 2:47-55.