Erenumab, a fully human monoclonal antibody targeting the canonical CGRP receptor, has demonstrated efficacy and safety in migraine prevention studies.

To assess the long-term efficacy and safety of erenumab over 52 weeks in patients with episodic migraine enrolled in the phase 3 STRIVE study (NCT02456740).

Patients were randomized (1:1:1; n=955) during the 24-week double-blind treatment phase (DBTP) of the STRIVE study to placebo, erenumab 70 mg, or erenumab 140 mg monthly for 24 weeks. At week 24 (active treatment phase [ATP] baseline), 845 patients were rerandomized (1:1) to erenumab 70 mg or 140 mg for the subsequent 28-week dose-blinded ATP. Assessments included monthly migraine days (MMD); monthly acute migraine-specific medication treatment days (MSMD); proportion of patients achieving a ≥50%,  ≥75%, and 100% reduction in MMD (responder rates: RR); and safety.

At week 52, patients receiving erenumab 70 mg (n=421) or 140 mg (n=424) during ATP showed –4.2 / –4.6 MMD changes from study baseline and –1.1/–1.8 MMD from ATP baseline, respectively.  For patients switching from placebo to 70 mg or 140 mg, change from ATP baseline to week 52 in MMD was –2.2 and –2.9, respectively. Improvements were also seen in MSMD. At the end of the study, 61.0% of patients on 70 mg and 64.9% of patients on 140-mg achieved a ≥50% RR; 38.5% of patients on 70 mg and 40.8% of patients on 140 mg achieved a ≥75% RR; 19.8% of patients on 70 mg and 21.2% of patients on 140 mg achieved 100% RR. Safety of erenumab in the ATP was similar to that observed in the DBTP and in prior studies.

Over 52 weeks, erenumab provided sustained efficacy in prevention of episodic migraine and a safety profile comparable to that observed in prior studies, with no new relevant safety findings.