The trial primary outcome was change in the number of monthly migraine days.
A monthly subcutaneous injection of 70 mg erenumab may represent an effective prophylactic treatment for episodic migraine, as it was shown to reduce migraine frequency and the use of acute migraine-specific medications in a study published in Cephalalgia.
In this placebo-controlled randomized phase 3 study (ClinicalTrials.gov identifier: NCT02483585), investigators randomly assigned adult patients with episodic migraine to receive 70 mg erenumab (n=286) or placebo (n=291) for 3 months. The trial primary outcome was change in the number of monthly migraine days. Secondary outcomes were ≥50% reduction in monthly migraine days, changes in the number of days using migraine medication, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores as assessed by patient reports in the Migraine Physical Function Impact Diary.
A greater reduction in monthly migraine days was observed in participants receiving erenumab vs placebo (−2.9 days vs −1.8 days, respectively; least-squares mean [95% CI] treatment difference, −1.0 [−1.6, −0.5]; P <.001). In addition, a greater percentage of patients receiving erenumab experienced a ≥50% reduction in monthly migraine days compared with placebo (39.7% vs 29.5%, respectively; odds ratio [OR], 1.59; 95% CI, 1.12-2.27]; P =.010). A significant reduction in migraine-specific medication treatment days was observed in the erenumab vs placebo group (−1.2 vs −0.6 days, respectively; treatment difference −0.6; 95% CI, −1.0, −0.2]; P =.002).
At 3-month follow-up, the ≥5-point reduction rates in the Migraine Physical Function Impact Diary – Physical Impairment (erenumab, 33.0% vs placebo, 27.1%; OR, 1.33; 95% CI, 0.92-1.90; P =.13) and the Migraine Physical Function Impact Diary – Everyday Activities (erenumab, 40.4% vs placebo, 35.8%; OR: 1.22 [95% CI: 0.87, 1.71]; P =.26) were comparable in both groups. Adverse event incidence during the treatment period was also comparable in both groups (erenumab, 48.1% vs placebo, 54.7%).
The 3-month study period was too short to identify long-term treatment effects in patients with episodic migraine. In addition, since this study population was comprised of mostly white women, the findings may be limited to that patient group.
“This phase 3 study provides evidence that once-monthly subcutaneous injection of erenumab is a potential new preventive therapy in patients with episodic migraine,” concluded the study authors.
Dodick DW, Ashina M, Brandes JL, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine [published online January 1, 2018]. Cephalalgia. doi:10.1177/0333102418759786O