Background: Novel therapeutic options with improved efficacy and safety profiles are needed for the prophylaxis of migraine. In recent years, the inhibition of calcitonin gene-related peptide (CGRP) signaling has attracted growing interest in the pharmacological research on migraine. Erenumab is the first fully human monoclonal antibody directed against the CGRP receptor to be approved for use in migraineurs.
Objective: To evaluate the efficacy and safety of erenumab as preventive treatment in patients with migraine using meta-analytical techniques.
Methods: Randomized, placebo-controlled, single- or double-blinded trials were identified through a systematic literature search (October week 4, 2018). Main outcomes included the changes from baseline in monthly migraine days (MMD) and monthly acute migraine-specific medication days (MSMD) at week 12, and the incidence of adverse events (AEs), severe AEs (SAEs) and treatment withdrawal due to AEs. Mean difference (MD) and risk ratio (RR) with 95% confidence intervals (95% CIs) were estimated.
Results: Across the five included trials, erenumab given as a subcutaneous injection at a monthly dosage of 70 mg and 140 mg was associated with a significantly greater reduction in baseline MMD (70 mg: MD - 1.3, 95% CI - 1.7 to - 1.0, p < 0.001; 140 mg: MD - 1.9, 95% CI - 2.3 to - 1.4, p < 0.001) and MSMD (70 mg: MD - 1.0, 95% CI - 1.6 to - 0.4, p < 0.001; 140 mg: MD - 1.8, 95% CI - 2.5 to - 1.1, p < 0.001) than placebo. There were no differences in the occurrence of AEs, SAEs, and drug withdrawal due to AEs between the erenumab and placebo groups.
Conclusions: Erenumab is an efficacious and well tolerated preventive treatment in adult patients with episodic and chronic migraine.