Peter Goadsby, MD discusses the efficacy, safety, & tolerability of the CGRP inhibitor erenumab in a phase III trial of participants with episodic migraine.
Primary results of the STRIVE trial indicate erenumab (AMG 334) significantly reduced migraine frequency as well as migraine medication use and the impact of migraine on physical impairment and everyday activities in participants with episodic migraine.
Erenumab is a fully monoclonal antibody that inhibits the calcitonin gene-related peptide (CGRP) receptor. “The significance of STRIVE is that this is a large, well powered, phase III study which establishes that blocking the CGRP pathway. . .prevents migraine. We have never had a migraine-specific preventive therapy. Now we are going to have a mechanism-targeted, disorder-specific therapy. . .to prevent this highly disabling problem,” said Peter Goadsby, MD, PhD, UCSF Medical Center, San Francisco, CA.
Participants of the multinational, double-blind, phase III trial were randomized 1:1:1 to subcutaneous monthly placebo or erenumab 70mg or 140mg for 24 weeks. Subjects were adults with episodic migraine (n=955) who experienced a mean of 8.3 monthly migraine days. Goadsby and colleagues collected data to determine change from baseline in mean monthly migraine days over weeks 13-24 (primary endpoint). The secondary endpoints were ≥50% reduction in monthly migraine days, change in mean acute migraine medications, and change in mean Physical Impairment (PI) and Impact on Everyday Activities (EA) scores (as measured by the Migraine Physical Function Impact Diary [MPFID]).
Reduction in monthly migraine days
On 70mg – 3.2 days
On 140mg – 3.7 days
On placebo – 1.8 days
≥50% reduction in monthly migraine days
On 70mg – 43%
On 140mg – 50%
On placebo – 27%
Reduction in monthly acute migraine-specific medication days
On 70mg – 1.1 days
On 140mg – 1.6 days
On placebo – 0.2 days
Improved PI scores
On 70mg – -4.2 points
On 140mg – -4.8 points
On placebo – -2.4 points
Improved EA scores
On 70mg – -5.5 points
On 140mg – -5.9 points
On placebo – -3.3 points
Subjects most frequently reported nasopharyngitis, upper respiratory tract infection, and sinusitis, but the safety and tolerability profile of erenumab was similar to placebo.
In conclusion, participants taking erenumab 70mg and 140mg experienced significant improvements in both primary and secondary endpoints, with numerically greater efficacy seen in those on the 140mg dose.
Goadsby P, et al. 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. From materials presented at AAN Annual Meeting, Boston, MA. Clinical Trials Plenary Session. April 25, 2017.