The humanized monoclonal antibody Galcanezumab ( Emgality ), which binds to calcitonin gene‐related peptide ( CGRP ), has been evaluated for migraine prevention.
The aim of the post‐hoc analyses was to describe the onset of effect of Galcanezumab for prevention of episodic migraine based on data from the phase 3 clinical program.
These analyses were derived from patients who participated in the randomized, double‐blind, placebo‐controlled phase 3 studies ( EVOLVE‐1 and EVOLVE‐2 ) that included patients aged 18‐65 years with a diagnosis of episodic migraine and a history of migraine headaches for 1 year.
A total of 1,773 ( 858 EVOLVE‐1, 915 EVOLVE‐2 ) patients were randomized and received either 120 mg or 240 mg Galcanezumab ( n=879 ) or placebo ( n=894 ).
Study drug was administered subcutaneously once per month for 6 months.
The patient population was predominately female ( 83.7% EVOLVE‐1, 85.4% EVOLVE‐2 ) and white ( 80.4% EVOLVE‐1, 70.3% EVOLVE‐2 ) with a mean age of approximately 41 years ( 40.7 years EVOLVE‐1, 41.9 years EVOLVE‐2 ).
On average, patients had been diagnosed with migraine approximately 20 years prior to study entry ( 20.1 years EVOLVE‐1, 20.6 years EVOLVE‐2 ), most patients experienced severe disability ( Migraine Disability Assessment total score: 33.2 EVOLVE‐1, 33.0 EVOLVE‐2 ); the approximate mean number of baseline monthly migraine headache days ( MHDs ) was 9 ( 9.1 days EVOLVE‐1 9.1 days EVOLVE‐2 ).
Patients in the 120‐mg group received a 240‐mg loading dose for the first month. Onset‐of‐effect analyses therefore evaluated the pooled Galcanezumab‐treated patients vs placebo as both Galcanezumab groups received 240 mg in the first month.
Onset of effect was defined as the earliest week in which a statistically significant separation between Galcanezumab and placebo was observed and maintained for all remaining weeks in month 1.
The weekly MHD analyses showed that onset of effect occurred at week 1.
The odds ratio ( OR ) of having fewer weekly MHDs with Galcanezumab vs placebo was statistically significant at week 1 for each study and remained significant for each of weeks 2‐4.
This rapid onset of effect of Galcanezumab makes it a promising medication for prevention of migraine. ( Xagena )
Source: American Headache Society ( AHS ) Annual Meeting, 2018