New migraine monoclonal antibody
The calcitonin gene-related peptide monoclonal antibody galcanezumab (Emgality, Lilly) compared favorably to placebo for reducing the number of average monthly migraine days in a new study of people with treatment-resistant migraine headaches.
Participants who took the drug experienced "a rapid reduction in migraine days starting as early as month 1, and continuing through the 6 months of the study.
The treatment group reported an average 4.0 fewer monthly migraine days at 3 months, for example, compared with a baseline of 13.4 days, whereas the placebo group decreased an average 1.29 days from a similar baseline of 13.0 migraine days.
These and other results were presented of the open-label phase of the CONQUER phase 3 trial online as part of the 2020 American Academy of Neurology Science Highlights.
The investigators enrolled 462 adults with episodic or chronic migraine. All participants previously failed two to four migraine treatments because of insufficient efficacy or issues around tolerability or safety. At month 0, 232 people were randomly assigned to galcanezumab and another 230 to placebo injections. At 3 months, 449 participants received a galcanezumab injection as part of the open-label treatment phase.
The decrease in migraine days at 3 months - 4.0 days with treatment versus 1.29 with placebo - was statistically significant (P < .0001). During the open-label phase, participants who switched from placebo essentially catch up to where the previously treated people were. At 6 months, the decrease in average monthly headache days was 5.60 in the initial galcanezumab group versus 5.24 in the initial placebo group.
Treatment-emergent adverse events reported in the open-label phase included nasopharyngitis in 4.2%, injection site pain in 3.8%, and injection site erythema in 2.7%. Five participants discontinued during the open-label phase because of adverse events.
The results of the study suggest galcanezumab should be considered as a treatment option for patients who have not had success with previous treatments.