During an international multicenter, randomized, double-blind, placebo-controlled, study, galcanezumab was safe and effective at preventing migraine among patients who had not benefited from previous therapies. These results were published in the Lancet Neurology.
At 64 centers across 12 countries, patients (N=462) with migraine were recruited between 2018 and 2019. Participants had a minimum of 4 headache days and 1 headache-free day monthly during the previous 3 months. Treatment failure from standard of care migraine preventive medications was documented between 2 and 4 times during the previous 10 years. Patients were randomized in a 1:1 ratio to receive 120 mg subcutaneous galcanezumab (n=232) or placebo (n=230) monthly for 3 months with a 240 mg loading dose. Symptoms of migraine were assessed.
Patients had episodic (58%) or chronic (42%) migraines and were well balanced between randomized groups for demographic features at baseline. A total of 11 participants were lost due to protocol deviations or insufficient data.
The number of monthly migraines significantly reduced among participants in the treatment group (effect size, 0.72; least-squares mean change from placebo [mean change], -3.1; 95% CI, -3.9 to -2.3; P <.0001). This difference was similar between those with episodic (effect size, 0.73; mean change, -2.6; 95% CI, -3.4 to -1.7; P <.0001) or chronic (effect size, 0.70; mean change, -3.7; 95% CI, -5.2 to -2.2; P <.0001) migraines.
Among participants who had 2, 3, or 4 previous medication failures, galcanezumab more effectively reduced average monthly headache days (mean change, -2.0; 95% CI, -2.9 to -1.0; P <.0001; mean change, -4.1; 95% CI, -5.8 to -2.4; P <.0001; mean change, -6.1; 95% CI, -9.5 to -2.8; P =.0008), respectively.
The number of patients who reported a 50%, 75%, or 100% reduction of headache days was greater among the treatment group (P <.0001). Among those with episodic migraine in the galcanezumab group, a significantly greater number of patients reported a minimum of 50% reduction of headache days (P £.0001).
Among those with chronic migraine, the proportion of patients reporting a 30% reduction of headache days was 54% and 24%, for the treatment and placebo groups, respectively (odds ratio [OR], 3.8; 95% CI, 2.2-6.3; P <.0001).
Adverse events were reported among 53% of the placebo and 51% of the treatment groups. Most adverse events were mild or moderate. A patient in the galcanezumab cohort discontinued treatment due to a moderate rash which improved upon discontinuation.
A potential limitation of this study was the choice to exclude patients who had more than 4 treatment failures. Therefore, these results may not be generalizable for the most difficult-to-treat patients with migraine.
In summary, these data suggest that galcanezumab was safe and efficacious for the treatment of either episodic or chronic migraine among patients who had experienced multiple treatment failures.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Mulleners W M, Kim B-K, Láinez M J A, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): A multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. doi:10.1016/S1474-4422(20)30279-9