Galcanezumab reduces monthly headache days in women with menstrual migraine
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Women with menstrual migraine who were treated with galcanezumab had fewer monthly migraine headache days compared with women who received placebo, according to an analysis of three phase 3 trials.
“Of clinical importance is that in women diagnosed with menstrually related migraine, peri-menstrual attacks are less responsive to symptomatic treatment compared to attacks occurring at other times in the cycle,” E. Anne MacGregor, MBBS, MSc, MD, FFSRH, a specialist in headache and sexual and reproductive health care at Barts Health NHS Trust in London, said during a presentation at the American Headache Society Annual Scientific Meeting. “Clearly, there are benefits to preventing these attacks rather than relying on the limited efficacy of symptomatic treatment alone.”
MacGregor and colleagues conducted a post-hoc analysis of three phase 3 randomized, double-blind, placebo-controlled trials, EVOLVE-1, EVOLVE-2 and CONQUER. Participants in each of the three studies completed daily electronic diaries with headache information and menstrual status and were randomly assigned to receive either 120 mg galcanezumab (EVOLVE-1, EVOLVE-2: n = 144; CONQUER: n = 47) per month or placebo (EVOLVE-1, EVOLVE-2: n = 315; CONQUER: n = 52). Outcome measures included monthly migraine headache days, monthly migraine headache days with acute headache medication use, 50% response rate and Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain.
The mean decreases in monthly migraine headache days among the galcanezumab group in the EVOLVE-1 and EVOLVE-2 studies were: 4.06 at month 1 (vs. placebo, 1.23), 4 at month 2 (vs. placebo, 2.42), 4.21 at month 3 (vs. placebo, 2.6), 4.75 at month 4 (vs. placebo, 3.01), 5.51 at month 5 (vs. placebo, 3.26) and 4.94 at month 6 (vs. placebo, 3.32). In the CONQUER trial, patients in the treatment group had monthly migraine headache day reductions of 2.79 at month 1 (vs. placebo, 0.66), 2.71 at month 2 (vs. placebo, 0.66) and 2.79 at month 3 (vs. placebo, 0.2).
Among patients treated with acute medication, the mean decreases in monthly migraine headache days among the treatment group in EVOLVE-1 and EVOLVE-2 were 4.06 at month 1 (vs. placebo, 1.23), 4 at month 2 (vs. placebo, 2.42), 4.21 at month 3 (vs. placebo, 2.6), 4.75 at month 4 (vs. placebo, 3.01), 5.51 at month 5 (vs. placebo, 3.26) and 4.94 days at month 6 (vs. placebo, 3.32). In the CONQUER trial, the mean decreases in monthly headache days in the treatment group were 2.79 at month 1 (vs. placebo, 0.66), 2.71 at month 2 (vs. placebo, 0.66) and 2.79 at month 3 (vs. placebo, 0.2).
The proportion of patients in the treatment groups with reductions of 50% or more in the number of monthly migraine headache days were 55.4% (vs. placebo, 32.6%) in the EVOLVE-1 and EVOLVE-2 trials and 35% (vs. placebo, 10.3%) in the CONQUER trial. The mean improvement in MSQ-RFR domain scores for the treatment groups was 29 (vs. placebo, 20.6) in the EVOLVE-1 and EVOLVE-2 studies and 20.6 (vs. placebo, 12.4) in the CONQUER study.
“In conclusion, this post-hoc analysis of three double-blind clinical trials included 558 women with episodic migraine at baseline in whom daily e-diary data were used to diagnose menstrual migraine,” MacGregor said. “So these results show that galcanezumab 120 mg per month was significantly more effective than placebo for preventing migraine in this population of women who’d been diagnosed with menstrually-related migraine.”