Galcanezumab may effectively Alleviate Menstrual Migraine: Post-hoc Analysis
Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated significant effectiveness in patients with episodic migraine experiencing menstrual migraine compared with placebo. The study findings were presented at the 63rd Annual Scientific Meeting of the American Headache Society.
A high proportion (>50%) of women report an association between migraine and menstruation. In women with menstrually related migraine (MRM), perimenstrual attacks are longer, more disabling, and treatment-resistant compared with non-menstrually related attacks. Therefore, Dr MacGregor E and his team conducted a study to evaluate the efficacy of galcanezumab, a calcitonin gene-related peptide antibody, in reducing migraine headache days in women with menstrual migraine (MM), defined as MRM or pure menstrual migraine (PMM).
In this post-hoc analysis, the researchers evaluated three-phase 3 randomized, double-blind, placebo-controlled studies of galcanezumab, EVOLVE-1, EVOLVE-2 and CONQUER. They identified 459 women from three studies who have 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). The major outcome assessed was overall mean change from baseline in 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 researchers used linear mixed model repeated measures to assess outcomes.
Key findings of the study were:
- At baseline, the researchers noted that the mean migraine headache days were 9.5 and 9.7 in the placebo and galcanezumab 120-mg/month groups in EVOLVE-1 and EVOLVE-2, respectively, and 9.7 for both groups in the CONQUER study.
- Among patients experiencing episodic migraine-MM in the EVOLVE-1 and EVOLVE-2 study, the researchers found that the mean changes from baseline in monthly migraine headache days and monthly migraine headache days with acute medication use were significantly lower in the galcanezumab 120 mg/month group (−4.58 and −3.67, respectively) versus placebo (−2.64 and −1.85, respectively).
- Similarly, they sound significant mean reductions in baseline monthly migraine headache days and migraine headache days with acute medication use with galcanezumab 120 mg/month compared with placebo among patients with episodic migraine experiencing MM in the CONQUER study.
The authors concluded, "Galcanezumab 120 mg significantly reduced monthly migraine headache days and monthly migraine headache days with acute medication use compared with placebo in patients with episodic migraine experiencing MM".
For further information:
MacGregor E et al., Effect of galcanezumab on migraine days in women with menstrual migraine: A post hoc analysis. (2021),63rd Annual Scientific Meeting American Headache Society®. Headache: The Journal of Head and Face Pain, 61: 1-178. https://doi.org/10.1111/head.14130
Category: Other Clinical Studies
Abstract Number: IOR-01