Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE‐1 and EVOLVE‐2

• Published in: Headache Vol. 64; no. 2; pp. 179 - 187
• Main Authors: MacGregor, E. Anne, Okonkwo, Rose, Detke, Holland C., Polavieja, Pepa, Fernandes, Maria S., Pavlovic, Jelena M.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.02.2024
• Subjects: Antibodies, Monoclonal, Humanized; calcitonin gene–related peptide antibody; Clinical trials; Criteria; Diaries; Double-Blind Method; Female; galcanezumab; Headache; Headaches; Humans; menstrual migraine; menstrually related migraine; Migraine; Migraine Disorders - drug therapy; Migraine Disorders - prevention & control; migraine prevention; Monoclonal antibodies; Patients; Placebos; Prevention; Prospective Studies; Quality of Life; Response rates; Standard error; Treatment Outcome; calcitonin gene-related peptide antibody; migraine prevention; galcanezumab; menstrually related migraine; menstrual migraine
• ISSN: 0017-8748; 1526-4610; 1526-4610
• DOI: 10.1111/head.14652

Background We evaluated galcanezumab for migraine prevention in patients who met International Classification of Headache Disorders, 3rd edition criteria for menstrually related migraine (MRM). Methods Patients were identified post hoc from three double‐blind, randomized, phase 3 clinical trials in patients with episodic migraine. Patients completed a 1‐month prospective baseline period and up to 6 months (EVOLVE‐1 and ‐2, studies pooled) of double‐blind treatment with galcanezumab (120 mg/month) or placebo. Menses and headache information were recorded by electronic daily diary. Patients with a migraine attack starting during the 5‐day perimenstrual interval (first day of bleeding ± 2 days) for ≥2 of their first three diary‐recorded menstrual cycles were categorized as having MRM. The primary efficacy measure was mean change in monthly migraine headache days from baseline, averaged over Months 4 through 6. Response rates, change in monthly perimenstrual migraine headache days, monthly non‐perimenstrual migraine headache days, and quality of life were also assessed. Results Post hoc MRM analysis criteria were met by 462/1133 women (41%). Mean (standard deviation) baseline monthly migraine headache days were 9.7 (±3.1; n = 146) for galcanezumab‐treated patients and 9.6 (±2.8; n = 316) for placebo‐treated patients. The mean change (standard error [SE]) in migraine headache days over Months 4 through 6 was −5.1 days (±0.39) for galcanezumab versus −3.2 (±0.35) for placebo (p < 0.001). The mean change (SE) in perimenstrual migraine headache days over Months 4 through 6 was −0.75 days (±0.08) for galcanezumab versus −0.49 (±0.07) for placebo (p = 0.004). For migraine headache days outside the perimenstrual period, the mean change in migraine headache days was −4.6 (±0.38) for galcanezumab and −2.8 (±0.33) for placebo (p < 0.001). Improvements in response rates and the Migraine‐Specific Quality of Life Questionnaire were also observed over Months 4 through 6. Conclusion Galcanezumab was effective for migraine prevention in women with MRM.