Study Finds Erenumab Safe, Effective in Treating Menstrual Migraine

Data from women with menstrual migraine enrolled in the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) show erenumab is a safe and effective option for treating the condition. Results from the post hoc subgroup analysis were published in The Journal of Headache and Pain.

Over 50% of women self-report an association between migraine and menstruation. However, these perimenstrual attacks are considered menstrual migraines if they occur within the 5-day window of the 2 days prior to menstruation and the first 3 days of menstruation.

“Menstrual migraine attacks are particularly burdensome, as they tend to be longer and are more severe and disabling than non-perimenstrual attacks,” the researchers said. The attacks are also less responsive to acute therapy, making them difficult to treat. Currently, there are no approved, specific preventive treatments for menstrual migraine.

Erenumab, which was approved by the FDA in 2018, is a calcitonin gene-related peptide (CGRP) inhibitor administered via self-injection once a month. The treatment blocks the CGRP receptor, which is believed to play a crucial role in migraine. Erenumab can be injected as a 70- or 140-mg dose in adults with migraine.

STRIVE is a phase 3, randomized, double-blind, placebo-controlled study that tested the safety and efficacy of erenumab in patients with migraine between the ages 18 and 65. The study included a 7-week screening phase, a 6-month double-blind treatment phase, a 7-month dose-blinded active treatment phase, and a 3-month safety follow-up phase.

All women included in the sub-group analysis (n = 232 [28.5% of total STRIVE female enrollees]) were ≤50 years and had a self-reported history of menstrual migraine attacks. However, the data did not allow researchers to distinguish between those with only menstrual attacks and those with both menstrual and nonmenstrual attacks.

Throughout the study, 65 (28%) women took oral contraceptives/hormone therapy: 18 (26%) in the erenumab 70-mg arm, 27 (33%) in the erenumab 140-mg arm, and 20 (24%) in the placebo group.

The researchers found both doses of erenumab resulted in statistically significantly greater reductions in monthly migraine days (MMD) as early as month 1 compared with the placebo arm.

Additional findings include:

• Mean MMD reduction over months 4 to 6 was 1.4, 3.2, and 3.5 days in the placebo, erenumab 70-mg, and erenumab 140-mg groups, respectively
• Differences from the placebo arm were –1.8 (P = .001) and −2.1 (P < .001) days for the erenumab 70-mg and 140-mg groups, respectively
• In patients who were taking acute migraine-specific medications at baseline, erenumab 70 mg and 140 mg vs placebo resulted in greater reductions in monthly acute migraine-specific medication days (MSMD) starting at month 1; reductions were statistically significant at every month for the 140-mg dose group
• Mean reduction in monthly acute MSMD over months 4 to 6 was 0.4, 2.0, and 2.8 days in the placebo, erenumab 70-mg, and erenumab 140-mg groups, respectively
• Differences from placebo in this group were also statistically significant: –1.6 (P = .002) and −2.4 (P < .001) days for the erenumab 70-mg and 140-mg groups, respectively

Further analyses revealed both doses of erenumab resulted in a significantly higher proportion of patients achieving at least a 50% response at each time point except month 4 compared with the placebo arm.

Data showed:

1. A ≥ 50% response over months 4 to 6 was achieved by 25.3%, 42.6%, and 49.4% of patients who received placebo, erenumab 70 mg, and erenumab 140 mg, respectively
2. The odds of having a ≥ 50% response over months 4 to 6 were 2.2 (P = .024) and 2.8 (P = .002) times greater for the erenumab 70-and 140-mg groups, respectively, than for the placebo group

Patients receiving exogenous hormones demonstrated similar efficacy results compared with the total population of women with a history of menstrual migraine, but the researchers caution the sample sizes of these subgroups were too small to draw any definitive conclusions.

“Further investigation appears warranted, as several studies suggest that fluctuations of ovarian steroid hormone levels may modulate CGRP, with high estrogen states being related to an increase in CGRP levels in general, although the exact mechanistic interactions between ovarian steroid hormones and CGRP are not fully understood,” the authors write.

In addition, the overall safety profile of erenumab was similar to that of the placebo, and no cardiovascular adverse events were reported in patients with menstrual migraine.

Reference

Pavlovic JM, Paemeleire K, Göbel H, et al. Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain. Published online August 3, 2020. doi:10.1186/s10194-020-01167-6