Effectiveness of anti-CGRP monoclonal antibodies and onabotulinumtoxinA in menstrually-related migraine: The unmet need of perimenstrual headache days.

BackgroundData on the effectiveness of preventive treatments on menstrually-related migraine (MRM) is scarce. Our objective was to analyze the efficacy of anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP mAbs) and onabotulinumtoxinA (BTX-A) in the reduction of perimenstrual headache days (PHD) and perimenstrual migraine days (PMD) compared to non-perimenstrual headache days (non-PHD) and non-perimenstrual migraine days (non-PMD) per month in women with MRM.MethodsA retrospective study was conducted including females with menstruation and headache records, treated with either anti-CGRP mAbs or BTX-A. Patients completed e-Diary one month before and three months after preventive treatment. We collected clinical data and analyzed PHD/PMD and non-PHD/non-PMD before and after treatment. Additional analyses included PHD/PMD and non-PHD/non-PMD comparisons grouped by aura, episodic/chronic migraine, treatment and contraceptive intake.ResultsWe analyzed data from 113 females with a median (range) age of 39.0 (33.0-45.0) years. When combining patients treated with anti-CGRP mAbs or BTX-A, a median (range) of 2.0 (2.0-3.0) PHD/month (corresponding to 13.6% baseline monthly headache days (MHD)) and 13.0 (9.0-17.0) non-PHD/month pre-treatment was observed. From these, 2.0 (1.0-3.0) were PMD/month, and 7.0 (4.0-11.0) were non-PMD/month. After treatment, the median PHD/month was 2.0 (1.0-3.0) (corresponding to 16.67% of MHD) ( = 0.085), and 8.0 (5.0-13.0) were non-PHD/month ( < 0.001); from these, 1.0 (0.0-3.0) were PMD/month (proportion difference,  = 0.035) and 4.0 (2.0-7.0) were non-PMD (proportion difference,  < 0.001). When analyzing grouped by treatment, only patients treated with anti-CGRP experienced a reduction in PMD. No statistically significant differences in clinical factors (aura, migraine diagnosis, contraceptive intake) between PHD/non-PHD or PMD/non-PMD, either pre- or post-treatment. A higher probability risk of headache and migraine during the perimenstrual window was observed independently of the treatment received (odds ratio = 1.637, 95% confidence interval = 1.356-1.984,  < 0.001).ConclusionsThree-month treatment with anti-CGRP mAbs or BTX-A effectively reduced non-PHD and non-PMD but had limited effect on PHD/PMD because headache probability risk was higher during the perimenstrual window after treatment.