The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study.

OBJECTIVE: To evaluate the frequency and headache-related impact response to monoclonal antibodies against calcitonin gene-related peptide (CGRP) in a clinical sample of refractory migraine patients.

METHODS: We included migraine patients with ≥ 8 headache days/month that had failed at least three preventive medications. Demographic, medical and migraine history were collected. Patients completed an electronic headache diary including headache days/month, migraine days/month, headache pain intensity (0-3 numerical scale), use of analgesics and completed Patient-Reported Outcome questionnaires at baseline and after 12 weeks. Patients were classified into ≥ 50%, ≥ 75% and 100% responders according to the improvement in frequency.

RESULTS: We included 155 patients (109 erenumab and 46 galcanezumab). After 12 weeks, headache frequency decreased - 9.1 headache days/month and - 8.5 migraine days/month from baseline. A 39.5% had a ≥ 50% headache days/month reduction and a 51.6% ≥ 50% migraine days/month reduction. In the ≥ 50% migraine days/month-responders group, frequency reduction was - 13,9 migraine days/month from baseline and showed clear improvements for all patient-reported outcomes. A 14.2% and 26.5% had a ≥ 75% response in headache and migraine days/month, respectively, and 11.0% showed a 100% migraine days/month reduction. Patients who were not on other preventive medications had less severe disability and higher ratio of migraine over headache days/month were more likely of being a ≥ 50% migraine days/month-responder. We did not record any severe adverse events, being the most common constipation (20.0%), fatigue (7.1%) and a transient increase in blood pressure (5.2%).

CONCLUSIONS: In real-world clinical practice, monoclonal antibodies against CGRP proved to be effective treatments in resistant migraine patients.