Abstract text (incl. figure legends and references)

Question: The monoclonal antibodies anti-CGRP/CGRPr have a promising role in the treatment of migraine. We aimed to evaluate the efficacy, safety, and side effect profile of fremanezumab in patients with refractory migraine and medication-overuse headache in a Portuguese tertiary hospital.
Methods: A longitudinal observational study of a consecutive sample of patients with refractory migraine and medication-overuse headache treated with fremanezumab.
Results: Fifteen patients were included: fourteen were female, with a mean age of 46 years. All patients had chronic migraine and were previously treated with ≥4 preventive drugs. Nine patients had 3 administrations of fremanezumab, six patients had ≥4 administrations. The analgesic drugs being abused were triptans and NSAIDs in 10 patients, only triptans in 2 patients, only NSAIDs in 1 patient, ergotamine and acetaminophen in 1 patient and opioids in 1 patient. The mean headache frequency at 12 weeks was significantly lower than at the baseline (p=0.005). The Headache Impact Test score at 12 weeks was significantly lower (p=0.019). The reduction in monthly headache frequency was ≥50% in 8 patients, ≥75% in 6 patients and <30% in 4 patients. All the patients with a reduction in monthly headache frequency ≥30% suspended the medication over-use and continued the treatment the fremanezumab for another 12 weeks. Of the patients with a reduction in headache frequency <30%, 2 over-used both triptans and NSAIDs, 1 over-used opioids and 1 over-used ergotamine and acetaminophen compounds: 2 patients switched treatment to erenumab, 1 stoped anti-CGRP/CGRPr drugs and 1 waits the group decision. Reported side effects were mild and didn"t lead to discontinuation of the drug.
Conclusions: In our cohort of patients with refractory migraine and medication over-use headache, the use of fremanezumab lead to a significant decrease in both the frequency and impact of the headache, and suspension of the medication overuse in most patients.