Efficacy and Safety of Fremanezumab in Patients with Migraine: Real-World Evidence in a Private Neurological Center

Introduction: Migraine is the first cause of disability under 50 years of age. In the last decade there were significant advances in the comprehension of this disorder that led to the development of specific treatments, such as those targeting calcitonin gene-related peptide (CGRP) or its receptor including monoclonal antibodies. Here, we present real life results of a cohort of migraine patients treated with fremanezumab. Material and Methods: We analysed data, collected prospectively for 18 months, of consecutive patients with migraine treated with fremanezumab in a Lisbon center. Patients had a baseline evaluation and monthly visits. Data included monthly headache days, a composite headache measure (days x pain intensity), acute treatment intake and adverse events. Patients also fulfilled quality of life and migraine impact scales at 1st, 3rd, 6th, 9th and 12th months of treatment and were evaluated after treatment withdrawal. Efficacy was defined as a reduction ≥ 30% or ≥ 50% of the number of monthly headache days (in chronic and episodic migraine, respectively) compared to baseline. Results: We included 29 patients (47.8 years of age, 25 female) with chronic (n=20) or high frequency episodic (n=9), migraine previously resistant to an average of 3.3 oral preventives/botulinum toxin, 20 with medication overuse. Efficacy increased from 62% in the 1st month to 76.9% on the 3rd and there was a significant reduction of migraine headache days, acute medication intake, index and HIT-6 scores and improved quality of life in all assessment periods compared to baseline. The most common adverse events were constipation (27.6%) and pain on the injection site (20.7%) leading to interruption of treatment in one patient. There was no increase in the number of headache days or acute medication intake five months after treatment interruption. Conclusion: These results corroborate data from clinical trials about the efficacy and safety of fremanezumab, showing an improvement of different migraine measures and impact, even in patients with resistant migraine and medication overuse. In general, adverse events were well tolerated not leading to treatment withdrawal.