Published in:
Open Access
24-11-2023 | Fremanezumab | Original Research Article
Long-Term Treatment Over 52 Weeks with Monthly Fremanezumab in Drug-Resistant Migraine: A Prospective Multicenter Cohort Study
Authors:
Valeria Caponnetto, Antonio Russo, Marcello Silvestro, Alessandro Tessitore, Roberto De Icco, Gloria Vaghi, Grazia Sances, Cristina Tassorelli, Carlo Baraldi, Flavia Lo Castro, Simona Guerzoni, Maria Pia Prudenzano, Adriana Fallacara, Martino Gentile, Raffaele Ornello, Agnese Onofri, Andrea Burgalassi, Alberto Chiarugi, Francesco De Cesaris, Antonio Granato, Alfonsina Casalena, Marina De Tommaso, Edoardo Mampreso, Paola Merlo, Gianluca Coppola, Stefania Battistini, Valentina Rebecchi, Innocenzo Rainero, Federica Nicoletta Sepe, Giorgio Dalla Volta, Simona Sacco, Pierangelo Geppetti, Luigi Francesco Iannone, The Italian Headache Registry (RICe) Study Group
Published in:
CNS Drugs
|
Issue 12/2023
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Abstract
Background
Real-world studies on fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention, are few and with limited follow-up.
Objective
We aimed to evaluate the long-term (up to 52 weeks) effectiveness and tolerability of fremanezumab in high-frequency episodic migraine and chronic migraine.
Methods
This s an independent, prospective, multicenter cohort study enrolling outpatients in 17 Italian Headache Centers with high-frequency episodic migraine or chronic migraine and multiple preventive treatment failures. Patients were treated with fremanezumab 225 mg monthly. The primary outcomes included changes from baseline (1 month before treatment) in monthly headache days, response rates (reduction in monthly headache days from baseline), and persistence in medication overuse at months 3, 6, and 12 (all outcome timeframes refer to the stated month). Secondary outcomes included changes from baseline in acute medication intake and disability questionnaires scores at the same timepoints. A last observation carried forward analysis was also performed.
Results
A total of 90 patients who received at least one dose of fremanezumab and with a potential 12-month follow-up were included. Among them, 15 (18.0%) patients discontinued treatment for the entire population, a reduction in monthly headache days compared with baseline was reported at month 3, with a significant median [interquartile range] reduction in monthly headache days (− 9.0 [11.5], p < 0.001). A statistically different reduction was also reported at month 6 compared with baseline (− 10.0 [12.0]; p < 0.001) and at 12 months of treatment (− 10.0 [14.0]; p < 0.001). The percentage of patients with medication overuse was significantly reduced compared with baseline from 68.7% (57/83) to 29.6% (24/81), 25.3% (19/75), and 14.7% (10/68) at 3, 6, and 12 months of treatment, respectively (p < 0.001). Acute medication use (days and total number) and disability scores were also significantly reduced (p < 0.001). A ≥ 50% response rate was achieved for 51.9, 67.9, and 76.5% of all patients at 3, 6, and 12 months, respectively. Last observation carried forward analyses confirmed these findings. Fremanezumab was well tolerated, with just one patient discontinuing treatment because of adverse events.
Conclusions
This study provides evidence for the real-world effectiveness of fremanezumab in treating both high-frequency episodic migraine and chronic migraine, with meaningful and sustained improvements in multiple migraine-related variables. No new safety issue was identified.