The CGRP inhibitor proved to be an effective and safe medication in patients with chronic and episodic migraine when used over a 12-month period. Data from the extension study were presented at the 2019 American Academy of Neurology Annual Meeting.
The evaluation of long-term effects is based on a randomized, double-blind, parallel-group multicenter extension study in patients with chronic and episodic migraine over a 52-week period. The extension study included patients from two placebo-controlled studies, as well as 312 new study participants. A total of 1890 study participants with chronic and episodic migraine were enrolled in the study, of which 1494 participants completed 12 months of treatment. Patients were instructed to take fremanezumab either monthly at a dose of 225 mg (resp. for chronic migraine with an initial dose of 675 mg) or to be applied every three months at a dose of 675 mg.
Analysis of data from study participants with chronic migraine (n=1100) 12 months after baseline yielded the following results [1]. A ≥50% reduction in the mean number of monthly migraine days was achieved by 53% of the quarterly dosing group and 57% in the monthly dosing condition. Response rates in terms of reduction in the number of days with at least moderate headache were similar (54% and 59%, respectively). Analysis of data from study participants with episodic migraine (n=780) 12 months after baseline [2] showed that 66% of patients in the quarterly fremanezumab administration group achieved a ≥50% reduction in the mean number of monthly migraine days, compared with 68% in the monthly administration group. Response rates in terms of reduction in the number of days with at least moderate headache were similar. Both patients with chronic migraine and those with episodic migraine showed a measurable reduction in the use of acute headache medication and an improvement in limitations over a one-year observation period [1,2]. There was no wearing out effect [3] at the 3-month interval compared with the 1-month interval, according to the safety analysis of fremanezumab [4]. injection site reactions were the most commonly reported adverse event (26-33% of all participants). The side-effect-related dropout rate was 4%.
The drug Ajovy™ (fremanezumab) has been approved in the US since September 2018 and in the EU since April 2019 for the preventive treatment of migraine in adults. CGRP is a vasoactive peptide secreted by the activated trigeminal nerve that facilitates pain transmission from cerebral blood vessels to the central nervous system [5]. CGRP is thought to play a central role in the pathophysiology of migraine. Both fremanezumab, galcanezumab, and eptinetzmab are effective and generally well tolerated. In contrast to Erenumab, a migraine prophylactic of the same substance class, which targets the CGRP receptor, Fremanezumab and Galcanezumab deactivate the CGRP receptor by binding to it [6].
Source: TEVA Pharma AG
Literature:
- Mcallister P, et al: Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients With Chronic Migraine: Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
- Brandes JL, et al: Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients With Episodic Migraine: Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
- Blaise CA, et al: Quarterly Administration of Fremanezumab Does Not Show “Wearing Off” Effect During Third Month After Injection. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
- Ning X, et al: Long-Term Safety of Fremanezumab: Results of a 1-Year Study. Presented at: 2019 AAN Annual Meeting, Philadelphia, PA.
- Doods H, et al: CGRP antagonists: unravelling the role of CGRP in migraine. Trends Pharmacol Sci 2007; 28(11): 580-587.
- Goadsby PJ, et al: A controlled trial of erenumab for episodic migraine. New Eng J Med 2017; 377(22): 2123-2132.
HAUSARZT PRAXIS 2019; 14(6): 4
