Treatment with fremanezumab for migraines has been shown to significantly reduce the frequency of migraine days and days on acute headache medication, along with improved headache-related disability and health-related quality of life in patients who responded to treatment, published in the Journal of Headache and Pain.
Previous studies have confirmed the safety and effectiveness of fremanezumab, a monoclonal antibody against the calcitonin gene-related peptide pathway, for migraine prevention. Since the reported efficacy results describe the mean benefit of treatments in patients who responded to treatment and in patients who did not respond to treatment, it is expected that treatment effects will be greater when treating only those who are treated .
The aim of the current post-hoc analysis was to better assess the benefits of fremanezumab in patients who responded to treatment during 2 clinical phase 3 HALO studies.
The analysis included patients with episodic or chronic migraine who were classified as responders to treatment with fremanezumab administered every month or every 3 months in the HALO Episodic Migraine or HALO Chronic Migraine clinical trials. Both studies were 12-week, randomized, double-blind, placebo-controlled studies to determine the effectiveness of fremanezumab.
Measures for the benefit of treatment included migraine days, at least moderate headache days, acute headache medication use, headache-related disability, and general health-related quality of life.
The sample included 857 participants from the 2 studies identified as responders, defined as a reduction of 2 or more monthly migraine days in patients with episodic migraine (429 patients, 73.8%) or 4 or more monthly migraine days in patients with chronic Migraine Migraine (428 patients, 56.7%).
In episodic migraine patients who responded to fremanezumab, there was a significant decrease in the monthly mean number of migraine days with a decrease of 5.4 days for quarterly use of fremanezumab and 5.5 days for monthly use of fremanezumab, and these reductions were greater than those reported in the general population (-3.4 days with fremanezumab quarterly; -3.7 days with fremanezumab monthly). The proportion of subjects with a 50% or more decrease in the average monthly number of migraine days was higher among the responders (59.8% with fremanezumab quarterly; 63.7% with fremanezumab monthly).
The mean number of days on acute headache medication for episodic migraine (-2.9 days with fremanezumab quarterly; -3.0 days with fremanezumab monthly) and the headache-related disability scores were more reduced compared to the general population compared to the general population (Average -23.0 with fremanezumab quarterly; -24.6 points with fremanezumab monthly) and a greater improvement in health-related quality of life.
Treatment benefits were similar in patients with chronic migraine who responded to fremanezumab compared to the population as a whole, with a greater decrease on average in the monthly mean number of migraine days (-4.9 days with fremanezumab quarterly; -5.0 days with fremanezumab monthly) Number of days on acute headache medication (-2.9 days with fremanezumab quarterly; -3.0 days with fremanezumab monthly) and headache-related disability scores, as well as a greater improvement in health-related quality of life.
The researchers recognized several limitations of the study, including the post-hoc analysis of data from two separate studies and a relatively short duration, which is insufficient to determine the long-term benefit of the treatment.
“The results of this study will help inform clinicians’ decision-making and provide guidance to patients about treatment expectations,” the researchers write.
Disclosure: This clinical study was supported by Teva Pharmaceuticals. For a full list of the authors’ information, see the original reference.
SD Silberstein, JM Cohen, R Yang et al. Treatment benefit in migraineurs taking fremanezumab: results of a post-hoc responder analysis from two placebo-controlled studies. Published online 7 January 2021. J Headache. doi: 10.1186 / s10194-020-01212-4
This article originally appeared on Clinical Pain Advisor