Treatment with fremanezumab for migraine is associated with significant reductions in the frequency of migraine days and days with acute headache medication use, along with improved headache-related disability and health-related quality of life in patients who responded to the treatment, according to study results published in The Journal of Headache and Pain.

Previous studies have supported the safety and efficacy of fremanezumab, a monoclonal antibody targeting the calcitonin gene-related peptide pathway, for migraine prevention. Because reported efficacy outcomes describe the mean benefits of treatments across patients who responded and those who did not respond to treatment, the treatment effects are expected to be more pronounced when focusing only on those who respond to treatment.

The objective of the current post hoc analysis was to better assess the benefits of fremanezumab in patients who responded to treatment during 2 phase 3 HALO clinical trials.


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The analysis included patients with episodic or chronic migraine who were classified as responders to fremanezumab treatment given every month or every 3 months in the HALO episodic migraine or the HALO chronic migraine clinical trials. Both studies were 12-week, randomized, double-blind, placebo-controlled studies to determine the efficacy of fremanezumab.

Treatment benefit outcome measures included migraine days, headache days of at least moderate severity, acute headache medication use, headache-related disability, and overall health-related quality of life.

The study sample included 857 participants from the 2 trials who were 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 those with chronic migraine (428 patients, 56.7%).

Among patients with episodic migraine who responded to fremanezumab, there was a significant reduction in the monthly average number of migraine days, with a decrease of 5.4 days with fremanezumab used quarterly and of 5.5 days with fremanezumab used monthly, and these reductions were greater than those reported in the overall population (-3.4 days with fremanezumab quarterly; -3.7 days with fremanezumab monthly). The proportion of subjects with a 50% or greater reduction in the average monthly number of migraine days was greater in responders (59.8% with fremanezumab quarterly; 63.7% with fremanezumab monthly).

There was a greater reduction among responders compared with the overall population in the average number of days of acute headache medication use for episodic migraine (-2.9 days with fremanezumab quarterly; -3.0 days with fremanezumab monthly), and headache-related disability scores according to Migraine Disability Assessment score (average, -23.0 with fremanezumab quarterly; -24.6 points with fremanezumab monthly), along with a larger improvement in health-related quality of life.

The treatment benefits were similar among those with chronic migraine who responded to fremanezumab, compared with the overall population, with a greater reduction in the monthly average number of migraine days (-4.9 days with fremanezumab quarterly; -5.0 days with fremanezumab monthly), average number of days of acute headache medication use (-2.9 days with fremanezumab quarterly; -3.0 days with fremanezumab monthly), and headache-related disability scores, along with a larger improvement in health-related quality of life.

The researchers acknowledged several study limitations, including the post-hoc analyses of data from 2 separate trials, and a relatively short duration that is not sufficient to determine the long-term benefits of the treatment.

“The results from this study will help to inform clinicians’ decision making and provide guidance for patients regarding treatment expectations,” wrote the researchers.

Disclosure: This clinical trial was supported by Teva Pharmaceuticals. Please see the original reference for a full list of authors’ disclosures.

Reference

Silberstein SD, Cohen JM, Yang R, et al. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. Published online January 7, 2021. J Headache Pain. doi:10.1186/s10194-020-01212-4