Long-term efficacy and safety of fremanezumab in treatment-resistant migraine

Fremanezumab, a fully-humanised monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP), demonstrated sustained efficacy up to 6 months and long-term tolerability in patients with episodic or chronic migraine who had an inadequate response to 2-4 classes of prior migraine preventive medications [1].

The double-blind, placebo-controlled, phase 3b FOCUS trial included patients with episodic or chronic migraine, who had an inadequate response to 2-4 prior classes of migraine preventive medications. The study included a 12-week double-blind period and 12-week open-label extension phase. Patients were initially randomised to:

• quarterly fremanezumab: 675 mg in month 1 and placebo in months 2 and 3;
• monthly fremanezumab: 675 mg in patients with chronic migraine and 225 mg in patients with episodic migraine in month 1, and thereafter 225 mg in months 2 and 3; or
• matched monthly placebo.

Study medication was given for 12 weeks. Previous results from the 12-week treatment period demonstrated that fremanezumab was effective and well tolerated.

During the open-label extension of FOCUS, the long-term efficacy and tolerability of fremanezumab were evaluated. Mean changes from baseline in monthly average migraine days during the 12-week open-label extension period was -4.7 in the placebo group, -5.1 in the quarterly fremanezumab group, and -5.5 in the monthly fremanezumab group. Mean changes in monthly average headache days of at least moderate severity were -4.5, -4.8, and -5.2, respectively.

The proportion of patients who achieved ≥50% reduction from baseline in monthly average migraine days was similar in patients continuing fremanezumab (quarterly, 45%; monthly, 46%) and switching from placebo (38%). Furthermore, substantial reductions in disability were observed with fremanezumab treatment, as well as sustained reductions in migraine-related symptoms, such as nausea or vomiting, photophobia, and phonophobia.

During the open-label extension period, regardless of the prior double-blind period treatment, proportions of patient-reported adverse events (AEs) were similar between patient groups. The most common AEs were injection-site related (erythema, induration, and pain). The incidence rates of AEs ranged from 2–5% with placebo and 3–6% with fremanezumab during the double-blind and open-label extension periods. No safety signals were identified.

The FOCUS study showed that fremanezumab demonstrated sustained efficacy up to 6 months and long-term tolerability in patients with episodic or chronic migraine who had an inadequate response to 2–4 classes of prior migraine preventive medications.

1. Ashina M. Long-term efficacy and safety of fremanezumab in patients with episodic and chronic migraine who had inadequate response to 2-4 prior migraine preventive medication classes: open-label extension of the phase 3B FOCUS study. MTIS Virtual Symposium 2020, abstract MTV20-DP-064.

Posted on 27 October 202023 April 2024