Anesthesia Experts

Fremanezumab for Migraine Prevention in Patients with Multiple Treatment Failures

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Authors: Ferrari MD et al.

Lancet 2019 Aug 16 Tessitore A and Russo A. Lancet 2019 Aug 16

Fremanezumab is a well-tolerated and effective preventive therapy in patients with migraine for whom two to four preventives have failed.

Researchers conducted a phase IIIb randomized controlled trial with fremanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody, funded by the manufacturer. Patients with either episodic (n=329) or chronic migraine (n=509) who had failed two to four previous preventives (including beta-blockers, tricyclic antidepressants, valproate, topiramate, candesartan, flunarizine, and onabotulinumtoxinA) were randomized to placebo, to quarterly subcutaneous injections of 675 mg of fremanezumab (n=276) or to monthly subcutaneous injections of 225 mg (n=283) for 12 weeks.

Episodic and chronic migraineurs treated either with quarterly or monthly fremanezumab collectively had significantly fewer migraine days than placebo recipients: 3.1 and 3.5 fewer, respectively. A difference was observed regardless of previous treatment failure with either topiramate, valproate or onabotulinumtoxinA. Compared with placebo recipients, patients treated with fremanezumab (either monthly or quarterly) had significantly fewer headache days and acute-medication use days per month, and a greater number had a ≥50% reduction in migraine days. Adverse events were comparable between placebo and fremanezumab groups. With fremanezumab, injection site reactions were most common, primarily erythema (7% in the quarterly treatment group). Discontinuations due to side effects were uncommon (no more than 1% per randomization group).

COMMENT

This study demonstrates preventive efficacy with few side effects from fremanezumab in patients with difficult-to-treat migraine. However, continued efficacy beyond 12 weeks has yet to be demonstrated and can only be inferred from results of the 1-year study (Neurology 2019; 92 [15 Suppl]:S38.004). A long-term study in this patient group would be welcomed.

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