• Galcanezumab for Episodic Migraine

    By Lynda Seminara
    Selected By: Deepak P. Edward, MD

    Journal Highlights

    JAMA Neurology
    Published online Dec. 18, 2017

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    Current medications for migraine have variable efficacy, low adherence, and considerable adverse events (AEs). Recent studies have shown that calci­tonin gene-related peptide is involved in migraine pathophysiology, which has prompted interest in monoclonal antibodies such as galcanezumab as preventive therapy. In a phase 2b trial, Skljarevski et al. compared various monthly doses of galcanezumab with placebo and found that the 120-mg dose of the drug was well tolerated and reduced migraine frequency.

    The trial was conducted in 2014 and 2015 by 37 physicians in the United States. It consisted of 4 periods: screen­ing/washout, prospective baseline (to determine migraine headache days [MHDs]), double-blind treatment, and post-treatment. The primary endpoint was superiority to placebo, evidenced by reduction in MHDs, from baseline to 9 or 12 weeks. Short-term migraine treatments—excluding opioids and barbiturates—were permitted during the trial.

    The 410 enrollees (83% female) had onset of episodic migraine before 50 years of age and were experiencing 4 to 14 MHDs per month. Participants were assigned randomly (2:1:1:1:1) to receive monthly subcutaneous injection of placebo or galcanezumab (5, 50, 120, or 300 mg) for 3 months.

    Period 3 of the trial was completed by 375 patients (galcanezumab, n = 249; placebo, n = 126). By month 3 of treatment, the 120-mg dose of galcanezum­ab had significantly reduced MHDs (‒4.8 MHDs; ‒5.4 to ‒4.2 MHDs) versus placebo (‒3.7 MHDs; ‒4.1 to ‒3.2 MHDs). From baseline to month 3, both the 120- and 300-mg doses of galcanezumab were more effective than placebo in reducing the overall number of MHDs. The frequency of treatment-emergent AEs was comparable for active-treatment groups. The most common AEs were upper respiratory tract infection, pain at the injection site, nasopharyngitis, nausea, and dys­menorrhea.

    The authors cautioned that the small sample size precludes definitive conclusions about the safety of galca­nezumab. However, they encouraged phase 3 investigation of varying doses of the drug to further assess its safety and efficacy for episodic migraine.

    The original article can be found here.