- Galcanezumab (Emgality) outperformed placebo in reducing monthly migraine days and was overall safe and well tolerated.
Why this matters
- Galcanezumab was superior to placebo on mean reduction in monthly migraine headache days over the course of 3 months:
- 120-mg dose (−4.8 vs −2.7 days; P<.001 and>
- 240-mg dose (−4.6 vs −2.7 days; P<.001>
- Injection-site reaction: 5% vs 2% (P<.01>
- Injection-site erythema: 5% vs 1% (P<.001>
- Injection-site pruritus: 2% vs 0% (P<.01>
- Sinusitis: 3% vs 1% (P<.05>
- Phase 3 randomized controlled REGAIN study in 1113 adult patients with chronic migraine.
- Randomization 2:1:1 to monthly subcutaneous placebo, galcanezumab 120 mg (after 240-mg loading dose), galcanezumab 240 mg.
- 3-month double-blind treatment; 9-month open-label extension.
- Main outcome: change in monthly migraine headache days during double-blind treatment.
- Funding: Eli Lilly and Company.
- Potentially limited generalizability.
- Short-term assessment of efficacy.