Migraine: galcanezumab prophylaxis found effective in REGAIN

  • Detke HC & al.
  • Neurology
  • 16 Nov 2018

  • curated by Susan London
  • Clinical Essentials
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Takeaway

  • Galcanezumab (Emgality) outperformed placebo in reducing monthly migraine days and was overall safe and well tolerated.

Why this matters

Key results

  • 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>
  • Differences significant for proportions achieving ≥50% reduction and ≥75% reduction, but not 100% reduction.
  • Rate of treatment-emergent adverse events: placebo, 50%; 120-mg dose, 58% (P<.05 dose>
  • Treatment-emergent adverse events more common with galcanezumab 240 mg vs placebo:
    • 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>

Study design

  • 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.

Limitations

  • Potentially limited generalizability.
  • Short-term assessment of efficacy.

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