Migraine: galcanezumab shows efficacy in phase 3 trial

  • Ruff DD & al.
  • Cephalalgia
  • 1 Jul 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • Galcanezumab was efficacious vs placebo in patients with migraine who had previously failed other migraine therapies and may also be suitable in those without any prior preventive treatment.
  • Galcanezumab consistently reduced monthly migraine headache days (MHDs) and other key outcomes in patients who had failed ≥2 or ≥1 preventives previously.

Why this matters

  • NICE is soon expected to begin a technology appraisal of galcanezumab for the treatment of migraine.

Study design

  • In this phase 3 randomised placebo controlled REGAIN trial, 1113 patients (age, 18-65 years) were randomised 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a treatment period lasting 3 months.
  • Funding: Eli Lilly and others.

Key results

  • Treatment with galcanezumab vs placebo significantly reduced the number of monthly MHDs in patients with prior failures.
  • 50% reduction in MHDs among patients who failed ≥2 and ≥1 prior preventives:
    • galcanezumab 120 mg vs placebo: 29.6% vs 9.4% (OR, 4.05; P<.001 and vs p respectively.>
    • galcanezumab 240 mg vs placebo: 18.7% vs 9.4% (OR, 2.22; P<.01 and vs p respectively.>
  • 75% reduction in MHDs among patients who failed ≥2 and ≥1 prior preventives:
    • galcanezumab 120 mg vs placebo: 6.3% vs 2.3% (OR, 2.87; P<.05 and vs p respectively.>
    • galcanezumab 240 mg vs placebo: 5.0% vs 2.3% (OR, 2.27; 95% Cl, 0.95-5.42) and 6.0% vs 2.7% (OR, 2.27; P<.05 respectively.>
  • Galcanezumab vs placebo showed significant larger overall reduction in MHDs with acute migraine medication use among patient who failed ≥2 and ≥1 prior preventives.
    • galcanezumab 120 mg vs placebo: −5.81 vs −1.35 (Δ–4.46; P<.001 and vs p respectively.>
    • galcanezumab 240 mg vs placebo: −3.40 vs −1.35 (Δ–2.06; P<.01 and vs p respectively.>

Limitations

  • Limited number of patients within each group of prior failures.