- 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.
- 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.
- 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.>
- 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 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.>
- Limited number of patients within each group of prior failures.