Data from: Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study

Objective: To evaluate the efficacy and safety of galcanezumab, a
humanized monoclonal antibody that selectively binds to calcitonin
gene-related peptide (CGRP), in the preventive treatment of chronic
migraine. Methods: REGAIN was a Phase 3 study with a 3-month double-blind,
placebo-controlled treatment phase and a 9-month open-label extension.
Eligible patients 18-65 years of age with chronic migraine were randomized
2:1:1 to monthly subcutaneous injections of placebo (n = 558),
galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab
240 mg (n = 277). The primary endpoint was the overall mean change from
baseline in the number of monthly migraine headache days (MHDs) during the
3-month double-blind treatment phase. Results: Mean number of monthly MHDs
at baseline was 19.4 for the total sample. Both galcanezumab dose groups
demonstrated greater overall mean reduction in the number of monthly MHDs
than placebo: placebo: -2.7, galcanezumab 120 mg: -4.8, galcanezumab 240
mg: -4.6 (p < 0.001 for each dose compared to placebo). There were
no clinically meaningful differences between galcanezumab doses and
placebo on any safety or tolerability outcome except for a higher
incidence of treatment-emergent injection-site reaction (p < 0.01),
injection-site erythema (p < 0.001), injection-site pruritus (p
< 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg
group relative to placebo. Conclusions: Both doses of galcanezumab were
superior to placebo in reducing the number of monthly MHDs. Galcanezumab
appears efficacious, safe, and well-tolerated for the preventive treatment
of chronic migraine. Classification of evidence: This interventional study
provides Class I evidence that galcanezumab is superior to placebo in the
reduction of the number of monthly migraine headache days.