Effect of galcanezumab following treatment cessation in patients with migraine: Results from 2 randomized phase 3 trials
Headache: The Journal of Head and Face Pain Jul 15, 2019
Stauffer VL, et al. - Researchers conducted randomized double-blind, placebo-controlled, migraine prevention studies (EVOLVE-1; EVOLVE-2) to investigate the efficacy and safety of galcanezumab after treatment cessation. They randomized 858 and 915 patients in EVOLVE-1 and EVOLVE-2, respectively, to galcanezumab 120 mg (an initial 240-mg loading dose), galcanezumab 240 mg, or placebo, administered subcutaneously once monthly for 6 months. After treatment completion or discontinuation, 740 patients (EVOLVE-1) and 830 (EVOLVE-2) patients entered the posttreatment periods. In EVOLVE-1, they noted a reduction in change from pre-randomization baseline in monthly migraine headache days over the posttreatment period from 5.2 (0.4) days (Month 6) to 4.1 (0.4) days (Month 10) for 120 mg and from 5.3 (0.4) days (Month 6) to 3.8 (0.4) days (Month 10) for 240 mg; the change was stable for placebo (3.4 [0.3] days [Month 6] to 3.3 [0.3] days [Month 10]). Similar results were noted in EVOLVE-2. Findings thereby suggest that during the posttreatment periods, a reduction in galcanezumab treatment effects occur but these did not return to baseline.
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