Abstract
BackgroundMaintenance of effect following treatment with galcanezumab compared to placebo in adult patients with episodic or chronic migraine was evaluated.MethodsIn 2 similarly designed studies of patients with episodic migraine (6 months) and 1 study of patients with chronic migraine (3 months), patients randomized in a 1:1:2 ratio received a subcutaneous injection of galcanezumab 120 mg/month (after an initial loading dose of 240 mg) or 240 mg/month or placebo. Maintenance of effect during the double-blind phase was evaluated based on a comparison of the percentages of galcanezumab- and placebo-treated patients with maintenance of 30, 50, 75, and 100% response (defined as ≥30, ≥50, ≥75, and 100% reduction from baseline in monthly migraine headache days [MHD]) at an individual patient level. Logistic regression analyses were used for between treatment comparisons.ResultsA total of 1773 adult patients with episodic migraine (n = 444 for galcanezumab 120 mg; n = 435 for galcanezumab 240 mg; n = 894 for placebo for 2 studies pooled) and 1113 patients with chronic migraine (n = 278 for galcanezumab 120 mg; n = 277 for galcanezumab 240 mg; n = 558 for placebo) were evaluated. In patients with episodic migraine, ≥50% response was maintained in 41.5 and 41.1% of galcanezumab-treated patients (120 mg and 240 mg, respectively) for ≥3 consecutive months (until patient’s endpoint) and 19.0 and 20.5%, respectively, for 6 consecutive months and was significantly greater than the 21.4 and 8.0% of placebo-treated patients at ≥3 and 6 months consecutively (P < 0.001). Approximately 6% of galcanezumab-treated patients maintained ≥75% response all 6 months versus 2% of placebo-treated patients. Few galcanezumab-treated patients maintained 100% response. In patients with chronic migraine, 29% of galcanezumab-treated patients maintained ≥30% response all 3 months compared to 16% of placebo patients while ≥50% response was maintained in 16.8 and 14.6% of galcanezumab-treated patients (120 mg and 240 mg) and was greater than placebo (6.3%; p < 0.001). Few patients maintained ≥75% response.ConclusionsTreatment with galcanezumab 120 mg or 240 mg demonstrated statistically significant and clinically meaningful persistence of effect in patients with episodic migraine (≥3 and 6 consecutive months) and in patients with chronic migraine (for 3 months).Study identification and trial registrationStudy Identification: EVOLVE-1 (I5Q-MC-CGAG); EVOLVE-2 (I5Q-MC-CGAH); REGAIN (I5Q-MC-CGAI)Trial RegistrationClinicalTrials.gov; NCT02614183 (EVOLVE-1); NCT02614196 (EVOLVE-2); NCT02614261 (REGAIN)
Highlights
Maintenance of effect following treatment with galcanezumab compared to placebo in adult patients with episodic or chronic migraine was evaluated
The current study evaluated data from the placebocontrolled EVOLVE-1 and EVOLVE-2 episodic migraine trials and the REGAIN chronic migraine trial and compared galcanezumab treatment to placebo in the maintenance of ≥30%, ≥50, ≥75, and 100% response in the reduction of Migraine headache days (MHD) from baseline
Patient disposition Data from the episodic migraine trials were from 1773 adult patients with episodic migraine treated with 120 mg galcanezumab (n = 444), 240 mg galcanezumab (n = 435), or placebo (n = 894)
Summary
Maintenance of effect following treatment with galcanezumab compared to placebo in adult patients with episodic or chronic migraine was evaluated. The mean monthly percentages of galcanezumab-treated patients with episodic migraine or chronic migraine that achieved ≥50% reduction in MHD was greater than the percentages of placebo-treated patients (60% versus 36% to 39% and 27% versus 15%, respectively) [2,3,4]. The important question of whether a ≥ 50% reduction in monthly MHD is maintained over time has not been sufficiently addressed for both episodic and chronic migraine [5, 8,9,10]. Can the additional responses of ≥30, ≥75, and 100% reduction in monthly MHD, recognized to be clinically meaningful, be maintained [11,12,13]? Tachyphylaxis has been reported frequently by patients and physicians
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