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Factors Associated with Significant Reduction in Migraine Headache Days: A Post Hoc Analysis of a Phase II Placebo-Controlled Trial in Patients Treated with Galcanezumab (P2.177)

Objective: To determine if there are clinical predictors of response to galcanezumab in patients with episodic migraine. Background: Migraine remains undertreated with few preventive medications available. Design/Methods: This was a post hoc analysis of a Phase II clinical trial in which patients 18–65 years of age with 4–14 migraine headache days (MHD) per month were randomized 2:1:1:1:1 to placebo or 1 of 4 galcanezumab dose groups(5, 50, 120, and 300 mg) given subcutaneously once monthly for 3 months. The objective of this post hoc analysis was to determine if there were any clinical predictors with differential treatment effects for reduction in MHD at 3months. Candidate baseline subgroup variables pre-specified before study un blinding included: number of MHD, migraine with or without aura, or triptan use, history of failure to preventive treatments, duration of migraine history, gender. To assess treatment by subgroup interaction at Month 3 for the primary efficacy measure of change from baseline in MHD, a mixed model repeated measures analysis was conducted with terms of treatment, baseline, month, subgroup, pooled investigative sites, treatment-by-month, baseline-by-month, subgroup-by-treatment, subgroup-by-month, subgroup-by-treatment-by-month interactions. Significant interaction would have a p-value Results: Compared with its respective counterpart, subgroups with statistically significantly greater treatment effect (galcanezumab vs placebo difference) at Month 3 included patients previously treated with triptans in the 300 mg dose group; duration of migraine history of >20 years in the 120 mg group; and history of failure to preventive treatments in the 300 mg dose group. Conclusions: In this posthoc analysis there is preliminary evidence that there may be some predictors of clinical response with greater treatment effects in episodic migraineurs. These include prior triptan use, migraine history >20 years, and history of failure to preventive treatments. Study Supported by: Eli Lilly and Company, Indianapolis, IN Disclosure: Dr. Aurora has received personal compensation for activities with Eli Lilly and Company as an employee and Allergan as a consultant. Dr. Aurora hold stock and/or stock options in Lilly and Company. Dr. Oakes has received personal compensation for activities with Eli Lilly and Company as an employee. Dr. Zhang has received personal compensation for activities with Eli Lilly and Company as an employee. J. Ahl has received personal compensation for activities with Eli Lilly and Company as an employee. Dr. Martinez has received personal compensation for activities with Eli Lilly and Company as an employee. Dr. Martinez holds stock and/or stock options in Eli Lilly and Company.