10 - Efficacy of Galcanezumab in Adults with Treatment Resistant Migraine and Concomitant Pain Disorders: Post-hoc Subpopulation Analyses from the Randomized, Double-Blind, Placebo-Controlled CONQUER Study
Charles Argoff1, Yan Dong2, Lily Li2, Peter Wright2, Meredith Barad3
1Albany Medical College, New York, USA. 2Eli Lilly and Company, Indianapolis, USA. 3Stanford University, Stanford, USA
Purpose Patients with migraine frequently report comorbid pain conditions. The objective of the analyses reported in this abstract was to examine the efficacy of galcanezumab (GMB) compared to placebo (PBO) in patients with treatment-resistant episodic or chronic migraine who had 1 or more concomitant pain disorders. Treatment resistance was defined as previous failure with 2 to 4 standard-of-care migraine preventive medication categories in the past 10 years due to inadequate efficacy and/or safety/tolerability reasons. Methods The CONQUER study was a Phase 3, randomized, double-blind, placebo-controlled study of galcanezumab in adults with treatment-resistant episodic or chronic migraine as defined by IHS ICHD-3 guidelines. In this study, patients with treatment-resistant migraine were randomized 1:1 to receive GMB 120 mg/month (with 240-mg loading dose) or PBO during a 3 month double-blind period. Subpopulation analyses were performed on patients enrolled in this study who had 1 or more concomitant pain disorders; acute pain from surgery, procedures, or fractures was excluded. Assessments of migraine and headache-related endpoints were based on headache information captured via an electronic (ePRO) diary. The following endpoints were evaluated for Months 1–3: 1) change from baseline in number of monthly migraine headache days; 2) response rates for ≥50%, ≥75%, or 100% reduction in monthly migraine headache days; 3) change from baseline in Migraine Specific Quality of Life - Role Function Restrictive (MSQ-RFR) domain score using mixed model with repeated measures. Results Patients who had 1 or more pain disorders (N=100 GMB and N=97 PBO) showed the GMB and PBO groups had similar baseline characteristics. While the most commonly experienced pain disorders were back pain, osteoarthritis, and neck pain, the analyses included many disorders. In this subpopulation, GMB-treated patients had significantly greater mean reduction in the number of monthly migraine headache days during the double-blind treatment phase (Months 1, 2, and 3) compared to patients who received PBO (least square mean difference from placebo at Month 1: -2.37 days, p<.001, Month 2: -1.81 days, p<.05, and Month 3: -2.34 days, p<.01). GMB-treated patients had significantly higher 50% and 100% response rates compared to PBO at Month 1 (p<.001 and p<.0001, respectively) and Month 3 (p<.01 and p<.0001, respectively); these response rates were numerically higher in GMB-treated patients at Month 2, but were not statistically significant. GMB-treated patients also had numerically higher 75% response rates than PBO patients at Months 1–3; however, the difference was not statistically significant. The mean improvement from baseline in MSQ-RFR scores at Months 1, 2, and 3 was significantly greater in the GMB treatment group compared to PBO (least square mean difference from placebo at Month 1: 11.64, p<.0001; Month 2: 10.28, p<.001, and Month 3: 12.01, p<.0001), reflecting better health status and functional improvement. Conclusions GMB 120 mg/month demonstrated superior efficacy to PBO for the preventive treatment of treatment-resistant migraine in patients with 1 or more concomitant pain disorders.