Post-hoc analyses of phase III pivotal studies of Emgality show improvements in daily functioning and reductions in disability in patients with chronic and episodic migraine

Eli Lilly and Company announced the presentation of post-hoc analyses showing improvements in daily functioning and reductions in disability in patients with chronic and episodic migraine treated with Emgality (galcanezumab-gnlm) compared to placebo. The analyses are based on data from three double-blind, placebo-controlled, Phase III pivotal studies of Emgality in chronic (REGAIN) and episodic migraine (EVOLVE-1 & EVOLVE-2). The data will be presented at the 61st Annual Scientific Meeting of the American Headache Society (AHS) in Philadelphia.

Based on the post-hoc analyses : 1.Greater and statistically significant proportions of patients treated with Emgality showed reductions in disability due to migraine, as measured by the Migraine Disability Assessment (MIDAS), when compared to placebo. The MIDAS questionnaire measures headache-related disability as lost time due to headache from paid work or school, household work and nonwork activities. The MIDAS disability categories correspond to different levels of limitation and medical need. 2. Among patients in the chronic migraine pivotal study (REGAIN), a statistically significant increase of 46.2% was seen in the proportion of patients with "little/no disability" after three months of treatment with Emgality compared to placebo (Emgality 20.3% vs. placebo 13.9%), regardless of baseline disability. 3.In the pooled analysis of the pivotal studies for episodic migraine (EVOLVE-1 and EVOLVE-2), patients with "moderate to very severe disability" at baseline were 66.1% more likely to shift to "little/no disability" after six months of treatment with Emgality compared with placebo, with the difference achieving statistical significance (Emgality 44.0% vs. placebo 26.5%). 4.Treatment with Emgality was associated with improvements across all seven items of the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive Domain (MSQ-RFR). The MSQ-RFR questionnaire measures the degree to which migraine limits a person's daily social and work-related activities, including: feeling more energetic; feeling less tired for work or daily activities; concentrating better on work/daily activities; able to get more done at work and home; less difficulty performing work/daily activities; less interference in leisure activities; and less interference dealing with family and friends. 5.In the REGAIN pivotal study for chronic migraine, patient gains in daily functioning were greater among patients treated with Emgality compared to placebo, for all items of the MSQ-RFR, with most reaching statistical significance. 6. In the pooled analysis of the pivotal studies for episodic migraine (EVOLVE-1 and EVOLVE-2) patient gains in daily functioning were statistically significantly greater among patients treated with Emgality as compared to placebo across all seven items of MSQ-RFR.

Overall, the analyses showed that patients treated with Emgality for the prevention of chronic or episodic migraine showed improvements in migraine-related disability and functional gains in the performance of daily activities that are limited by migraine.