AHS 2019: Post-Hoc Analyses of Phase 3 Pivotal Studies of Emgality (galcanezumab-gnlm) Show Improvements in Daily Functioning and Reductions in Disability in Patients with Chronic and Episodi
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Results showed that treatment with Emgality, when compared to placebo, resulted in lower levels of migraine-related disability and fewer restrictions on daily activities that are limited by migraine, such as relationships with family and friends, leisure time, productivity, concentration, energy and fatigue(1)
INDIANAPOLIS, July 12, 2019 /PRNewswire/ --?Eli?Lilly and Company (NYSE: LLY) today 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.1 The analyses are based on data from three double-blind, placebo-controlled, Phase 3 pivotal studies of Emgality in chronic (REGAIN) and episodic migraine (EVOLVE-1 & EVOLVE-2).1?The data will be presented today at the 61st Annual Scientific Meeting of the American Headache Society (AHS) in Philadelphia.
"Migraine is the second leading cause of disability in the U.S. and can severely impact people's lives," said Gudarz Davar, M.D., vice president, Neurology Development, Lilly Bio-Medicines.2 "Emgality gives people a chance to reduce their monthly migraine headache days. Given the diverse disability and restrictions imposed by migraine, it is important to understand whether treatments like Emgality can lead to improvements in people's migraine-related disability and restrictions imposed on their daily activities, relationships, productivity and free-time."
Based on the post-hoc analyses:
- 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.1 The MIDAS questionnaire measures headache-related disability as lost time due to headache from paid work or school, household work and nonwork activities.3 The MIDAS disability categories correspond to different levels of limitation and medical need.3
- 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.1
- 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%).1
- 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).1 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.4
- 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.1
- 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.1
- preventive treatment of migraine
- treatment of episodic cluster headache
- Wietecha L, Ford J, Starling A, et al. Patient gains in daily functioning and reductions in disability with galcanezumab among patients with episodic and chronic migraine. Abstract P116. 61st Annual Scientific Meeting of the American Headache Society (AHS), 2019.
- Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. 2017;16:390.
- Lipton RB, Stewart WF, Sawyer J, et al. Clinical utility of assessing migraine disability: the Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2001;41:9.
- Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52:3.
- Katsarava Z, Buse D, Manack A, et al. Defining the differences between episodic migraine and chronic migraine.?Current Pain Headache Reports.?2012;16:86.
- Blumenfeld AM, Payne KA, Varon SF, et al. Disability, HRQOL, and resource use amongst chronic and episodic migraineurs. Results from the International Burden of Migraine Study (IBMS).?Cephalalgia. 2011;31:301.
- Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349.
- Raval AD, Shah A. National trends in direct health care expenditures among US adults with migraine: 2004 to 2013.?Journal of Pain.?2017;57:60.