Galcanezumab (Emgality; Eli Lilly, Indianapolis, IN) reduced total pain burden in a recent analysis of individuals with episodic and chronic migraine. Total pain burden is a patient-centric measure that combines the monthly frequency, duration, and pain severity of migraine. Also, total pain burden demonstrated significant associations with patient functioning and quality of life.
This posthoc study of galcanezumab vs placebo used data from 3 randomized, double-blind studies in participants with episodic migraine (2 pooled 6-month studies, EVOLVE-1 [NCT02614183] and EVOLVE-2 [NCT02614196]; galcanezumab n=435, placebo n=872) and chronic migraine (one 3-month study, REGAIN [NCT02614261]; galcanezumab n=273, placebo n=535). Participants reported their headache frequency, duration, and severity using an electronic diary. Monthly total pain burden was calculated as severity-weighted duration by multiplying hours of migraine recorded and pain severity for each migraine day and summing these composite measurements over the migraine days in a month.
The average change from baseline in monthly total pain burden was compared between galcanezumab- and placebo-treated groups. Participants on galcanezumab experienced statistically fewer severity-weighted hours of pain than at baseline at each month compared with participants on placebo (P<.0001 for each comparison). Participants with episodic migraine treated with galcanezumab experienced 32.3 fewer severity-weighted hours of pain per month than those treated with placebo (95% CI, 24.2-40.3). In participants with chronic migraine, those treated with galcanezumab had 58.2 fewer hours of severity-weighted pain compared with those treated with placebo (95% CI, 37.1-79.3).
"Total pain burden moves beyond the current and somewhat limited approach for describing migraine pain," said Gudarz Davar, MD, vice president, neurology development, Lilly Bio-Medicines. "We're delighted that Emgality reduced the combined impact of migraine frequency, duration, and pain severity. We believe that viewing migraine through the lens of total pain burden provides a more holistic approach for people with migraine and doctors to discuss the personal pain experience."
Claire Smyth, BSc; David Roberts, BSc; and Kenneth Monaghan, PhD
Chen Zhao, MD; Claire Flaherty, PhD; Paul J. Eslinger, PhD; and Krishnankutty Sathian, MBBS, PhD
Michael S. Cartwright, MD, MS, and Hwajin Lee, MD