Treatment with galcanezumab (Emgality; Eli Lilly) was associated with improvements in total pain burden for patients with both chronic and episodic migraine compared to placebo groups.
Jessica Ailani, MD
For patients with both episodic and chronic migraine, greater reductions in total pain burden were reported by those treated with once-monthly 120-mg galcanezumab (Emgality; Eli Lilly) compared to those given placebo, according to a new analysis of the results of 3 studies of the headache disorder presented at the American Headache Society (AHS) virtual annual scientific meeting.1
Overall, the mean total monthly pain burden scores for the 2 groups of patients—episodic migraine (n = 1307) and chronic migraine (n = 808)—decreased further with galcanezumab 120 mg in patients with episodic (68.6) and chronic migraine (102.6) than the placebo groups (36.2 and 44.4, respectively). The mean difference between the groups and placebo was 32.3 (95% CI, 24.2—40.4) and 58.2 (95% CI, 37.1–79.3), respectively. The mean change from baseline in monthly total pain burden for those on galcanezumab was statistically lower, with fewer severity-weighted hours of pain at each month compared with those on placebo (P <.0001 for all).
For those with episodic migraine, the galcanezumab group experienced 68.6 fewer severity-weighted hours of pain per month, compared to those on placebo who experienced 36.2 fewer hours (difference, 32.3 hours; 95% CI, 24.2—40.3). For patients with chronic migraine, the galcanezumab group experienced 102.6 fewer severity-weighted hours of pain per month, compared to those on placebo who experienced 44.4 fewer hours of pain (difference, 58.2 severity-weighted hours; 95% CI, 37.1–79.3).
"The impact of migraine is profound, and individualized management goes beyond how many days per month a person experiences migraine. Total pain burden serves as a more comprehensive measure and provides a deeper understanding for us and our patients to describe their pain," said study author Jessica Ailani, MD, director, MedStar Georgetown Headache Center, professor of clinical neurology, Georgetown University Hospital, in a statement.2. "As a clinician, I'm pleased that Emgality may help my patients achieve their preventive treatment goals. I am excited the results of this study show a positive impact on the cumulative burden of frequency, duration, and pain severity of migraine."
The total pain burden—calculated as severity-weighted duration by multiplying migraine duration in hours with maximum pain severity (0 = none; 1 = mild; 2 = moderate; 3 = severe) for each day, summed over the days in a month—in the study populations correlated with both Migraine Specific Quality of Life Questionnaire (MSQ) total score (episodic: r = ‑0.35; chronic: r = -0.37) and Migraine Disability Assessment Scale (MIDAS) score (episodic: r = 0.34; chronic: r = 0.32).
The post-hoc analysis included patients with episodic migraine in 2 pooled 6-month studies, EVOLVE-1 (NCT02614183) and EVOLVE-2 (NCT02614196), which accounted for 435 galcanezumab-treated patients and 872 patients on placebo. Those with chronic migraine participated in a 3-month study, REGAIN (NCT02614261), in which 273 were randomized to galcanezumab and 535 were assigned placebo.
Earlier in the year, results presented virtually at the 6th European Academy of Neurology (EAN) Congress from the phase 3 CONQUER study (NCT03559257) of galcanezumab demonstrated the treatment’s ability to significantly improve work productivity and reduced interictal burden, defined as health and well-being between migraine attack, in patients with migraine and a history of preventive treatment failure.3,4
A total of 97.6% of the patients completed the 3-month double-blind phase, with mean reductions of Work Productivity and Activity Impairment Questionnaire (WPAI) scores from baseline significantly greater (all P ≤.004) in the galcanezumab-treated group (n = 232) compared with placebo (n = 230) in the percent of activity impairment (20.7% vs. 8.6%).
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1. Ailani J, Andrews JS, Rettiganti M, Nicholson R. Impact of Galcanezumab on Total Pain Burden: Findings from Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies in Patients with Episodic or Chronic Migraine. Headache. 2020;60(S1 suppl). 1-156. doi: 10.1111/head.13854
2. Emgality® Demonstrates Reduction in Frequency, Duration, and Pain Severity in Patients with Episodic and Chronic Migraine [press release]. Indianapolis, IN. Eli Lilly. Published June 17, 2020. Accessed July 9, 2020. prnewswire.com/news-releases/emgality-demonstrates-reduction-in-frequency-duration-and-pain-severity-in-patients-with-episodic-and-chronic-migraine-301078159.html
3. Emgality shows improvement in work productivity and health and well-being between attacks in patients with migraine and a history of preventive treatment failure [news release]. Indianapolis, IN: Eli Lily. Published May 26, 2020. Accessed June 3, 2020. prnewswire.com/news-releases/emgality-shows-improvement-in-work-productivity-and-health-and-well-being-between-attacks-in-patients-with-migraine-and-a-history-of-preventive-treatment-failure-301064634.html
4. Garcia-Azorin D, Ford J, Buse D, Hand A, Wietecha L, Detke H. Changes in work productivity and interictal burden: results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcenezumab in adults with treatment-resistant migraine (CONQUER). Eur J Neurol. 2020. EPR1100.