Lilly's Emgality Demonstrates Significant Reduction in Total Pain Burden for Episodic and Chronic Migraine Patients

Compiled by Keke

Currently, in the emerging field of CGRP-targeted migraine prophylactics, Eli Lilly is competing with Amgen, Teva, and Lundbeck. The latest data released by Eli Lilly demonstrate that Emgality can reduce the “total pain burden” in patients with migraine.

On June 17, Eli Lilly announced that Emgality (galcanezumab-gnlm) demonstrated a reduction in the overall pain burden for patients with episodic and chronic migraine in its latest analysis. The overall pain burden is a composite measure encompassing monthly migraine frequency, duration, and pain severity. Furthermore, the overall pain burden was significantly correlated with patient function and quality of life. Emgality is the first and currently only preventive CGRP medication for migraine to be evaluated in this manner, providing more comprehensive data support on how Emgality reduces the frequency, duration, and severity of migraines.

Gudarz Davar, M.D., Vice President of Neurology Development at Eli Lilly Biopharmaceuticals, stated, “The Total Pain Burden metric goes beyond the current limited methods for describing migraine. We believe that assessing migraine from the perspective of total pain burden provides both patients and physicians with a more comprehensive approach to discussing individual pain experiences.”

This post hoc analysis of Emgality versus placebo utilized data from three randomized, double-blind, placebo-controlled clinical trials: two 6-month integrated studies (EVOLVE-1 and EVOLVE-2) in patients with episodic migraine and one 3-month clinical trial (REGAIN) in patients with chronic migraine. Patients reported headache frequency, duration, and severity via electronic diaries. The monthly total pain burden, defined as severity-weighted duration, was calculated by multiplying the number of migraine hours recorded on each migraine day by the pain severity score (0 = none, 1 = mild, 2 = moderate, 3 = severe) and summing these composite measures across all migraine days within a month. A mixed model for repeated measures (MMRM) was employed to compare the least squares (LS) mean changes from baseline in monthly total pain burden over months 1–6 for episodic migraine and months 1–3 for chronic migraine. Additionally, the correlations between the Migraine-Specific Quality of Life Questionnaire (MSQ) and the Migraine Disability Assessment Scale (MIDAS) scores and the total pain burden at baseline were evaluated.

The overall baseline mean monthly total pain burden scores for the episodic migraine and chronic migraine groups were 124.3 and 320.4, respectively. Comparison of the mean change from baseline in total monthly pain load revealed that patients in the Emgality group had significantly fewer monthly pain severity-weighted hours than those in the placebo group (p<0.0001). Among patients with episodic migraine, the mean monthly pain severity-weighted hours decreased by 68.6 hours in the Emgality group compared with 36.2 hours in the placebo group (95% CI: 24.2–40.3). Among patients with chronic migraine, the mean monthly pain severity-weighted hours decreased by 102.6 hours in the Emgality group compared with less than 44.4 hours in the placebo group (95% CI: 37.1–79.3). Furthermore, total pain burden was correlated with the MSQ total score (r=-0.35 and r=-0.37) and MIDAS (r=0.34 and r=0.32) in both the episodic and chronic migraine populations.

Migraine is a neurological disorder characterized by recurrent episodes of moderate to severe headache accompanied by other symptoms, including nausea, photophobia, and phonophobia. In the United States, more than 30 million adults suffer from migraines, with women being three times more likely to be affected than men. According to surveys conducted by the Medical Expenditure Panel Survey (MEPS), the total annual healthcare costs associated with migraines are estimated to reach as high as $56 billion, yet the condition remains underrecognized and undertreated.

Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). It was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. Emgality is the only CGRP monoclonal antibody that achieves responder rates of 50%, 75%, and 100% reduction in monthly migraine days from baseline over 1–6 months in patients with episodic migraine. In June 2019, Emgality was further approved by the FDA for the treatment of episodic cluster headache in adults.

Currently, Eli Lilly is planning an observational study named “Triumph” to evaluate the reduction in overall pain burden after two years of Emgality use. This study will review the real-world efficacy of Emgality compared with other migraine preventive regimens, including patients who are initiating new medications or switching from other therapies to Emgality.

Reference Source: Emgality^® Demonstrates Reduction in Frequency, Duration, and Pain Severity in Patients with Episodic and Chronic Migraine