Non-work-related activity impairment was statistically significantly reduced in the galcanezumab group compared to placebo.
David Garcia-Azorin, MD, MSci
Results presented virtually at the 6th European Academy of Neurology (EAN) Congress from the phase 3 CONQUER study (NCT03559257) of galcanezumab (Emgality; Eli Lilly) 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.1,2
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%).
Other assessments on the WPAI such as presenteeism (12.5% vs 2.6), and overall work impairment (14.3% vs 3.5%) were significantly greater in galcanezumab compared with placebo. Notably, absenteeism was not significantly different.
"This study showed that Emgality improved workplace productivity and decreased impairment between attacks, both important outcomes for patients. Given the disabling effects of migraine, Emgality is an option that may help patients achieve the treatment goals that matter to them,” David Garcia-Azorin, MD, MSci, Valladolid University Hospital Headache Clinic, said in a statement.
Additional results from the study showed that the mean change from baseline of 5.5 on the Migraine Interictal Burden Scale (MIBS), which ranges from burden between attacks from 0 to 12, 0 being non, >5 being severe, was greater for the galcanezumab group (1.8) compared with placebo (0.8; P <.0001).
The double-blind phase 3 study randomized 462 patients to 120 mg per month galcanezumab (with a 240 mg loading dose) or placebo across a 3-month stretch. Absenteeism, presenteeism, work productivity loss, and activity impairment were all assessed using WPAI and calculated as impairment percentages.
Led by Garcia-Azorin, the study aimed to evaluate changes in work productivity and activity impairment along with interictal burden attributed to migraine among patients treated with galcanezumab or placebo.
Previous data from CONQUER showed that patients who had previous failures with standard migraines who received the 120-mg monthly dose of galcanezumab demonstrated an average of 4.1 fewer monthly migraine headache days from a baseline of 13.4, compared to an average of 1.0 fewer from a baseline of 13.0 in patients with placebo (between-group difference: -3.1; 95% CI, —3.9 to –2.3; effect size, .72; P <.0001).3
In addition to reduced monthly migraine headache days, the treatment proved to be superior to placebo in all other secondary end points and demonstrated a safe tolerable profile that was consistent with previous studies.
The FDA originally approved galcanezumab as an injection formulation for preventive migraine treatment in September 2018. Less than a year later, in June 2019, it became the first FDA approved therapy for the treatment of episodic cluster headache in adults.4 The humanized monoclonal antibody against calcitonin gene-related peptide (CGRP) was designated for priority review by the agency and was also given a breakthrough therapy label in fall of 2018.
1. 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
2. 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.
3. Mulleners W, Kim BK, Lainez M, et al. A randomized, placebo-controlled study of galcanezumab in patients with treatment-resistant migraine: double-blind results from the CONQUER study. Neurology. 2020;94(15 Suppl): 0162.
4. FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks [press release]. Silver Spring, MD: FDA. Published June 4, 2019. fda.gov/news-events/press-announcements/fda-approves-first-treatment-episodic-cluster-headache-reduces-frequency-attacks. Accessed June 4, 2019.