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Results from a phase 3 study showed that galcanezumab-gnlm (Emgality, Eli Lilly) significantly improved work productivity and health and well-being between migraine attacks.
Results from a phase 3 study showed that galcanezumab-gnlm (Emgality, Eli Lilly) significantly improved work productivity and health and well-being between migraine attacks for patients with a history of preventive treatment failure, according to a press release.
Galcanezumab-gnlm, a monoclonal antibody that selectively binds to calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults and for the treatment of episodic cluster headache in adults.
The phase 3 CONQUER study evaluated the efficacy and safety of galcanezumab-gnlm for the preventive treatment of episodic and chronic migraine in patients with documented previous treatment failures on 2 to 4 different standard-of-care preventive medication categories. The results were presented virtually at the 6th European Academy of Neurology Congress.
A total of 462 patients were randomized to the galcanezumab-gnlm treatment group or placebo group. Absenteeism, presenteeism (impairment while working), overall work productivity loss, and activity impairment were measured using the migraine-specific Work Productivity and Activity Impairment Questionnaire. The burden between headache attacks (interictal burden) in 4 key areas, including disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty, was measured using the Migraine Interictal Burden Scale (MIBS), which is a 12-point scale.
According to the results, there were statistically significant improvements in work productivity and reductions in overall work productivity loss for patients in the galcanezumab-gnlm treatment group compared with placebo (-14.3% vs -3.5%; P<0.01). The findings also pointed to statistically significant improvements in presenteeism (-12.5% versus -2.6%; P<0.01). Absenteeism was low and not significantly different between groups, according to the study. Non-work-related activity impairment was also statistically significantly reduced in the galcanezumab-gnlm treatment group compared with placebo (-20.7% versus -8.6%; P<0.01). These results were similar in the subgroups of patients with episodic or chronic migraine.
Moreover, the average change in MIBS from a baseline of 5.5 (indicative of severe burden in the time between migraine attacks) was statistically significantly greater in patients receiving galcanezumab-gnlm compared with placebo (-1.8 versus -0.8, respectively; P<0.0001), the results showed.
Among patients with episodic migraine, the most common categorization of MIBS at month 3 was “none” for patients treated with galcanezumab-gnlm versus “severe” for placebo-treated patients, according to the results. Additionally, among patients with chronic migraine, fewer patients treated with galcanezumab-gnlm had “severe” interictal burden per MIBS at month 3, with twice as many galcanezumab-gnlm-treated patients reporting “mild” interictal burden when compared with placebo.