Eptinezumab reduced migraine effects for adults with previous treatment failures
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For adults with migraine and repeated preventive treatment failures, eptinezumab produced significant reductive effects compared with placebo, along with acceptable safety and tolerability, per a study published in Lancet Neurology.
“Preventive treatment for migraine is recommended for patients for whom migraine attacks cause substantial functional impairment and reduced health-related quality of life,” Messoud Ashina, MD, of the Danish Headache Center, department of neurology at the University of Copenhagen, and colleagues wrote.
Ashina and fellow researchers sought to evaluate safety and efficacy of eptinezumab — a monoclonal antibody that targets calcitonin gene-related peptide — to prevent migraines in adults who endured two to four prior preventive treatment failures within the previous 10 years.
The DELIVER study was a multicenter, multi-arm, phase 3b trial that consisted of a 24-week double-blind, placebo-controlled period and a 48-week dose-blinded extension.
Between June 2020 and October 2021, 891 individuals with episodic or chronic migraine and at least 4 monthly migraine days were recruited from 96 study locations across Europe and the United States. Patients were randomly assigned on a 1:1:1 basis to eptinezumab in doses of 100 mg and 300 mg, or placebo. The primary efficacy endpoint was a change in mean monthly migraine days from study commencement (captured with a daily electronic diary) in weeks 1 to 12 assessed in the full analysis set. The dose-blinded extension period is ongoing.
Results showed that 865 patients completed the placebo-controlled period. The change from baseline to weeks 1 to 12 in mean monthly migraine days was –4.8 (standard error [SE] 0.37) with eptinezumab 100 mg, –5.3 (SE 0.37) with eptinezumab 300 mg and –2.1 (SE 0.38) with placebo. The difference from placebo in change in mean monthly migraine days from baseline was significant with 100 mg of eptinezumab (–2.7 [95% CI, –3.4 to –2]) as well as 300 mg (–3.2 [95% CI, –3.9 to –2.5]).
Treatment-emergent adverse events occurred in 127 of 299 patients in the eptinezumab 100 mg group, in 120 of 294 in the eptinezumab 300 mg group and in 119 of 298 in the placebo group. The most common treatment-emergent adverse event was COVID-19 (20 of 299 patients in the eptinezumab 100 mg group, 17 of 294 in the eptinezumab 300 mg group and 16 of 298 in the placebo group). Serious adverse events were uncommon across all three doses, which included anaphylactic reaction (eptinezumab 300 mg n = 2) and COVID-19 (eptinezumab 100 mg n = 1; eptinezumab 300 mg n = 1).
“Our results show that eptinezumab is efficacious compared with placebo for the preventive treatment of migraine ... with an acceptable safety and tolerability profile similar to that previously reported,” Ashina and colleagues wrote.