The following is a summary of “Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial,” published in the November 2023 issue of Pain by Ashina et al.
The DELIVER clinical trial’s placebo-controlled phase demonstrated eptinezumab’s efficacy in adults with migraine and prior preventive treatment failures, but its long-term effectiveness remains unclear.
Researchers conducted a 48-week extension study to evaluate the long-term effectiveness of eptinezumab in migraine patients who previously participated in the DELIVER clinical trial.
They conducted DELIVER from June 1, 2020, to September 15, 2022, treating 865 adults with migraine, previously experiencing 2–4 preventive treatment failures, with eptinezumab (100 or 300 mg) during the dose-blinded extension. Participants either stuck to their dose or if on placebo, were randomly assigned to eptinezumab (1:1 ratio, 100 or 300 mg). Monthly migraine day (MMD) changes from baseline were assessed with a repeated measures mixed model.
The results showed 865 patients in the extension (eptinezumab 100 mg, n = 433; 300 mg, n = 432), 90.4% (782) completed the study, and 1.3% (11) discontinued due to adverse events. Eptinezumab reduced migraine frequency, starting with a mean baseline of about 14 days for MMDs across groups. During the final dosing interval (weeks 61–72), the mean (standard error) change from baseline in MMDs was −6.4 (0.50) with placebo/eptinezumab 100 mg, –7.3 (0.49) with placebo/eptinezumab 300 mg, –7.1 (0.39) with eptinezumab 100 mg, and −7.0 (0.39) with eptinezumab 300 mg. From weeks 61 to 72, 63–70% of patients achieved ≥ 50% reduction in MMDs, and 36–45% demonstrated ≥ 75% reduction. Improvements were observed in headache severity, medication use, and various patient-reported outcomes, including bothersome symptoms, disease status, quality of life, and work productivity. Adverse events were mild, transient, and consistent with prior eptinezumab trials in frequency and type.
They concluded that eptinezumab effectively prevented migraines in patients with prior treatment failures, supporting its long-term use.
Source: thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-023-01688-w
