Eptinezumab for migraine prevention in patients 50 years or older

Abstract

Objective: To evaluate the efficacy and safety of eptinezumab versus placebo in patients ≥50 years old with episodic (EM) or chronic migraine (CM). Materials and Methods: This post hoc analysis included data from two phase 3, parallel-group, randomized, double-blind, placebo-controlled studies in adults with EM (PROMISE-1) or CM (PROMISE-2). Patients ≥50 years at baseline treated with eptinezumab 100 mg, 300 mg, or placebo were pooled from both studies to evaluate efficacy and safety. Results: A total of 385/1960 (19.6%) EM and CM patients who were ≥50 years old at baseline (range, 50–71 and 50–65 years, respectively) received eptinezumab 100 mg (n = 132), 300 mg (n = 127), or placebo (n = 126) over Weeks 1–12. Reductions in mean monthly migraine days (MMDs) in ≥50-year-old EM patients were –3.8 (100 mg) and –4.4 (300 mg) with eptinezumab versus –2.6 with placebo. In ≥50-year-old CM patients, mean changes in MMDs were –7.7 (100 mg) and –8.6 (300 mg) with eptinezumab versus –6.0 with placebo. Changes in MMDs were comparable to total study results. A ≥50% MMD reduction over Weeks 1–12 was achieved by 57.9% of eptinezumab-treated versus 35.7% of patients who received placebo, and a ≥75% reduction by 30.5% versus 13.5%, respectively. The incidence of treatment-emergent adverse events (TEAEs) in EM and CM patients ≥50 years old was similar across treatment groups, with ≥96% of TEAEs mild or moderate in severity. Conclusions: Treatment with eptinezumab was efficacious, tolerable, and safe in patients ≥50 years with EM or CM, congruent with results from the overall study population.