Eptinezumab for migraine prevention in patients 50 years or older

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.

Automated summary

This study evaluated the efficacy and safety of eptinezumab in patients aged 50 and above with episodic or chronic migraine. The results showed that eptinezumab significantly reduced the number of migraine days and had a good safety profile.