Eptinezumab reduces mean monthly migraine days

In the phase 3 PROMISE-1 trial, efficacy and safety of eptinezumab for the prevention of episodic migraine through 1 year was evaluated. Administered intravenously every 12 weeks, it reduced mean monthly migraine days over weeks 1-12. Additional infusions achieved sustained or incremental reductions [1].

Eptinezumab is a calcitonin gene-related peptide receptor antagonist. In PROMISE-1, eligible adults with episodic migraine were randomised to 4 infusions every 12 weeks of eptinezumab 30 mg, 100 mg, 300 mg, or placebo. The primary endpoint was change in mean monthly migraine days in the first 3 months (see Table). In the efficacy population (n=888) baseline mean monthly migraine days were ~8.5.

Table: Efficacy results of eptinezumab in PROMISE-1 [1]



Also presented were results of the PROMISE-2 trial, investigating the impact of eptinezumab on patient global impression of change (PGIC) and self-reported most bothersome associated symptom (MBAS) in patients with chronic migraine [2]. The efficacy population included 1,072 patients (100 mg, n=356; 300 mg, n=350; placebo, n=366). After 4 weeks, MBAS was much or very much improved in 45.0%, 56.9%, and 28.9% of patients, respectively. PGIC was much or very much improved in 45.0%, 59.0%, and 32.3%, respectively. Improvement was maintained or further improved after 12 and 24 weeks. The similar trends in MBAS and PGIC improvement across time points suggest these are highly correlated.

1. Saper J, et al. AAN 2019, S38.003.
2. Cady R, et al. AAN 2019, S38.009.



Posted on 30 July 201919 November 2021