Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2

Abstract

Background: This post hoc subgroup analysis evaluated the efficacy and safety of eptinezumab for migraine prevention in patients with migraine and self-reported aura.

Methods: PROMISE-1 (NCT02559895; episodic migraine) and PROMISE-2 (NCT02974153; chronic migraine) were randomized, double-blind, placebo-controlled trials that evaluated eptinezumab for migraine prevention. In both studies, the primary outcome was the mean change from baseline in monthly migraine days over Weeks 1-12. Patients in this analysis included those who self-reported migraine with aura at screening.

Results: Of patients with episodic migraine, ∼75% reported a history of aura at screening; of patients with chronic migraine, ∼35% reported a history of aura. Changes in monthly migraine days over Weeks 1-12 were -4.0 (100 mg) and -4.2 (300 mg) with eptinezumab versus -3.1 with placebo in patients with episodic migraine with aura, and were -7.1 (100 mg) and -7.6 (300 mg) with eptinezumab versus -6.0 with placebo in patients with chronic migraine with aura. Treatment-emergent adverse events were reported by 56.0% (100 mg), 57.4% (300 mg), and 55.4% (placebo) of patients.

Conclusions: The preventive migraine efficacy of eptinezumab in patients in the PROMISE studies who self-reported aura was comparable to the overall study populations, demonstrating a similarly favorable safety and tolerability profile.Trial registration: ClinicalTrials.gov Identifiers: NCT02559895 and NCT02974153.

Keywords: Eptinezumab; efficacy; migraine prevention; migraine with aura.

Conflict of interest statement

Declaration of conflicting interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MA is a consultant, speaker, or scientific advisor for AbbVie/Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva; primary investigator for AbbVie/Allergan, Amgen, Eli Lilly, and Lundbeck ongoing trials. MA has no ownership interest and does not own stocks of any pharmaceutical company. MA serves as associate editor of Cephalalgia, associate editor of the Journal of Headache and Pain, and associate editor of Brain.

PM reports receiving personal fees and research support from AbbVie, Amgen/Novartis, Biohaven, Eli Lilly, Lundbeck, and Teva.

RC was an employee at Lundbeck or one of its subsidiary companies at the time of the study and manuscript development.

JH is an employee of Pacific Northwest Statistical Consulting, Inc., a contracted service provider of biostatistical resources for H. Lundbeck A/S.

AE is an employee of H. Lundbeck A/S.

Figures

Figure 1.

Mean change from baseline in MMDs over Weeks 1‒12 in the full study population and subgroup of patients with self-reported history of aura in (a) PROMISE-1 and (b) PROMISE-2.Differences between treatment groups were analyzed using an analysis of covariance model with change from baseline as the response variable and treatment and baseline migraine days as independent variables. MMD, monthly migraine days.*P = 0.0182; **P = 0.0001; ***P 

Figure 2.

Migraine responder rates over Weeks 1–12 in patients with migraine and self-reported history of aura (PROMISE-1 and PROMISE-2 pooled efficacy population).Δ? placebo, difference from placebo (95% confidence interval). MRR, migraine responder rate.

Figure 3.

Mean “any” acute headache medication days per month in patients with migraine and self-reported history of auraa (PROMISE-1 and PROMISE-2 pooled efficacy population).Acute headache medications (AHM) included combination analgesics, ergotamine, opioids, simple analgesics, and triptans.aIf multiple drug classes were taken on a single day, the day was counted once.