Optimization of Acute Treatment and Headache-Related Impact Following Eptinezumab Initiated During a Migraine Attack: Post Hoc Analysis of the RELIEF Study
Dawn C. Buse1,2, Richard B. Lipton1, Anders Ettrup3, Mette Krog Josiassen3, Annika Lindsten3, Roger Cady4
1Department of Neurology, Albert Einstein College of Medicine, 2Vector Psychometric Group, LLC, 3H. Lundbeck A/S, 4Lundbeck LLC, Deerfield, IL
Objective:
To investigate the impact of eptinezumab—an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention—on acute medication optimization.
Background:
Patients administered eptinezumab during an active migraine had larger numerical improvement in the 6-item Migraine Treatment Optimization Questionnaire (mTOQ-6) total score compared to placebo. The mTOQ-6 was used to determine success of acute treatment. Previous research validated optimization levels determined by the mTOQ-4, which comprises 4 of the mTOQ-6 items best assessing treatment efficacy.
Design/Methods:
RELIEF (NCT04152083) was a double-blind trial that randomized adults eligible for preventive migraine treatment to eptinezumab 100mg or placebo, administered intravenously within 1–6 hours of migraine onset. mTOQ-6 was captured at baseline and Week 4 and rescored into mTOQ-4 for this post hoc analysis. Patients were grouped by baseline mTOQ-4 total scores into the following optimization categories: very poor (0), poor (1-5), moderate (6-7), and maximal (8), and changes from baseline in mTOQ-6 and 6-item Headache Impact Test (HIT-6) total scores were calculated.
Results:
226 eptinezumab-treated and 232 placebo patients were included. The percentage of patients in the combined very poor and poor optimization subgroups at baseline with eptinezumab (n=155; 68.6%) versus placebo (n=138; 59.5%) decreased by 26.6 percentage points (n=95; 42.0%) and 9.9 percentage points (n=115; 49.6%), respectively, at Week 4. Of the 155 eptinezumab-treated and 138 placebo patients who were very poorly/poorly optimized at baseline, 73 (47.1%) versus 35 (25.4%) were moderately/maximally optimized at Week 4, respectively. Patients reporting very poor baseline optimization demonstrated improvements on HIT-6 total score of ‒11.2 with eptinezumab versus ‒2.2 with placebo from baseline to Week 4. Greater improvements in mTOQ-6 and HIT-6 total scores were noted in patients more poorly optimized at baseline than those more optimized.
Conclusions:
Eptinezumab showed greater acute migraine medication optimization and decreased headache-related impact compared to placebo, suggesting that eptinezumab may work synergistically with acute medications.