Optimization of acute medication use following eptinezumab initiation during a migraine attack: post hoc analysis of the RELIEF study

Abstract

Background: The benefits of preventive treatment on the effectiveness of migraine management have rarely been examined. This post hoc analysis investigated the impact of eptinezumab on the optimization of acute medication effectiveness using the 4-item Migraine Treatment Optimization Questionnaire (mTOQ-4) to measure acute medication optimization over 4 weeks post-infusion.

Methods: RELIEF was a 12-week, phase 3, multicenter, parallel-group, double-blind, placebo-controlled clinical trial conducted in patients aged 18-75 years with a ≥ 1-year history of migraine and 4-15 migraine days per month in the 3 months prior to screening. Patients were randomized 1:1 to a 30-min infusion of eptinezumab 100 mg or placebo within 1-6 h of a qualifying migraine attack. The mTOQ-6 and 6-item Headache Impact Test (HIT-6) were administered at screening visit and week 4. From the mTOQ-6, we calculated the mTOQ-4 using the following items: "2-h pain free," "24-h relief," "able to plan," and "feeling in control" to measure acute medication optimization.

Results: A total of 238 patients received eptinezumab 100 mg and 226 provided week 4 data; 242 received placebo and 232 provided week 4 data. In the eptinezumab arm, the proportion of patients with moderate/maximal optimization increased from 31.4% at baseline to 58.0% (26.6 percentage point increase) at week 4. The corresponding proportions in the placebo group were 40.5% to 50.4% (9.9 percentage point increase). Eptinezumab treatment was associated with numerically larger improvements in HIT-6 at week 4. Relative improvements with eptinezumab vs. placebo from baseline to week 4 in HIT-6 were greater in those with poor treatment optimization at baseline.

Conclusions: In comparison with placebo, treatment with eptinezumab was associated with improvements in acute medication optimization as measured by mTOQ and reductions in headache impact, as measured by HIT-6. These benefits were greater in those with poor acute treatment optimization prior to preventive treatment with eptinezumab.

Trial registration: ClinicalTrials.gov identifier: NCT04152083 .

Keywords: CGRP; Eptinezumab; Migraine; mTOQ.

Conflict of interest statement

Dr. Cady was an employee of Lundbeck at the time of the study.

Dr. Lipton has been a consultant, advisory board member, and/or has received honoraria from Lundbeck Seattle BioPharmaceuticals, Allergan/Abbvie, American Academy of Neurology, American Headache Society, Amgen, Biohaven Pharmaceuticals, electroCore Medical, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Teva Pharmaceuticals, and Vedanta. He holds stock or stock options in Biohaven Pharmaceuticals and Manistee.

Dr. Buse is a part-time employee of Vector Psychometric Group, a company that has received funding from H. Lundbeck A/S for separate research, has received grant support from the US Food and Drug Administration and the National Headache Foundation, has received grant support and honoraria from Allergan, Amgen, Biohaven, Eli Lilly, Novartis, and Teva, and serves on the editorial board of Current Pain and Headache Reports.

Dr. Josiassen, Ms. Lindsten, and Dr. Ettrup are employees of Lundbeck.

© 2022. The Author(s).

Figures

Fig. 1

Distribution of acute medication optimization (mTOQ-4) at baseline and week 4. The mTOQ-4 was derived from the mTOQ-6 by selecting the items that best assessed efficacy: “2-h pain free,” “24-h relief,” “able to plan,” and “in control.” Each item is rated never (1), rarely (2), less than half the time (3), or half the time or more (4). 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). mTOQ-4/mTOQ-6, 4-item/6-item Migraine Treatment Optimization Questionnaire

Fig. 2

Simplified distribution of acute medication optimization (mTOQ-4) at baseline and week 4. The mTOQ-4 was derived from the mTOQ-6 by selecting the items that best assessed efficacy: “2-h pain free,” “24-h relief,” “able to plan,” and “in control.” Each item is rated never (1), rarely (2), less than half the time (3), or half the time or more (4). Poorly optimized comprises the “very poor” and “poor” categories; optimized comprises “moderate” and “maximal.” Simplified subgroups consist of patients with mTOQ-4 total scores in very poor (0) and poor (1–5) categories together, along with patients with total scores in the moderate (6–7) and maximal (8) categories grouped together. mTOQ-4/mTOQ-6, 4-item/6-item Migraine Treatment Optimization Questionnaire

Fig. 3

Change from baseline to week 4 in mTOQ-6 total score by baseline acute treatment optimization subgroup. 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). The mTOQ-6 total score ranges from 6 to 24, with higher scores indicating better acute medication optimization. Epti, eptinezumab (100 mg); mTOQ-4/mTOQ-6, 4-item/6-item Migraine Treatment Optimization Questionnaire

Fig. 4

Change from baseline to week 4 in HIT-6 total score by baseline acute treatment optimization subgroup based on mTOQ-4. 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). The HIT-6 total score ranges from 36 to 78, with higher scores indicating more severe headache-related impact. Epti, eptinezumab (100 mg); HIT-6, 6-item Headache Impact Test; mTOQ-4, 4-item Migraine Treatment Optimization Questionnaire