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.

Gel-forming antagonist provides a lasting effect on CGRP-induced vasodilation

“…Compared to the placebo group, CGRP antibody therapies resulted in a reduction of monthly migraine days of 1.44–1.55 days (i.e., in patients who on average have 8–14 migraine headache days per month) ( Deen et al, 2017 ; Tso and Goadsby, 2017 ; Tepper, 2018 ; Deng et al, 2020 ; Vandervorst et al, 2021 ). In addition, eptinezumab was shown to increase the proportion of patients with moderate/maximal optimization from 31% at baseline to 58% at week four compared to 40–50% in the placebo group and was associated with improvements in acute medication optimization compared with placebos ( Cady et al, 2022 ). Furthermore, anti-CGRP antibodies were shown to reduce acute migraine-specific medication days of 1.28 days and the use of acute headache medication ( Deng et al, 2020 ; Tepper et al, 2021 ).…”

Nine-Month Continuous Fremanezumab Prophylaxis on the Response to Triptans and Also on the Incidence of Triggers, Hypersensitivity and Prodromal Symptoms of Patients with High-Frequency Episodic Migraine

“…This outcome was quantified with the use of the migraine treatment optimization questionnaire-4 (mTOQ-4), which is a validated self-report questionnaire used to assess the optimization of acute treatment in persons with migraine ranging from 0 to 8 and higher scores indicating better acute medication optimization [19]. For the purposes of the current analysis, the acute treatment optimization grouping was merged to "poorly optimized" ("very poor" (score 0) and "poor" (score 1-5) groups), "optimized" ("moderate" (score 6-7) and "maximal" categories (score 8)), as this was previously applied elsewhere [20]; (ii) proportion of individual hypersensitivity symptoms accompanying headache [21], including osmophobia (dislike or aversion to smell or odors), photophobia (sensitivity or aversion to light), phonophobia (sensitivity or aversion to sounds), nausea/vomiting (urge to vomit/forceful ejection of the contents of the stomach through the mouth) and allodynia, i.e., pain generated after applying a non-noxious stimulus. For this cluster of the analysis, patients also provided numerical data concerning the changes in the average days with the specific symptoms between followups; (iii) proportion of individual prodromal symptoms (premonitory symptoms that often precede a migraine attack), including mood changes, yawning, somnolence, drowsiness, food craving, neck stiffness and fatigue [22]; and (iv) presence of triggers followed by headache (endogenous or exogenous stimuli that lower the threshold for the onset of an attack in migraine-predisposed patients), including stress, irregular sleep schedule, specific food consumption, alcohol/caffeine intake, weather changes, dehydration and also luminous and olfactory stimuli [23].…”

Eptinezumab for the preventive treatment of episodic and chronic migraine: a narrative review

“…Efficacy was maintained up to week 48 (year 1), with a significant reduction in the MMDs after the second (weeks [13][14][15][16][17][18][19][20][21][22][23][24], third (weeks [25][26][27][28][29][30][31][32][33][34][35][36], and fourth (weeks 37-48) infusions (52). Overall, the percentage of patients with a ≥ 50% or ≥ 75% reduction in MMDs up to week 48 was higher with eptinezumab than with placebo.…”

“…During recent months, a large number of results from post-hoc analyses of data from eptinezumab pivotal trials (17,18) has been published (19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30), together with primary and post-hoc results from the DELIVER trial (31)(32)(33)(34). Also, numerous clinical trials on eptinezumab are currently being conducted (35)(36)(37)(38)(39)(40)(41)(42).…”