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

Study design and patients

Detailed methodology for RELIEF has been published [15]. Briefly, RELIEF was a 4- to 12-week, phase 3, multicenter, parallel-group, double-blind, placebo-controlled clinical trial conducted between November 2019 and July 2020 (NCT04152083) in which patients were randomized to receive eptinezumab 100 mg or placebo. Patients were between the ages of 18–75 years (inclusive) with a ≥ 1-year history of migraine (defined by the International Classification of Headache Disorders, 3rd edition [ICHD-3] criteria [5]), with or without aura, with onset of first migraine before age 50 years, and migraine on 4–15 days per month in the 3 months prior to screening. Patients were required to have typical migraine attacks with a duration of 4–72 h if untreated, with headache pain of moderate to severe intensity and a prespecified most bothersome symptom of nausea, photophobia, or phonophobia. Additionally, patients were required to have a history of either previous or active use of triptans for acute treatment of migraine. Treatment (total volume of 100 mL) was administered intravenously over a period of 30 min on day 0 within 1–6 h of onset of the qualifying migraine attack of moderate to severe intensity.

Outcome measures

Patient-reported outcome measures included the mTOQ-6 and 6-item Headache Impact Test (HIT-6). The mTOQ-6 and HIT-6 were captured at baseline and at week 4. The mTOQ-6 data was transformed into the mTOQ-4 for the purposes of these analyses.

The mTOQ-6 is a self-report questionnaire used to assess the optimization of acute treatment in persons with migraine. The 6 mTOQ items are as follows: (1) “Are you able to quickly return to your normal activities (i.e., work, family, leisure, social activities) after taking your migraine medication?” (2) “Can you count on your migraine medication to relieve your pain within 2 h for most attacks?” (3) Does one dose of your migraine medication usually relieve your headache and keep it away for at least 24 h?” (4) “Is your migraine medication well tolerated?” (5) “Are you comfortable enough with your migraine medication to be able to plan your daily activities?” (6) “After taking your migraine medication, do you feel in control of your migraines enough so that you feel there will be no disruption to your daily activities?” [17]. Each of the 6 items is scored as never (1), rarely (2), less than half the time (3), and half the time or more (4). The mTOQ-6 total score is calculated by summing individual question scores (score range of 6‒24), with higher scores indicating better acute treatment optimization [17].

In addition to the mTOQ-6 scores, the developers provide a simplified scoring for the mTOQ-4 by selecting the items that best assessed treatment efficacy: “2-h pain free,” “24-h relief,” “able to plan,” and “feeling in control” [9]. Items evaluating “tolerability” and “quick return to function” were excluded because they were either unrelated or redundant [9]. For analysis purposes, the item scores were classified (combining rarely and less than half the time) and new scores were assigned as never (0), rarely (0), less than half the time (1), and at least half the time (2), and then summed for total score. Patients were then grouped by baseline mTOQ-4 total scores into the following optimization categories: very poor (0), poor (1–5), moderate (6–7), and maximal (8). A simplified grouping combined very poor with poor (0–5) and moderate with maximal (6–8).

The HIT-6 is a self-reported assessment of the impact on the ability to function normally in daily life when a headache occurs [18]. Each of the 6 items is scored as never (6), rarely (8), sometimes (10), very often (11), and always (13). The HIT-6 total score is calculated by summing individual items (score range of 36‒78 points), with the total score representing headache-related life impact: severe impact =  ≥ 60, substantial impact = 56–59, some impact = 50–55, and little to no impact =  ≤ 49.

Statistical analysis

For the mTOQ-6 and HIT-6, total scores were summarized by treatment group at baseline and week 4 (or early termination) and change from baseline to the week 4 visit was calculated. If response was missing for ≥ 1 item of the HIT-6 or mTOQ-6, the respective total score was treated as missing; no missing data were imputed. As a post hoc analysis, all results are summarized descriptively.

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