Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab

Abstract

Background: Eptinezumab is an anti-calcitonin gene-related peptide humanized monoclonal antibody approved for the preventive treatment of migraine in adults. The PREVAIL study demonstrated a favorable safety profile with sustained reductions in overall migraine-related burden in patients with chronic migraine (CM). This post hoc analysis aimed to examine item-level changes in the Migraine Disability Assessment (MIDAS) questionnaire over 2 years in participants with CM on eptinezumab treatment.

Methods: PREVAIL was an open-label, phase 3 trial that included 96 weeks of treatment where 128 adults received intravenous eptinezumab administered over 30 min every 12 weeks (wks) for up to 8 doses of 300 mg. MIDAS was administered at baseline, Wk12, and every 12wks thereafter. Two supplementary MIDAS items not included in the total score calculation assessed number of headache days in the past 3 months (MIDAS headache) and average headache pain severity (from 0 [none] to 10 [worst]). MIDAS total scores were summed from 5 items, each quantifying the number of days in the past 3 months with migraine-related disability. Items 1, 3, and 5 assessed absenteeism, namely how many days the patient missed work/school (Q1), household work (Q3), or family/social/leisure activities (Q5). Items 2 and 4 were measures of presenteeism, namely how many days the patient had reduced productivity in work/school (Q2) or household work (Q4).

Results: Mean MIDAS headache days decreased from 47.4 (baseline) to 17.1 (Wk12) and 16.3 (Wk104). The average headache pain severity score (0‒10) decreased from a mean of 7.3 (baseline) to 5.5 (Wk12) to 4.5 (Wk104). Mean MIDAS scores measuring absenteeism (Q1, 3, 5) changed from 9.7 days at baseline to 3.2 days (Wk12) and to 3.9 days (Wk104). Mean MIDAS scores measuring presenteeism (Q2, 4) at Wk12 decreased from 14.2 days at baseline to 5.2 days (Wk12, 104). Patients categorized with very severe MIDAS disability had a mean total MIDAS score of 84.8, with an average reduction of 56.7 days (Wk12), which was maintained at 32 days at Wk104.

Conclusions: Long-term treatment with eptinezumab in patients with CM suggested sustained reductions in MIDAS-quantified disability, consistent with the sustained reductions in headache frequency and pain severity.

Trial registration: ClinicalTrials.gov identifier: NCT02985398 .

Keywords: CGRP monoclonal antibody; Chronic migraine; Eptinezumab; Patient-reported outcomes.

Conflict of interest statement

AB has served on advisory boards for AbbVie, Aeon, Alder, Amgen, Biohaven, Eaglet, Eli Lilly, Impel, Lundbeck, Novartis, Promius, Revance, Supernus, and Teva; and has received funding for speaking from AbbVie, Amgen, Avanir, Biohaven, Depomed, Eli Lilly, Impel, Lundbeck, Pernix, Promius, Supernus, and Teva. AE and BE are employees of H. Lundbeck A/S. JH is an employee of Pacific Northwest Statistical Consulting, Inc., a contracted service provider of biostatistical resources for H. Lundbeck A/S. RC was an employee of Lundbeck at the time of manuscript development.

© 2022. The Author(s).

Figures

Fig. 1

MIDAS headache days* across 2 years: A mean headache days ± standard error, and B mean change ± standard error in headache days. MIDAS, Migraine Disability Assessment. *Number of headache days occurring over 3-month (12-week) periods over the course of the trial

Fig. 2

MIDAS pain severity* over 2 years: A mean pain severity score ± standard error, and B mean change in pain severity score ± standard error. MIDAS, Migraine Disability Assessment. *Pain severity graded on 0‒10 scale

Fig. 3

Change from baseline in MIDAS item scores measuring absenteeism* and presenteeism† over 2 years. MIDAS, Migraine Disability Assessment. *Absenteeism comprises the average of Items 1, 3, and 5. Item 1: missed work/school; Item 3: no household work; Item 5: missed family/social/leisure activities. The average at baseline was 9.7 †Presenteeism comprises the average of Items 2 and 4. Item 2: work/school productivity ≤ half; Item 4: household productivity ≤ half. The average at baseline was 14.2

Fig. 4

MIDAS total score ± standard error at baseline, Week 12, Week 84, and Week 104: A total safety population and subgroup with very severe MIDAS disability*, and B patients with < 50%, 50‒74%, or ≥ 75% HRR at Week 12. HRR, headache responder rate assessed by MIDAS; MIDAS, Migraine Disability Assessment. *Level of disability based on MIDAS total score: little or no disability (0–5), mild disability (6–10), moderate disability (11–20), severe disability (21–40), very severe disability (41–270)