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.

Eptinezumab improved patient‐reported outcomes and quality of life in patients with migraine and prior preventive treatment failures

“…Benefits of treatment with eptinezumab, as measured by the four-item Migraine Treatment Optimization Questionnaire, were particularly pronounced in patients with poor acute treatment optimization at the start of the study [37]. In PREVAIL, eptinezumab administration for up to 1 year was associated with reduced disability (Migraine Disability Assessment) and impact (HIT-6) and improved PI-MBS and disease status (PGIC) [21,38]. A direct relationship between the PI-MBS and PGIC was also observed in the PROMISE-2 study, throughout which the improvement on both scales was strongly correlated [30].…”

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).…”

Chronic Migraine as a Primary Chronic Pain Syndrome and Recommended Prophylactic Therapeutic Options: A Literature Review

“…The post-hoc analysis of the PREVAIL study aimed to investigate the changes in the MIDAS questionnaire over 2 years in eptinezumab-treated CM patients. The mean MIDAS scores evaluating the absenteeism related to missed work/school, household work, and family/social/leisure activities changed from 9.7 days at baseline to 3.2 days at week 12 and to 3.9 days at week 104, whereas those measuring the presenteeism of reduced productivity in work/school or household work changed from 14.2 days at baseline to 5.2 days at weeks 12 and 104 [ 117 ].…”