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. 2024 Mar 28;25(1):45.
doi: 10.1186/s10194-024-01752-z.

Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab

Linus Jönsson  1 , Susanne F Awad  2 , Stephane A Regnier  3 , Brian Talon  3 , Steven Kymes  3 , Xin Ying Lee  4 , Peter J Goadsby  5   6
Affiliations

Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab

Linus Jönsson et al. J Headache Pain. .

Abstract

Background: As new migraine therapies emerge, it is crucial for measures to capture the complexities of health-related quality of life (HRQoL) improvement beyond improvements in monthly migraine day (MMD) reduction. Investigations into the correlations between MMD reduction, symptom management, and HRQoL are lacking, particularly those that focus on improvements in canonical symptoms and improvement in patient-identified most-bothersome symptoms (PI-MBS), in patients treated with eptinezumab. This exploratory analysis identified efficacy measures mediating the effect of eptinezumab on HRQoL improvements in patients with migraine.

Methods: Data from the DELIVER study of patients with 2-4 prior preventive migraine treatment failures (NCT04418765) were inputted to two structural equation models describing sources of HRQoL improvement via Migraine-Specific Quality-of-Life Questionnaire (MSQ) scores. A single latent variable was defined to represent HRQoL and describe the sources of HRQoL in DELIVER. One model included all migraine symptoms while the second model included the PI-MBS as the only migraine symptom. Mediating variables capturing different aspects of efficacy included MMDs, other canonical symptoms, and PI-MBS.

Results: In the first model, reductions in MMDs and other canonical symptoms accounted for 35% (standardized effect size [SES] - 0.11) and 25% (SES - 0.08) of HRQoL improvement, respectively, with 41% (SES - 0.13) of improvement comprising "direct treatment effect," i.e., unexplained by mediators. In the second model, substantial HRQoL improvement with eptinezumab (86%; SES - 0.26) is due to MMD reduction (17%; SES - 0.05) and change in PI-MBS (69%; SES - 0.21).

Conclusions: Improvements in HRQoL experienced by patients treated with eptinezumab can be substantially explained by its effect on migraine frequency and PI-MBS. Therefore, in addition to MMD reduction, healthcare providers should discuss PI-MBS improvements, since this may impact HRQoL. Health technology policymakers should consider implications of these findings in economic evaluation, as they point to alternative measurement of quality-adjusted life years to capture fully treatment benefits in cost-utility analyses.

Trial registration: ClinicalTrials.gov (Identifier: NCT04418765 ; EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25 ).

Keywords: Eptinezumab; Migraine; Structural equation modeling; Treatment efficacy.

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Conflict of interest statement

Linus Jönsson has received consultancy fees from H. Lundbeck A/S. Susanne F. Awad, Stephane A. Regnier, Brian Talon, and Xin Ying Lee are employees of H. Lundbeck A/S. Stephane A. Regnier owns stock or stock options in Novartis. Steven Kymes was an employee of H. Lundbeck A/S at the time of study and is currently an employee of Ionis Pharmaceuticals. Peter J. Goadsby reports, over the last 36 months, a grant from Celgene, and personal fees from Aeon Biopharma, Allergan/AbbVie, CoolTech LLC, Dr. Reddy’s, Eli Lilly, Epalex, Impel Neuropharma, Lundbeck, Novartis, Pfizer, Praxis, Sanofi, Satsuma, Teva Pharmaceuticals, and Tremeau. He also reports personal fees for advice through Gerson Lehrman Group, Guidepoint, SAI Med Partners, and Vector Metric; fees for educational materials from CME Outfitters, and WebMD; publishing royalties or fees from Massachusetts Medical Society, Oxford University Press, UpToDate, and Wolters Kluwer; fees for medicolegal advice in headache; and a patent for magnetic stimulation for headache (No. WO2016090333 A1) assigned to eNeura without fee.

Figures

Fig. 1
Fig. 1
Structural equation diagrams for (A) Model 1 and (B) Model 2 Shapes: circle = latent variable; square/rectangle = measured variables. Color arrows: green arrows = paths (between variables); blue two-way arrows (between variables) = covariances; gray twoway arrows (variable to itself) = variances Abbreviations: MMDs, monthly migraine days; MSQ, Migraine-Specific Quality of Life Questionnaire; MSQ-EF, MSQ Emotional Function; MSQ-RP, MSQ Role Function-Preventive; MSQ-RR, MSQ Role Function-Restrictive; PI-MBS, patient-identified most bothersome symptom; QoL, (health-related) quality of life; Sens., sensitivity
Fig. 2
Fig. 2
Direct and mediated effect of eptinezumab on HRQoL HRQoL, health-related quality of life; MMDs, monthly migraine days; PI-MBS, patient-identified most bothersome symptom
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