Abstract Details

Title Patient-identified most bothersome symptom as a driver of health-related quality of life experienced by patients with migraine

Topic Headache

Presentation(s) P8 - Poster Session 8 (11:45 AM-12:45 PM)

Poster/Presentation
Number 2-010

Objective To identify efficacy measures mediating eptinezumab’s effect on health-related quality of life (HRQoL) improvements in patients with migraine.

Background DELIVER (NCT04418765) was a randomized, double-blind, placebo-controlled trial exploring eptinezumab’s safety and efficacy in patients with migraine and 2-4 prior preventive migraine treatment failures. At Weeks 12 and 24, eptinezumab resulted in significantly larger Migraine Specific Quality of Life Questionnaire (MSQ, v2.1) domain score improvements versus placebo.

Design/Methods

A latent variable (HRQoL improvement) was constructed to summarize improvement in patient-reported MSQ Emotional-Function, Role-Preventive, and Role-Restrictive domain scores. After determining goodness of fit, two models were used to identify potential effect mediators from treatment (eptinezumab 100mg and 300mg pooled vs. placebo) on HRQoL. In Model 1, changes in migraine frequency (monthly migraine days [MMDs]), proportion of severe migraine attacks, and proportion of migraine attacks with cardinal symptoms (nausea, light sensitivity, and pulsating headache) were included as mediators. In Model 2, only changes in MMDs and patient-identified most bothersome symptom (PI-MBS) were included as mediators. Each model included treatment as the exogeneous variable and the HRQoL latent construct as the dependent variable. Analyses were conducted on DELIVER data from all patients in the double-blind period (Weeks 1?24), using the LAVAAN package for R.

Results Reductions in MMDs and proportion of migraine attacks with cardinal symptoms (including severity) accounted for 35% and 25% of HRQoL improvement, respectively, with 40% of the observed improvement with eptinezumab unexplained by mediators (“direct treatment effect”) (Model 1). Substantial improvement in HRQoL (86%) with eptinezumab is due to MMD reduction and change in PI-MBS, with change in PI-MBS contributing more than MMD reduction (69% vs 18%) (Model 2).

Conclusions

The burden placed on patients’ HRQoL is driven by efficacy measures beyond migraine frequency. Physicians should discuss improvements in patients’ most bothersome symptom associated with migraine, as this may impact HRQoL.

Authors/Disclosures
Peter Goadsby, MD, PhD, FRS (King Abdullah Univeristy of Science and Technology) PRESENTER	Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health LLC. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Kallyope. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Seaport Therapeutics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dr Reddy's. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Orion Pharma. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Massachusetts Medical Society. The institution of Dr. Goadsby has received research support from NIHR. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has a non-compensated relationship as a Trustee with Migraine Trust that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Trustee with Organisation for Understanding Cluster Headache (UK) that is relevant to AAN interests or activities.
	No disclosure on file
Susanne Awad (H. Lundbeck A/S)	Susanne Awad has received personal compensation for serving as an employee of Lundbeck.
Stephane Regnier, PhD (Lundbeck)	Mr. Regnier has received personal compensation for serving as an employee of Lundbeck. Mr. Regnier has received personal compensation for serving as an employee of Novartis. Mr. Regnier has stock in Novartis.
	No disclosure on file
Steven Kymes	Steven Kymes has received personal compensation for serving as an employee of Lundbeck. Steven Kymes has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for American Journal of Ophthalmology. Steven Kymes has received research support from Emmes Corporation.
Xin Ying Lee (Lundbeck A/S)	No disclosure on file

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