Evaluating the clinical utility of the patient‐identified most bothersome symptom measure from PROMISE‐2 for research in migraine prevention

Abstract

Objective: To assess the utility of the novel patient-identified (PI) most bothersome symptom (MBS) measure from PROMISE-2, a phase 3 trial of eptinezumab for the preventive treatment of chronic migraine. Background: Relief of bothersome migraine symptoms can influence satisfaction with treatment and therapeutic persistence. Understanding the impact of preventive treatment on a PI-MBS could improve clinical decision-making. Methods: In PROMISE-2, patients with chronic migraine received eptinezumab 100, 300 mg, or placebo administered intravenously every 12 weeks for up to 2 doses (n = 1072). PI-MBS was an exploratory outcome requiring each patient to self-report their MBS in response to an open-ended question. At baseline and week 12, patients rated overall improvement in PI-MBS. The relationships among PI-MBS at week 12 and change in monthly migraine days (MMDs) from baseline to month 3 (weeks 9-12), Patient Global Impression of Change at week 12, and changes from baseline to week 12 in the 6-item Headache Impact Test total, EuroQol 5-dimensions 5-levels visual analog scale, and 36-item Short-Form Health Survey component scores were assessed. Results: Treatment groups had similar baseline characteristics and reported a total of 23 unique PI-MBS, most commonly light sensitivity (200/1072, 18.7%), nausea/vomiting (162/1072, 15.1%), and pain with activity (147/1072, 13.7%). Improvements in PI-MBS at week 12 correlated with changes in MMDs (ρ = −0.49; p < 0.0001) and other patient-reported outcomes. Controlling for changes in MMDs, PI-MBS improvement predicted other patient-reported outcomes in expected directions. The magnitude of

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

“…For the PI-MBS [30,31], patients verbally described the most bothersome symptom that they associated with their migraine at the baseline visit. The investigator then categorized the verbal response into predefined categories including nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity and mood changes, with an "other" category available with free-text description at the investigator's discretion.…”

A real‐world prospective observational study of eptinezumab in Asian patients with migraine

“…39,40 PI-MBS improvement was found to be significantly correlated with improvement in other patient-reported outcomes. 40 Patients were asked to verbally identify their most bothersome symptom associated with headache (nausea, vomiting, photophobia, phonophobia, pain with activity, mental cloudiness, fatigue, mood changes, or other) at the baseline visit. At Months 3 and 6, patients were asked to rate the change in their MBS since the last visit on a 7-point scale ("very much improved" to "very much worse").…”

Headache/migraine-related stigma, quality of life, disability, and most bothersome symptom in adults with current versus previous high-frequency headache/migraine and medication overuse: results of the Migraine Report Card survey

“…Previous literature has shown that photophobia is the most commonly endorsed symptom, especially when patients are asked to select from the three standard MBS options [ 23 ]. However, in a previous study in which patients with chronic migraine self-identified their MBS, patients reported 23 unique symptoms, of which the most common were light sensitivity, nausea/vomiting, and pain with activity [ 22 ]. The MBS may be different for individual patients and may change over time.…”

“…Clinical trials of acute migraine treatment evaluate an MBS using an investigator-led questionnaire about the incidence of 3 common symptoms. In more recent studies, a patient-identified MBS measurement has been used [ 22 , 23 ]. In the Migraine Report Card survey, we offered respondents an expanded list of symptoms from which to identify the most bothersome, including headache pain, photophobia, phonophobia, nausea, and cognitive impacts, among others.…”