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Patient-identified most bothersome symptom in preventive migraine treatment with eptinezumab: A novel patient-centered outcome

Headache: The Journal of Head and Face Pain May 28, 2021

Lipton RB, Dodick DW, Ailani J, et al. - This study was carried out to present the methodology and implications of the patient-identified most bothersome symptom (PI-MBS) measure used in phase 3, multicenter, randomized, double-blind, placebo-controlled, and parallel-group PROMISE-2 trial and to explore the contribution of this measure to the evaluation of the preventive migraine benefits of treatment. Individuals with chronic migraine (CM) were assigned randomly to receive intravenous (IV) eptinezumab 100 mg, eptinezumab 300 mg, or placebo, administered on day 0 and every 12 weeks. Researchers enrolled a total of 1,072 patients who received treatment (eptinezumab 100 mg, n = 356; eptinezumab 300 mg, n = 350; placebo, n = 366). A broad range of PI-MBS was reported at baseline among patients with CM in the PROMISE-2 study. Compared with placebo recipients, patients treated with eptinezumab reported greater improvement in their PI-MBS severity, and this improvement correlated strongly with PGIC findings. The outcomes imply that PI-MBS is a promising and novel outcome measure for preventive trials of CM and thus may provide a unique patient-centered approach for distinguishing and assessing the burden of migraine symptoms that matter most to each patient, as well as the benefits of treatment.

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