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Poster
1572365
Impact of Fremanezumab Treatment on Disability Outcomes in Patients With Migraine and Major Depressive Disorder: Results of the UNITE Study
Psych Congress 2023
This study was funded by Teva Pharmaceuticals.
Background and Aims:
Major depressive disorder (MDD) is a prevalent comorbidity associated with migraine. Together, both disorders can negatively impact quality of life (QoL). UNITE examined the impact of fremanezumab, a monoclonal antibody that selectively targets the calcitonin gene-related peptide (CGRP) pathway, on disability outcomes in adults with migraine and MDD.
Methods:
UNITE (NCT04041284) was a 12-week, randomized, double-blind, parallel group study. Patients (n = 353; 88% female), diagnosed with migraine and MDD with active moderate-to-severe depression, were randomized (1:1) to monthly fremanezumab (225 mg) or placebo. Patients in the 12-week open-label extension (OLE) received quarterly fremanezumab (675 mg). Secondary endpoints included change from baseline in disability scores, assessed using the 6-item Headache Impact Test (HIT-6; range