Fremanezumab for Preventive Migraine Treatment in Patients With Major Depressive Disorder: Baseline Patient Characteristics in the Phase 4 UNITE Study

Abstract: Introduction: Major depressive disorder (MDD) is a common migraine comorbidity. Fremanezumab, a humanized monoclonal antibody selectively targeting calcitonin gene-related peptide, is approved for preventive treatment of episodic and chronic migraine (EM/CM) in adults. Objective: The ongoing UNITE study is assessing efficacy and safety of fremanezumab in adults with EM or CM and MDD; baseline characteristics are presented here. Methods: This 28-week study includes a 4-week baseline period; 12-week randomized, double-blind, placebo-controlled period (DBP); and 12-week open-label extension (OLE). In the DBP, patients are randomized to fremanezumab (225mg monthly) or placebo. For the OLE, all patients receive fremanezumab (675mg quarterly). Eligible patients had a Patient Health Questionnaire-9 (PHQ-9) score ≥10 validating the presence and severity of MDD. Primary endpoint is change in average monthly migraine days (MMD) from baseline to week 12. Results: 237 patients (mean±standard deviation [SD] age: 42.7±12.51 years; female, 88%; white, 96%) have enrolled. Of these, 19% are from the US, 61% from Europe, and 20% from the rest of the world. At randomization, 52% had CM and 48% had EM. At baseline, patients reported mean±SD 15.2±6.23 MMD; 17-item Hamilton Depression Rating Scale score, 16.2±6.40; Migraine-specific quality of life questionnaire version 2 restrictive, preventive, and emotional function scores, 38.2±15.07, 53.7±21.85, and 49.0±24.63, respectively; Clinical Global Impression-Severity rating, 3.6±1.14; Headache Impact Test score, 65.6±4.30; and PHQ-9 score, 15.8±3.85. Conclusion: 52% of patients had CM and patients generally reported moderately severe depression per PHQ-9 at baseline. Assessing fremanezumab efficacy in patients with migraine and MDD will help inform treatment decisions.Short Description: The ongoing UNITE study is assessing efficacy and safety of fremanezumab in adults with episodic or chronic migraine and major depressive disorder; baseline characteristics are presented here.Name of Sponsoring Organization(s): Teva Pharmaceuticals