Efficacy of Fremanezumab Quarterly and Monthly Dosing Regimens in Patients With Migraine and Psychiatric Comorbidities

Abstract: Introduction: Migraine with psychiatric comorbidities has been associated with increased disability, pain, and reduced quality-of-life. Fremanezumab, a humanized monoclonal antibody selectively targeting calcitonin gene-related peptide, is approved for migraine preventive treatment in adults. Objective: To evaluate efficacy of quarterly fremanezumab (QTY-F) or monthly fremanezumab (MLY-F) versus placebo (PBO) in patients with migraine and ≥1 selected psychiatric comorbidity. Methods: Data were pooled from patients randomized 1:1:1 to QTY-F, MLY-F or PBO during the 3-month double-blind period (DBP) of the HALO CM, HALO EM, and FOCUS studies who then enrolled in longer-term studies (LTS; 12-month HALO LTS or 3-month FOCUS open-label extension [OLE]). Analyses were conducted using 6-month data for patients rolling over from HALO CM and EM to HALO LTS or from FOCUS DBP to FOCUS OLE. Changes from baseline in monthly migraine days (MMD) and proportion of patients with ≥50% reduction in MMD (≥50% responder rate) were evaluated in patients with ≥1 selected psychiatric comorbidity. Results: Of 2,697 patients, 616(23%) with migraine and ≥1 psychiatric comorbidity were identified (depression, 412[67%]; anxiety, 285[46%]). During 3-months, greater mean reductions in MMD were reported with QTY-F (−4.3) or MLY-F (−4.9) than with PBO (−2.8) and were sustained through 6-months (QTY-F, –5.5; MTY-F, –6.3; PBO, –5.7). The ≥50% responder rate was higher with fremanezumab than PBO during 3-months (QTY-F, 32%; MTY-F, 36%; PBO, 19%) and was maintained at 6-months (QTY-F, 42%; MTY-F, 50%; PBO, 47%). Conclusion: Fremanezumab reduced MMD and increased the ≥50% responder rate in patients with migraine and ≥1 selected psychiatric comorbidity.Short Description: Migraine with psychiatric comorbidities has been associated with increased disability, pain, and reduced quality-of-life. Fremanezumab, a humanized monoclonal antibody selectively targeting calcitonin gene-related peptide, is approved for migraine preventive treatment in adults. This study evaluated efficacy of quarterly or monthly fremanezumab versus placebo in patients with migraine and ≥1 selected psychiatric comorbidity.Name of Sponsoring Organization(s): Teva Pharmaceuticals