Safety and Tolerability of Brexpiprazole for the Treatment of Borderline Personality Disorder: a 12-Week, Flexible-Dose, Open-Label Extension Study

Abstract: Background: Atypical antipsychotics may be efficacious in the treatment of borderline personality disorder (BPD). This study assessed the safety, tolerability and efficacy of brexpiprazole in patients with BPD (NCT04186403). Methods: Patients with BPD who had completed a previous randomized, double-blind, placebo-controlled parent study (NCT04100096) were enrolled into the present open-label extension study, for treatment with brexpiprazole 2–3 mg/day for up to 12 weeks. The primary endpoint was the frequency and severity of adverse events (AEs). Efficacy was assessed as an exploratory endpoint by changes in Zanarini Rating Scale for BPD (ZAN-BPD) Total score and Clinical Global Impression – Severity (CGI-S) score. Results: Open-label brexpiprazole was administered to 199 patients, 88 of whom had previously received brexpiprazole in the parent study, and 111 had previously received placebo. Overall, 43.2% of patients reported treatment-emergent AEs (TEAEs), the most common of which (≥5%) were insomnia (5.5%) and akathisia (5.0%). The incidence of TEAEs was lower in the subgroup previously treated with brexpiprazole (34.1%) compared with the subgroup previously treated with placebo (50.5%). In exploratory efficacy analyses, open-label brexpiprazole was associated with further reductions from baseline to Week 12 in ZAN-BPD Total score and CGI-S score. Improvements from baseline were numerically greater in the prior placebo subgroup than in the prior brexpiprazole subgroup. Conclusion: Open-label treatment with brexpiprazole 2–3 mg/day for 12 weeks was generally well tolerated in patients with BPD, regardless of previous exposure to brexpiprazole. Open-label treatment with brexpiprazole was associated with continued improvement in symptoms of BPD.Short Description: This open-label extension study assessed the safety, tolerability and efficacy of brexpiprazole 2–3 mg/day for up to 12 weeks in 199 patients with borderline personality disorder (BPD; NCT04186403). Treatment-emergent adverse events (TEAEs) occurred in 43.2% of patients, most commonly insomnia (5.5%) and akathisia (5.0%). The incidence of TEAEs was lower in patients previously treated with brexpiprazole (34.1%) than with placebo (50.5%). Open-label brexpiprazole was associated with continued improvement in symptoms of BPD.Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA, and H. Lundbeck A/S, Valby, Denmark