Long-Term Efficacy and Safety of Brexpiprazole in Elderly Japanese Patients with Schizophrenia: A Subgroup Analysis of an Open-Label Study.

This study was performed to assess the long-term efficacy, safety, and tolerability of brexpiprazole in elderly Japanese patients with schizophrenia. This is a post hoc analysis of a previous open-label study conducted over 56 weeks which consisted of two consecutive phases: a 4-week switching period and a 52-week open-label period. Mean change in the Positive and Negative Syndrome Scale (PANSS) total score, response rates, number and incidence of treatment-emergent adverse events (TEAEs), and other safety parameters were analyzed using descriptive statistics based on age group (elderly, ≥65 and non-elderly, <65). This post hoc analysis included 208 de novo patients of which 33 were elderly. The continuation rate in elderly patients was 54.5%, and the mean daily dose and treatment duration of brexpiprazole in elderly patients at week 56 were similar to those of non-elderly patients. The mean change in the PANSS total score from the baseline to week 56 was -13.8 in elderly patients and this improvement was maintained throughout the open-label phase. This outcome was comparable to that of the non-elderly patients (-9.0). The incidence rate of TEAEs was 97.0% in elderly patients and 82.3% in non-elderly patients. Most of the TEAEs were either mild (75.8%) or moderate (18.2%) in severity in the elderly patients and the incidence of TEAEs leading to discontinuation was lower in elderly (9.1%) than in non-elderly patients (13.1%). The most commonly observed adverse events in elderly patients were nasopharyngitis (30.3%) and worsening of schizophrenia (27.3%). The safety profiles in both groups were similar. Brexpiprazole was shown to be safe and effective in the treatment of elderly Japanese patients with schizophrenia.

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© 2020 Inada et al.

Déclaration de conflit d'intérêts

This study was funded by Otsuka Pharmaceutical Co., Ltd. Dr. Inada has received speaker’s honoraria from Eisai, Eli Lilly Japan, Janssen, Meiji Seika Pharma, Mitsubishi Tanabe Pharma, Mochida, MSD, Novartis, Otsuka pharmaceutical Co., Ltd., Shionogi, Sumitomo Dainippon Pharma, and Yoshitomiyakuhin, and research grants from Japan Agency for Medical Research and Development (AMED), Ministry of Health, Labour and Welfare, Mitsubishi Tanabe Pharma, MSD, and National Center of Neurology and Psychiatry (NCNP). Dr. Ishigooka has received speaker’s honoraria from Astellas, Alfresa, Novartis, Otsuka pharmaceutical Co., Ltd, Sumitomo Dainippon Pharma, Eisai, Eli Lilly Japan, and Takeda pharmaceutical Co., Ltd. Ms. Yamada, Mr. Akiyoshi, Mr. Kojima and Mr. Iwashita are employees of Otsuka Pharmaceutical Co., Ltd. The authors report no other conflicts of interest in this work.