Safety and effectiveness of oral medium to high dose blonanserin in patients with schizophrenia: subgroup analysis from a prospective, multicenter, post-marketing surveillance study in mainland China

Yuan Yang; Hongmin Ge; Xijin Wang; Xuejun Liu; Keqing Li; Gang Wang; Xiaodong Yang; Huaili Deng; Meijuan Sun; Ruiling Zhang; Jindong Chen; Duanfang Cai; Hong Sang; Xianglai Liu; Guilai Zhan; Guijun Zhao; Haiyun Li; Zhiyuan Xun

doi:10.1186/s12991-023-00467-w

Safety and effectiveness of oral medium to high dose blonanserin in patients with schizophrenia: subgroup analysis from a prospective, multicenter, post-marketing surveillance study in mainland China

Ann Gen Psychiatry. 2023 Oct 6;22(1):37. doi: 10.1186/s12991-023-00467-w.

Authors

Yuan Yang^#¹, Hongmin Ge^#¹, Xijin Wang², Xuejun Liu³, Keqing Li⁴, Gang Wang^{5

6}, Xiaodong Yang⁷, Huaili Deng⁸, Meijuan Sun⁹, Ruiling Zhang¹⁰, Jindong Chen¹¹, Duanfang Cai¹², Hong Sang¹³, Xianglai Liu¹⁴, Guilai Zhan¹⁵, Guijun Zhao¹⁶, Haiyun Li¹⁷, Zhiyuan Xun¹⁸

Affiliations

¹ Department of Psychiatry, Tianjin Anding Hospital, Hexi District, Tianjin, 300222, China.
² Department of Psychiatry, The First Psychiatric Hospital of Harbin, Harbin, Heilongjiang, China.
³ Department of Psychiatry, Brain Hospital of Hunan Province, Changsha, Hunan, China.
⁴ Department of Psychiatry, Hebei Provincial Mental Health Center, Baoding, Hebei, China.
⁵ The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.
⁶ Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.
⁷ Department of Psychiatry, Shandong Mental Health Center, Jinan, Shandong, China.
⁸ Department of Psychology, Psychiatric Hospital of Taiyuan City, Taiyuan, Shanxi, China.
⁹ Department of Pharmacy, Daqing Third Hospital, Daqing, Heilongjiang, China.
¹⁰ Department of Psychiatry, Henan Mental Hospital, Xinxiang, Henan, China.
¹¹ Department of Psychiatry, and National Clinical Research Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
¹² Department of Psychiatry, The Fifth People's Hospital of Zigong, Zigong, Sichuan, China.
¹³ Mental Health Center, Changchun Sixth Hospital, Changchun, Jilin, China.
¹⁴ Institute of Mental Health, Hainan Provincial Anning Hospital, Haikou, Hainan, China.
¹⁵ Department of Psychiatry, Xuhui Mental Health Center, Shanghai, China.
¹⁶ Department of Psychiatry, Guangyuan Mental Health Center, Guangyuan, Sichuan, China.
¹⁷ Medical Affairs, Sumitomo Pharma (Suzhou) Co., Ltd. Shanghai, Shanghai, China.
¹⁸ Department of Psychiatry, Tianjin Anding Hospital, Hexi District, Tianjin, 300222, China. tjad002@163.com.

^# Contributed equally.

Abstract

Background: Blonanserin (BNS) had been undergoing post-market surveillance (PMS) since September 2018. Using the surveillance data, we did this analysis to assess the safety and effectiveness of different doses of BNS to explore a sufficient dose range of BNS in Chinese patients with schizophrenia (SZ).

Methods: A 12-week, prospective, observational, single-arm, multicenter, open-label PMS was conducted. In this analysis, we divided the patients from PMS into low, medium to high, and high dose groups based on the dose of BNS they received, with medium to high dose group being the focus. The Brief Psychiatric Rating Scale (BPRS) scores at week 2 or 4, 6 or 8, and 12 were calculated to evaluate the effectiveness of BNS in improving psychiatric symptoms. The safety of BNS was reported as the incidence of adverse drug reactions.

Results: 364 patients were included in the medium to high dose group, of which 321 completed the surveillance, with a dropout rate of 11.8%. The mean daily dose was 15.1 ± 1.92 mg. The BPRS total score was 50.1 ± 11.95 at baseline and decreased to 26.6 ± 7.43 at 12 weeks (P < 0.001). When compared with other groups, the median to high dose group achieved significantly more reduction in BPRS score at week 12 (P = 0.004 versus low dose and P = 0.033 versus higher dose). Extrapyramidal symptoms [EPS (46.4%)] were the most common adverse reactions in the medium to high group. The average weight gain during the surveillance was 0.5 ± 2.56 kg and prolactin elevation occurred in 2.2% patients. Most adverse reactions were mild.

Conclusions: BNS at medium to high doses (mean 15.1 mg/d) significantly improved symptoms of SZ and was well-tolerated. Most ADRs were mild, and the likelihood of causing metabolic side effects and prolactin elevations was low. Medium to high dose of BNS is a more potent treatment choice for SZ.

Trial registration number: ChiCTR2100048734. Date of registration: 2021/07/15 (retrospectively registered).

Keywords: Blonanserin; Effectiveness; Medium to high doses; Safety; Schizophrenia.