Clinical Psychopharmacology and Neuroscience Papers in Press available online.

 
Asian subgroup analysis of the REMISSIO study: a long-term efficacy and safety study of paliperidone palmitate 3-month formulation in patients with stable schizophrenia in a naturalistic clinical setting
Young-Chul Chung 1, Yen Kuang Yang 2, Ahmad Hatim Sulaiman 3, Paul Bergmans 4, Wilson Tan 5,*
1Department of Psychiatry, Jeonbuk National University Medical School, Jeonju, Korea, 2Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan, 3Department of Psychological Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia, 4Biostatistics, Janssen-Cilag, Breda, The Netherlands, 5Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore, Singapore
Abstract
Objective:
To evaluate the long-term efficacy and safety of three-monthly paliperidone palmitate (PP3M) in Asian patients with stable schizophrenia in a naturalistic setting.
Methods:
Asian patients recruited between May 2016 and March 2018 from the prospective, single-arm, non-randomized, open-label, multi-national REMISSIO study were analyzed. Patients received PP3M over 12 months following ≥4 months of treatment with one-monthly paliperidone palmitate. The primary efficacy endpoint was the proportion of patients who achieved symptomatic remission. Other endpoints were changes in Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance (PSP) total scores, hospitalization rates, and safety.
Results:
A total of 71 patients (23.3%) were Asian (South Korea: 33; Malaysia: 21; Taiwan: 17); 95.8% of patients completed the study. At LOCF, 71% of Asian patients achieved symptomatic remission compared to the overall population (n=172/303, 56.8%). Improvements in mean (SD) PANSS and PSP total scores from baseline to LOCF in Asian patients and overall population were clinically significant. A lower proportion of Asian patients had ≥1 psychiatric hospitalization after PP3M treatment (n=1/70, 1.4%) than during the 12 months before (n=12/70, 17.1%); compared with patients in the overall population after (n=8/303, 2.6%) and before PP3M treatment (n=37/303, 12.2%). The overall incidence of treatment-emergent adverse events across Asian patients was 62.9% compared to 53.1% in the overall population. Safety findings were consistent with the known safety profile of PP3M.
Conclusion:
Our findings confirm existing evidence on the efficacy and tolerability of PP3M in Asian patients with stable schizophrenia over 12 months of treatment.
Accepted Manuscript [Submitted on 2020-12-09, Accepted on 2021-04-25]