A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea

Abstract

This study was designed to investigate long-term clinical outcomes of risperidone long-acting injectable (RLAI) in patients with schizophrenia or schizoaffective disorder. An open-label, 48-week, prospective study of RLAI treatment was carried out at 63 centers in South Korea. Initial and maintenance dosage of RLAI were adjusted according to clinical judgment. Efficacy was measured by the remission rate, continuation rate, and changes in the clinical measurements such as eight items of the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression - Severity, and the Schizophrenia Quality of Life Scale. In terms of the safety, Simpson-Angus rating Scale, adverse events (AEs), and BMI were investigated. Of the 522 patients who were enrolled, 472 patients who had been assessed on the eight items of PANSS at baseline and at least once during RLAI treatment were included in the intention-to-treat (ITT) population. The per-protocol (PP) population included 184 patients (39.0%), who completed all assessments during 48 weeks of the follow-up period. Total scores of eight items of PANSS, Clinical Global Impression - Severity, and Schizophrenia Quality of Life Scale were reduced significantly from baseline to endpoint in both ITT and PP populations. The mean dose (SD) of RLAI was 33.2 (7.6) mg. In the PP population, the number of patients who scored 1-3 on eight items of PANSS were 47 (25.5%) at baseline and 144 (78.3%) at 48 weeks. According to the remission defining as scores 1-3 on eight items of PANSS sustaining of at least 6 months' duration by Andreasen, the numbers of patients who achieved remission were 45 (24.5%) at 24 weeks and 120 (65.2%) at 48 weeks. A significant decrease in the mean score of Simpson-Angus rating Scale and a significant increase in BMI over time in last observation carried forward were observed, and patients who fulfilled the remission criteria during the study showed more weight gain than those who did not. During the study period, a total of 645 AEs were noted in 233 patients (49.3%) who were included in the ITT population. Sixty-nine serious AEs in 51 patients were reported, but all of them were not directly attributable to administration of RLAI. This prospective, open-label study showed improvements in symptom and AEs and a significant increase in BMI during 48 weeks of biweekly RLAI treatment. The rate of study completion was 39.0% and the remission rate among those who completed the study was 65.2%. None of the serious AEs were directly related to the administration of RLAI.

Second-generation long-acting injectable antipsychotics in schizophrenia: patient functioning and quality of life

“…These results are confirmed by other studies conducted in France, 79 Italy, 80 Japan, 81 and Korea, 82 with longer follow-up (52 weeks), 80 associated with psychosocial intervention. 81 …”

“… 81 An open-label, 48-week, prospective study on 522 patients with schizophrenia or schizoaffective disorder from 63 centers in South Korea highlighted clinical improvements in symptom severity (PANSS, CGI-S) and QOL (Schizophrenia Quality of Life scale). 82 …”

Discontinuation rates during long‐term, second‐generation antipsychotic long‐acting injection treatment: A systematic review

“…In the study by Lee et al . in patients with SCZ spectrum disorders treated with RIS ‐ LAI, more than 60% of patients dropped out of the study.…”

“…In the study by Lee et al 92 in patients with SCZ spectrum disorders treated with RIS-LAI, more than 60% of patients dropped out of the study. The most frequent cause of discontinuation was loss to follow-up.…”

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

“…This result is relatively high for a long-term study on schizophrenia. By comparison, study completion rates in other PP3M studies were 83−84% [ 6 , 25 ] and that in RLAI studies ranged between 39% and 71% [ 28 - 31 ]. These are important findings as treatment discontinuation rates have been reported to be high amongst patients with schizophrenia.…”