Switching Patients With Schizophrenia From Paliperidone Palmitate to Aripiprazole Lauroxil: A 6-month, Prospective Open-label Study

December 21, 2017

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Background: Despite the growing number of long-acting antipsychotic formulations available for the treatment of schizophrenia, there is a lack of information on switching between these options in clinical practice. The goal of this study was to assess efficacy, safety, and dosing strategies when switching from monthly paliperidone palmitate (PP) to aripiprazole lauroxil (AL) (ClinicalTrials.gov: NCT02634320).

Methods: This was a prospective, 6-month, open-label study of patients with schizophrenia stabilized on PP who continued to experience symptoms or treatment intolerance that might be addressed by change in antipsychotic regimen. After assessing the reason(s) for switching, patients were started on a flexible-dose AL regimen (441mg, 662mg or 882mg every 4 weeks or 882mg every 6 weeks; specific dose chosen as per clinical judgment) and followed for 6 months. Outcomes included symptom changes from baseline to study end (using the Brief Psychiatric Rating Scale [BPRS] and Clinical Global Impression-Severity [CGI-S] scale) and adverse events (AEs).

Results: In total, 51 patients participated in the study with 35 (69%) completing 6 months. The primary reason for switching to AL was insufficient control of positive symptoms (67%). The mean BPRS total score decreased from 37.6 to 32.7 (p=0.002), and the CGI-S score from 3.9 to 3.4 (p<0.001), between baseline and the 6-month endpoint. Treatment-emergent AEs (TEAEs) were reported in 41% of patients, with the most common being psychotic disorders (8%).

Conclusions: Switching from monthly PP to AL was associated with reductions in schizophrenia symptoms; AEs were generally consistent with the known safety profile of AL.

Authors: 
Steven G Potkin, MD; Yangchun Du, PhD; Amy Claxton, PhD; Elizabeth Amoroso, BA; Peter J Weiden, MD
Sponsoring Organization: 
Alkermes, Inc.
Year: 
2017
Tracks: 
Schizophrenia