Abstracts
3427225
(#55) Safety and Efficacy of Aripiprazole Lauroxil in an Outpatient Setting After Initiation During Hospitalization for an Acute Exacerbation of Schizophrenia
Abstract: Introduction: The period following discharge from an acute schizophrenia hospitalization carries a high risk of relapse, rehospitalization, suicide, and medication nonadherence. Treatment strategies must prioritize sustained symptom control beyond discharge. Aripiprazole lauroxil (AL) is a long-acting injectable antipsychotic that can be initiated during acute care, ensuring adequate coverage after discharge to bridge inpatient stabilization with outpatient maintenance.
Methods: This post-hoc analysis focused on the outpatient period of a 25-week phase 3b study evaluating the use of AL (with paliperidone palmitate as active control) started during a short hospitalization for acute schizophrenia. Adult patients who were enrolled as inpatients, randomized to AL (1064mg every-2-months), discharged after 2-3 weeks, and followed as outpatients (≤23 weeks) were included. Efficacy was evaluated using Positive and Negative Syndrome Scale (PANSS) scores, and safety was monitored based on adverse events (AEs), both from day of hospital discharge through the end of study.
Results: Of 99 patients randomized to AL, 84 (84.8%) remained in the study postdischarge; 56 (66.7%) completed outpatient treatment. After acute inpatient symptom improvement, the mean (SD) PANSS total score was 77.3 (14.2) at discharge; the additional least squares mean (SE) change was -5.3 (1.3) at 23 weeks postdischarge. The most common AE (≥5%) was weight increase (10.7%). Six patients (7.1%) discontinued because of AEs.
Conclusions: After inpatient initiation of AL every-2-months, schizophrenia symptom severity remained stable during outpatient care. AL's safety and tolerability profile supports its use for maintenance treatment following transition from inpatient care.
Short Description: This post hoc analysis of the ALPINE study evaluated 23-week outpatient efficacy, safety, and tolerability of aripiprazole lauroxil (AL), including the discharge-to-next-dose transition following inpatient initiation. Symptom control was maintained from discharge through outpatient week 23, with stable PANSS Total scores. Outpatient safety and tolerability were consistent with the known profile of AL, with no new safety signals among patients discharged fully initiated on AL, supporting continuity of care and sustained stability after hospital discharge.
Name of Sponsoring Organization(s): This study was sponsored by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.
Methods: This post-hoc analysis focused on the outpatient period of a 25-week phase 3b study evaluating the use of AL (with paliperidone palmitate as active control) started during a short hospitalization for acute schizophrenia. Adult patients who were enrolled as inpatients, randomized to AL (1064mg every-2-months), discharged after 2-3 weeks, and followed as outpatients (≤23 weeks) were included. Efficacy was evaluated using Positive and Negative Syndrome Scale (PANSS) scores, and safety was monitored based on adverse events (AEs), both from day of hospital discharge through the end of study.
Results: Of 99 patients randomized to AL, 84 (84.8%) remained in the study postdischarge; 56 (66.7%) completed outpatient treatment. After acute inpatient symptom improvement, the mean (SD) PANSS total score was 77.3 (14.2) at discharge; the additional least squares mean (SE) change was -5.3 (1.3) at 23 weeks postdischarge. The most common AE (≥5%) was weight increase (10.7%). Six patients (7.1%) discontinued because of AEs.
Conclusions: After inpatient initiation of AL every-2-months, schizophrenia symptom severity remained stable during outpatient care. AL's safety and tolerability profile supports its use for maintenance treatment following transition from inpatient care.
Short Description: This post hoc analysis of the ALPINE study evaluated 23-week outpatient efficacy, safety, and tolerability of aripiprazole lauroxil (AL), including the discharge-to-next-dose transition following inpatient initiation. Symptom control was maintained from discharge through outpatient week 23, with stable PANSS Total scores. Outpatient safety and tolerability were consistent with the known profile of AL, with no new safety signals among patients discharged fully initiated on AL, supporting continuity of care and sustained stability after hospital discharge.
Name of Sponsoring Organization(s): This study was sponsored by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.
