Abstracts
3427224
(#54) Inpatient Initiation of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil for the Treatment of Acute Exacerbations of Schizophrenia
Abstract: Introduction: Treatment of schizophrenia exacerbations requires balancing acute symptom control with the longer-term goal of optimizing continued outpatient treatment. Long-acting injectable (LAI) formulations can address both goals when clinicians have an understanding of, and confidence in, LAI safety and efficacy. This report focuses on clinical outcomes for aripiprazole lauroxil (AL) initiated during hospitalization for acute schizophrenia.
Methods: This post-hoc analysis assessed the 2-week inpatient period of the 25-week ALPINE study, which evaluated AL (active control: paliperidone palmitate) for treatment of acutely exacerbated schizophrenia. Patients enrolled as inpatients and randomized to AL1064mg every-2-months, started after a 1-day initiation regimen (AL NanoCrystal Dispersion plus one 30mg oral aripiprazole dose), were included. Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS). Early treatment response was defined as ≥20% reduction in PANSS total score from baseline (predose) to discharge. Safety was assessed based on adverse events (AEs).
Results: Ninety-nine patients were randomized to AL; 90 (90.9%) patients completed the 2-week treatment period. The mean (SD) baseline PANSS total score was 94.1 (9.0). At day 15, the least squares mean (SE) change from baseline in PANSS total score was -15.4 (1.3) for AL-treated patients; 55.2% met early treatment response criteria. Common AEs (≥5%) were injection site pain (15.2%), akathisia (9.1%), and headache (5.1%).
Conclusions: Initiation of AL can be completed with a 1-day regimen in hospitalized patients, providing symptom reduction with confidence of having drug on board to support the transition to outpatient care.
Short Description: This post hoc analysis of the ALPINE study evaluated early response to aripiprazole lauroxil (AL), initiated with the 1-day regimen, during a 2-week inpatient hospitalization for acute schizophrenia. Over 2 weeks, clinically meaningful improvements were observed in PANSS Total and Marder Factor scores, with safety and tolerability consistent with the known AL profile. Collectively, these data support AL as a well-tolerated treatment option that provides early symptom reduction and facilitates transition to outpatient care.
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 assessed the 2-week inpatient period of the 25-week ALPINE study, which evaluated AL (active control: paliperidone palmitate) for treatment of acutely exacerbated schizophrenia. Patients enrolled as inpatients and randomized to AL1064mg every-2-months, started after a 1-day initiation regimen (AL NanoCrystal Dispersion plus one 30mg oral aripiprazole dose), were included. Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS). Early treatment response was defined as ≥20% reduction in PANSS total score from baseline (predose) to discharge. Safety was assessed based on adverse events (AEs).
Results: Ninety-nine patients were randomized to AL; 90 (90.9%) patients completed the 2-week treatment period. The mean (SD) baseline PANSS total score was 94.1 (9.0). At day 15, the least squares mean (SE) change from baseline in PANSS total score was -15.4 (1.3) for AL-treated patients; 55.2% met early treatment response criteria. Common AEs (≥5%) were injection site pain (15.2%), akathisia (9.1%), and headache (5.1%).
Conclusions: Initiation of AL can be completed with a 1-day regimen in hospitalized patients, providing symptom reduction with confidence of having drug on board to support the transition to outpatient care.
Short Description: This post hoc analysis of the ALPINE study evaluated early response to aripiprazole lauroxil (AL), initiated with the 1-day regimen, during a 2-week inpatient hospitalization for acute schizophrenia. Over 2 weeks, clinically meaningful improvements were observed in PANSS Total and Marder Factor scores, with safety and tolerability consistent with the known AL profile. Collectively, these data support AL as a well-tolerated treatment option that provides early symptom reduction and facilitates transition to outpatient care.
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.
