Switching Patients with Stable Schizophrenia from Oral Antipsychotics to Monthly Aripiprazole Lauroxil: Post hoc Analysis of a Long-term Outpatient Study

January 10, 2017

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Background: Aripiprazole lauroxil (AL; ARISTADA®; Alkermes, Inc.) is an extended-release injectable antipsychotic approved for the treatment of schizophrenia. We report on the safety and effectiveness of switching patients from current oral antipsychotics to 1 year of monthly AL therapy.

Methods: Data were from a 1-year open-label safety study of AL (N=478). This post hoc analysis was on the subgroup (n=190) initiating AL as stable outpatients on oral antipsychotic therapy. Subjects were crossed over from their oral agent to monthly 882 mg AL along with 3 weeks 15 mg/day oral aripiprazole during the transition. Post hoc comparison groups were based on the prior antipsychotic: aripiprazole (n=56); risperidone/paliperidone (n=52); conventional (n=37); olanzapine (n=19), and quetiapine (n=26). Initial (1-month) akathisia adverse events (AEs), as well as prolactin change (by gender), study retention, and symptom trajectory (measured by PANSS total score) over the 1-year period were analyzed.

Results: Initial akathisia AE rates were comparable for most subgroups (3.6%-5.3%) except for the conventional subgroup, which had no early akathisia AEs. Female subjects switching from risperidone/paliperidone had the greatest prolactin decrease. Study retention ranged from 52.6% to 73.2% (p value not significant). The aripiprazole group showed a consistent and greater degree of symptom improvement (p<.002).

Conclusions: There was no relation between oral antipsychotic before the switch and likelihood of akathisia. Retention rates over the year were relatively high, with no evidence of later waning of effectiveness. The aripiprazole group experienced a more consistent trajectory of symptom improvement. The post hoc nature is a study limitation.

Peter Weiden, MD
Robert Risinger, MD
Arielle Stanford, MD
Yangchun Du, PhD
Hassan Jamal, MSc
Chih-Chin Liu, PhD
Sponsoring Organization: 
Alkermes, Inc
Presented By: 
Peter Weiden, MD, Sr. Medical Director, Medical Affairs, Alkermes, Inc., Waltham, MA
Psychotic Disorders