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Psych Congress  

Long-Term Outcomes With Aripiprazole Lauroxil for the Treatment of Schizophrenia: A 2-Year, Phase 3, Multicenter Extension Study

Authors  
Amy Claxton, PhD – Alkermes, Inc.; Yangchun Du, PhD – Alkermes, Inc.; John Lauriello, MD – University of Missouri-Columbia
Sponsor  
Alkermes, Inc.

Background: This post hoc analysis evaluated the trajectory of clinical symptoms and illness severity of outpatients with schizophrenia receiving ongoing long-acting injectable aripiprazole lauroxil (AL) for up to 2 years.

Methods: The long-term safety and durability of therapeutic effect of AL (441 or 882 mg every 4 weeks) for treatment of schizophrenia was shown in a 52-week safety study. Patients who completed this study enrolled in a follow-up long-term study for up to another 128 weeks. Data from the two long-term studies were combined for a post-hoc analysis of symptom trajectory over a total of 112 weeks (spanning both studies), using the Positive and Negative Syndrome Scale total (PANSST) and Clinical Global Impression-Severity (CGI-S) assessments. Safety was also evaluated.

Results: Overall, 432 of 478 patients entering the initial 52-week study were included in the post hoc analysis, and 49% (N=211/432) completed the full 112 weeks of follow-up. Over this period, PANSST and CGI-S scores improved significantly from baseline, with changes (least squares mean ± standard error) in PANSST scores of −5.46 ± 0.92 (P<0.0001) and −5.00 ± 0.53 (P<0.0001) for the 441 and 882mg doses, respectively; and changes in CGI-S scores of −0.32 ± 0.07 (P<0.0001) and −0.28 ± 0.04 (P<0.0001) for the 441 and 882 mg doses, respectively. AL was generally well tolerated over the 2-year follow-up, with a safety profile consistent with the initial 52-week study.

Conclusion: This post hoc analysis demonstrated the safety and continued therapeutic efficacy of AL in patients with schizophrenia over a 2-year follow-up.

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