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Psych Congress  

Effect of Aripiprazole Lauroxil on Personal and Social Functioning and Health-Related Quality of Life Among Patients with Schizophrenia

Authors  
Peter Weiden, MD
Srdjan Sankovic, MD
Robert Stankovic, MD
Yangchun Du, PhD
Jacqueline Zummo, MPH, MBA
Anjana Bose, PhD
Bernard L. Silverman, MD
Elliot Elrich, MD
Sponsor  
Alkermes, Inc.

Background: Efficacy and safety of aripiprazole lauroxil long-acting injectable (AL) 441 mg and 882 mg were demonstrated in a placebo-controlled 12-week study in patients with acute schizophrenia. Post-hoc analyses were conducted on effects of AL on personal and social functioning and health-related quality-of-life. Methods: Subjects (N=622) were randomized and received AL 441 mg, 882 mg, or placebo, once-monthly. Assessments included change from baseline in Short-Form 36-Item Health Survey (SF-36) mental and physical component scores, Personal and Social Performance (PSP) scale and, Kaplan Meier curves of time to study treatment retention. Shifts in severity of PSP score and categories of EuroQol-5D (EQ-5D) were analyzed for rate difference vs. placebo. Results: For AL 441 and 882 mg, placebo-adjusted differences (mean±SE) at endpoint for PSP scores were: 7.8±1.4 and 9.0±1.4 (all p <0.001), and for SF-36 were: physical component 1.8±0.8 (p=0.02) and 2.0±0.8 (p=0.01) and mental component 2.6±1.2 (p=0.03) and 3.9±1.2 (p=0.002). PSP scores improved from severe to mild: 37.0%, 36.6% v. 23.1% (all p=0.03) in AL 441, 882 mg vs. placebo, respectively. Activities and Anxiety/Depression in EQ-5D shifted from moderate/severe/extreme to none/slight at endpoint: 22.7% 24.5% vs. 10.6% (all p≤0.01) in AL 441, 882 mg vs. placebo, respectively. Kaplan Meier curves of time demonstrated greater study retention in AL 441 and 882 mg vs. placebo treatment groups (p<0.001): 58.2%, 55.9% vs. 41.8%. Conclusion: In the 12-week study, treatment with AL was associated with significant improvements in personal and social functioning and health-related quality of life parameters.

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