Aripiprazole Lauroxil 2-Month Formulation for Acute Schizophrenia: A Post Hoc Analysis of PANSS Five-Factor Scores in the ALPINE Study

This work was sponsored by Alkermes, Inc. INTRODUCTION: The randomized, controlled ALPINE study (NCT03345979) evaluated efficacy and safety of aripiprazole lauroxil (AL) every 2 months in patients with acute schizophrenia. Significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores with AL or active control (paliperidone palmitate [PP] monthly) was reported previously. In this post hoc analysis, PANSS five-factor scores (Marder, 1997) were assessed. METHODS AND DESIGN: Adult patients with an acute exacerbation of schizophrenia were enrolled as inpatients, randomized to AL (1064 mg every 2 months) or PP (156 mg monthly), discharged after 2 weeks, and then followed as outpatients through week 25. PANSS five-factor scores at baseline and weeks 4, 9, and 25 were analyzed. Within-group changes from baseline were summarized based on observed data. RESULTS: Of 200 patients randomized to AL (n=99) or PP (n=101), 99 patients (AL, n=56; PP, n=43) completed study treatment. Improvement in PANSS factor scores was observed with AL from baseline to week 25 (mean [95% confidence interval] changes at week 25: positive: −5.4 [−6.5, −4.3]; negative: −3.5 [−4.3, −2.7]; uncontrolled hostility/excitement: −1.9 [−2.5, −1.3]; disorganized thought: −3.4 [−4.2, −2.7]; and anxiety/depression: −3.1 [−3.9, −2.4]). For PP, week 25 PANSS factor improvements were: positive: −6.0 (−6.9, −5.0); negative: −3.4 (−4.3, −2.5); uncontrolled hostility/excitement: −2.2 (−2.8, −1.6); disorganized thought: −4.0 (−4.7, −3.3); and anxiety/depression: −3.5 (−4.3, −2.7). CONCLUSIONS: In patients with schizophrenia treated with AL 1064 mg every 2 months or PP 156 mg monthly, PANSS five-factor scores improved over time, consistent with previously reported changes in PANSS total score.