Aripiprazole Lauroxil Every 2 Months or Paliperidone Palmitate Monthly for Acute Schizophrenia: A Post Hoc Analysis of PANSS Five-Factor Scores in the ALPINE Trial.

PURPOSE: The randomized, controlled Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness (ALPINE) study (NCT03345979) evaluated the efficacy and safety of aripiprazole lauroxil (AL) administered every-2-months in patients with schizophrenia. Primary results indicating significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores with AL or active control (paliperidone palmitate [PP] monthly) were reported previously. In this post hoc analysis, treatment effects based on a PANSS five-factor model were assessed.

PATIENTS AND

METHODS

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 in this post hoc analysis. Within-group changes from baseline were summarized by treatment group using the last-observation-carried-forward method for imputation; no formal testing of statistical significance was performed.

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 (standard error [SE]) changes at week 25 were -3.5 (0.42) (negative); -5.4 (0.56) (positive); -3.4 (0.39) (disorganized thought); -1.9 (0.32) (uncontrolled hostility/excitement); and -3.1 (0.37) (anxiety/depression). For PP, week 25 PANSS factor improvements (mean [SE]) for the negative, positive, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression factors were -3.4 (0.48), -6.0 (0.49), -4.0 (0.35), -2.2 (0.30), and -3.5 (0.41), respectively.

CONCLUSION

In this post hoc analysis of patients with acutely exacerbated schizophrenia treated with AL 1064 mg every-2-months or PP 156 mg monthly, numerical improvements in PANSS five-factor scores were observed over time. These results support the primary efficacy findings based on PANSS total score and suggest that efficacy extends to these clinically important symptom domains.