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Psych Congress  

Effects of aripiprazole once-monthly and paliperidone palmitate on QLS domain scores: results from QUALIFY, a randomized, head-to-head clinical study

Authors  
Stephen F. Murray, PharmD, MBA
Steven Potkin, MD
Carlos Forray, MD
Ross A. Baker, PhD, MBA
Henrik Steen Andersen, MSc
Anna Eramo, MD
Dieter Naber, MD
Sponsor  
Supported by Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S

Objectives: Aripiprazole once-monthly 400 mg (AOM 400) was compared to paliperidone palmitate once-monthly (PP) on Heinrichs-Carpenter Quality-of-Life Scale (QLS), a validated measure of intrapsychic, interpersonal, and instrumental functioning in patients with schizophrenia. Pre-defined secondary analyses assessed effects of AOM 400 and PP on individual QLS domains. Methods: QUALIFY was a 28-week, open-label, rater-blinded, head-to-head study (NCT01795547) of the atypical long-acting injectable antipsychotics, AOM 400 and PP (50-150 mg/month as paliperidone [EU and Canada], 78-234 mg/month as paliperidone palmitate [US]). The primary endpoint was QLS total score analyzed with a mixed model for repeated measures (MMRM). Changes from baseline in QLS domains (interpersonal relations, instrumental role, intrapsychic foundations, and common objects and activities) were assessed with MMRM. Results: The primary analysis showed superior improvements with AOM 400 vs PP on QLS total score from baseline to week 28 with least squares mean (LSM) treatment differences of 4.67 (95%CI:[0.32;9.02], p=0.036). Improvements in QLS domain scores within intrapsychic foundations were significantly greater with AOM 400 vs PP (LSM treatment difference: 1.8, 95%CI:[0.09;3.4], p=0.039). LSM treatment differences numerically favored AOM 400 vs PP in remaining QLS domains (Interpersonal relations: 1.8, 95%CI:[-0.14;3.7], p=0.070; Instrumental role: 0.92, 95%CI:[-0.28;2.1], p=0.13; Common objects and activities: 0.33, 95%CI:[-0.12;0.78], p=0.15). Conclusion: Superior improvements in health-related quality of life and functioning for AOM 400 vs PP were demonstrated in patients with schizophrenia. QLS domain analyses suggest that improvements in underlying intrapsychic foundations, such as sense of purpose, curiosity and empathy, may facilitate greater functioning with AOM 400 vs PP.

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