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Psych Congress  

Work readiness after treatment with aripiprazole once-monthly and paliperidone palmitate: results from QUALIFY, a head-to-head study in schizophrenia

Rachel Self, PhD, MS
Steven G. Potkin, MD
Carlos Forray, MD
Ross A. Baker, PhD, MBA
Phyllis Salzman, PhD
Henrik Steen Andersen, MSc
Anna Eramo, MD
Dieter Naber, MD
Supported by Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S

Objectives: This study compared effectiveness of aripiprazole once-monthly 400 mg (AOM 400) and paliperidone palmitate once-monthly (PP) on symptoms and functioning in patients with schizophrenia. Secondary effectiveness analyses of AOM 400 and PP on the Readiness for Work Questionnaire (WoRQ), a scale measuring socially useful activities, are reported here. Methods: QUALIFY was a 28-week, randomized, open-label, head-to-head study (NCT01795547) of the atypical long-acting injectable anti-psychotics, AOM 400 and PP (flexible dosing 50-150 mg/month as paliperidone [EU and Canada], equvivalent to 78-234 mg/month as paliperidone palmitate [US]). Primary endpoint was Heinrichs-Carpenter Quality-of-Life Scale (QLS) total score analyzed with a mixed model for repeated measures (MMRM). Additional pre-defined endpoints were the clinician-rated WoRQ categorial and total scores assessed with analysis of co-variance and logistic regression and the patient-rated tolerability and quality of life questionnaire (TooL) analyzed with MMRM. Results: The primary analysis showed superior improvements in QLS total score with AOM 400 vs PP (least squares mean [LSM] treatment difference: 4.67, 95%CI:[0.32; 9.02], p=0.036). LSM treatment differences in change from baseline to week 28 on TooL total scores numerically favored AOM 400 vs PP (-0.70, 95%CI:[-1.51;0.12], p=0.095), while significant improvements were found for WoRQ total scores (-1.16, 95%CI:[-1.96,-0.37], p=0.004). At week 28, the odds of being ready to work were higher for AOM 400 vs PP (adjusted odds ratio: 2.67, 95%CI:[1.39; 5.14], p=0.003). Conclusion: Superior improvements on health-related quality of life were accompanied by significant improvements on the clinician-rated WoRQ suggesting that patients' functional capacity increased after AOM 400 vs PP treatment.

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