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

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.