Multidimensional Assessment of Functional Outcomes in Schizophrenia: Results From QUALIFY, a Head-to-Head Trial of Aripiprazole Once-Monthly and Paliperidone Palmitate

Steven G Potkin, Jean-Yves Loze, Carlos Forray, Ross A Baker, Christophe Sapin, Timothy Peters-Strickland, Maud Beillat, Anna-Greta Nylander, Peter Hertel, Simon Nitschky Schmidt, Anna Eramo, Karina Hansen, Dieter Naber, Steven G Potkin, Jean-Yves Loze, Carlos Forray, Ross A Baker, Christophe Sapin, Timothy Peters-Strickland, Maud Beillat, Anna-Greta Nylander, Peter Hertel, Simon Nitschky Schmidt, Anna Eramo, Karina Hansen, Dieter Naber

Abstract

Background: QUALIFY was a 28-week, randomized, open-label, head-to-head trial that assessed improvements across multiple measures in stable patients with schizophrenia with aripiprazole once-monthly 400 mg vs paliperidone palmitate.

Methods: Secondary effectiveness assessments included physician-rated readiness for work using the Work Readiness Questionnaire, the Clinical Global Impression-Severity and Clinical Global Impression-Improvement scales, and quality of life with the rater-blinded Heinrichs-Carpenter Quality of Life Scale. Patients assessed their treatment satisfaction and quality of life with Subjective Well-Being under Neuroleptic Treatment-short version and Tolerability and Quality of Life questionnaires.

Results: Odds of being ready for work at week 28 were significantly higher with aripiprazole once-monthly 400 mg vs paliperidone palmitate (adjusted odds ratio, 2.67; 95% CI, 1.39-5.14; P=.003). Aripiprazole once-monthly 400 mg produced numerically or significantly greater improvements from baseline vs paliperidone palmitate in all Quality of Life Scale items. With aripiprazole once-monthly 400 mg vs paliperidone palmitate at week 28, there were significantly more Clinical Global Impression-Severity and Clinical Global Impression-Improvement responders (adjusted odds ratio, 2.26; P=.010, and 2.51; P=.0032) and significantly better Clinical Global Impression-Improvement scores (least squares mean treatment difference, -0.326; 95% CI, -0.60 to -0.05; P=.020). Numerically larger improvements with aripiprazole once-monthly 400 mg vs paliperidone palmitate were observed for patient-rated scales Subjective Well-Being under Neuroleptic Treatment-short version and Tolerability and Quality of Life. Partial correlations were strongest among clinician-rated and among patient-rated scales but poorest between clinician and patient-rated scales.

Conclusions: Consistently greater improvements were observed with aripiprazole once-monthly 400 mg vs paliperidone palmitate across all measures. Partial correlations between scales demonstrate the multidimensionality of various measures of improvement. More patients on aripiprazole once-monthly 400 mg were deemed ready to work by the study end.

Trial registry: National Institutes of Health registry, NCT01795547, https://ichgcp.net/clinical-trials-registry/NCT01795547).

Keywords: aripiprazole once-monthly; functioning; paliperidone palmitate; quality of life; schizophrenia.

© The Author 2016. Published by Oxford University Press on behalf of CINP.

Figures

Figure 1.
Figure 1.
Distribution of aripiprazole once-monthly 400 mg (AOM 400) and paliperidone palmitate once-monthly (PP) doses by treatment week in the all-patients-treated set (i.e., all patients randomized who took ≥1 dose of study medication). Percentages of patients receiving each dose is given above each bar, numbers below the axes refer to number of treated patients in the given treatment week. PP doses refer to paliperidone (50, 75, 100, and 150 mg [EU]) equivalent to paliperidone palmitate (78, 117, 156, and 234 mg [US]).
Figure 2.
Figure 2.
Change from baseline at week 28 on Heinrichs-Carpenter Quality of Life Scale (QLS) items. Full analysis set. Results are shown for (a) the first 12 items on the scale and (b) the last 9 items on the scale. AOM 400, aripiprazole once-monthly 400 mg; PP, paliperidone palmitate once-monthly. *P<.05.
Figure 3.
Figure 3.
Distribution of Clinical Global Impressions–Improvement (CGI-I) scores at week 28. Full analysis set. 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse. Patients with CGI-I scores of 1 or 2 at week 28 were considered to be responders. AOM 400, aripiprazole once-monthly 400 mg; PP, paliperidone palmitate once-monthly.
Figure 4.
Figure 4.
Shift from baseline in readiness for work status among (a) the full analysis set and (b) patients not ready for work at baseline. Shift analysis was based on the WoRQ readiness to work question (item 8) at baseline and week 28: Based on your clinical judgment, is this patient ready for work?
Figure 5.
Figure 5.
Change from baseline to week 28 in patient-rated (a) Subjective Well-Being Under Neuroleptics–short version (SWN-S) total and subscale scores and (b) Tolerability and Quality of Life (TooL) total score. Full analysis set. AOM 400, aripiprazole once-monthly 400 mg; FAS, full analysis set; LS, least squares. *n=83 for the PP treatment group.

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Source: PubMed

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