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Psych Congress  

Aripiprazole once-monthly is superior to paliperidone palmitate: results from QUALIFY, a randomized, head-to-head clinical study in schizophrenia

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

Objective: The QUALIFY study directly compared treatment effectiveness of aripiprazole once-monthly 400 mg (AOM 400) and paliperidone palmitate once-monthly (PP) on the Heinrichs-Carpenter Quality-of-Life Scale (QLS), a validated measure of functioning in patients with schizophrenia. Methods: QUALIFY was a 28-week, randomized, open-label, rater-blinded, head-to-head study (NCT01795547) comparing AOM 400 and PP (50-150 mg/month as paliperidone [EU and Canada], 78-234 mg/month as paliperidone palmitate [US]). The study comprised oral conversion, then initiation of AOM 400 or PP treatment, followed by 5 monthly injections. The study was a non-inferiority study allowing for subsequent pre-defined testing for superiority. The primary endpoint was change from baseline to week 28 on QLS total score analyzed with a mixed model for repeated measures. Results: Of 295 randomized patients, 67.6% (100/148) on AOM 400 and 56.5% (83/147) on PP completed 28 weeks of treatment. At week 24, mean±SE dose was 387±3.4 mg AOM and 172±5.6 mg PP as paliperidone palmitate. The least squares mean difference between treatments in change from baseline to week 28 on QLS total score was 4.67 (95%CI: 0.32-9.02, p=0.036), confirming non-inferiority and establishing superiority of AOM 400 vs PP. Adverse events occurring in ≥5% of patients in the treatment continuation were weight gain, psychotic disorder, and insomnia; all were less frequent with AOM 400 vs PP. Conclusions: Superior improvements on health-related quality of life and functioning as measured by the clinician-rated QLS and numerically lower rates of all-cause discontinuation suggest greater overall effectiveness for AOM 400 vs PP.

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