The effectiveness of aripiprazole once-monthly (aripiprazole extended-release injectable suspension, for intramuscular use: Abilify Maintena) and paliperidone palmitate (paliperidone palmitate extended-release injectable suspension, for intramuscular use) in adult patients with schizophrenia was measured by the Heinrichs-Carpenter Quality of Life Scale (QLS; primary endpoint). QLS is a clinician-rated scale designed to evaluate social functioning and behavior in patients with schizophrenia.ii
The QLS is one of the most commonly used quality-of-life scales in schizophrenia clinical trials. The four domains of the QLS evaluate the patient’s intrapsychic foundations (sense of purpose, motivation, emotional interaction, etc.); interpersonal relations (social activity, social network, etc.); instrumental role (work functioning, work satisfaction, etc.); and common objects and activities. Higher scores indicate better quality of life.
Additional secondary assessments include the Clinical Global Impressions scales (CGI, which measures symptom severity and treatment response), and the Investigator’s Assessment Questionnaire (IAQ, designed to evaluate response to antipsychotics).
In a 28 week trial, patients treated with aripiprazole once-monthly demonstrated a statistically significant and superior improvement in the QLS total score compared to those treated with paliperidone palmitate. The mean difference between treatments of the change from baseline to week 28 in QLS total score was 4.4 (p=0.031) with a respective change of 7.5 for the aripiprazole once-monthly group and 3.1 for the paliperidone palmitate group.
A difference between treatments was also confirmed by a change in the Clinical Global Impression-Severity Scale (CGI-S, used by clinicians to evaluate the overall severity of a patient’s illness; p=0.004). Both treatments were generally well-tolerated, however discontinuation rates due to adverse events were 10.8% (n=16/148) vs. 18.4% (n=27/147), for aripiprazole once-monthly group vs paliperidone once-monthly group, respectively.
QUALIFY is a 28 week, randomized, open-label, rater-blinded, head-to-head comparison of intramuscular aripiprazole once-monthly (400 or 300 mg/month) and intramuscular paliperidone palmitate (50 to 150 mg/month (EU and Canada) or 78 to 234 mg/month (US).
After a three-week oral conversion period when patients received either oral aripiprazole or oral paliperidone, the intramuscular formulations were administered according to approved local instructions (EU Summary of Product Characteristics or US Package Insert) during five weeks and continued for 20 weeks.
The study design included that if non-inferiority was confirmed then superiority would be tested. The primary endpoint was the QLS total score change from baseline to week 28. The study included 295 patients in Europe and North America.
The study design was presented at the New Clinical Drug Evaluation Unit 53rd Annual Meeting in May 2013. Data from the QUALIFY study will be presented at upcoming medical congresses and in scientific publications.