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Aripiprazole Superior to Paliperidone Palmitate in Improving Quality of Life for Schizophrenia Patients

Head-to-head trial compares once-monthly treatments

 Results have been reported from the QUALIFY trial, which compared two atypical long-acting injectable antipsychotic therapies in a close-to-real-life setting.

The effectiveness of aripiprazole once-monthly (aripiprazole extended-release injectable suspension for intramuscular use [Abilify Maintena], Otsuka America Pharmaceutical, Inc./H. Lundbeck A/S) and paliperidone palmitate (paliperidone palmitate extended-release injectable suspension for intramuscular use [Invega Sustenna], Janssen) in adult patients with schizophrenia was measured by the Heinrichs–Carpenter Quality of Life Scale (QLS) –– the study’s primary endpoint.

QLS is a clinician-rated scale designed to evaluate social functioning and behavior in patients with schizophrenia. It is one of the most commonly used quality-of-life (QOL) scales in schizophrenia clinical trials. The four domains of the QLS evaluate the patient’s intrapsychic foundations (e.g., sense of purpose, motivation, and emotional interaction); interpersonal relations (e.g., social activity and social network); instrumental role (e.g., work functioning and work satisfaction); and common objects and activities. Higher scores indicate better QOL. Additional secondary assessments included the Clinical Global Impression (CGI) scales, which measures symptom severity and treatment response, and the Investigator’s Assessment Questionnaire (IAQ), which was designed to evaluate the patient’s response to antipsychotics.

In the 28-week trial, patients treated with aripiprazole once-monthly demonstrated a statistically significant and superior improvement in the QLS total score compared with those treated with paliperidone palmitate. The mean difference between treatments of the change from baseline to week 28 in the 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 demonstrated by a change in the CGI–Severity scale (used by clinicians to evaluate the overall severity of a patient’s illness; P = 0.004).

Both treatments were generally well-tolerated. Discontinuation rates due to adverse events were 10.8% (16/148) and 18.4% (27/147) for the aripiprazole group and the paliperidone group, respectively.

The QUALIFY trial was a 28-week, randomized, open-label, rater-blinded, head-to-head comparison of intramuscular aripiprazole once-monthly (300 or 400 mg/month) and intramuscular paliperidone palmitate (78 to 234 mg/month [U.S.] or 50 to 150 mg/month [E.U. and Canada]). After a 3-week oral conversion period, when patients received either oral aripiprazole or oral paliperidone, the intramuscular formulations were administered according to approved local instructions for 5 weeks and were continued for 20 weeks. The study design included the provision that if non-inferiority was confirmed, then superiority would be tested. The trial’s primary endpoint was the change in the QLS total score from baseline to week 28. The study included 295 patients in North America and Europe.

Abilify Maintena (aripiprazole) is the only once-monthly injection of a dopamine D2 partial agonist. It is available in the U.S. for the treatment of schizophrenia.

The product, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is provided as a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. After an initial injection of Abilify Maintena along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time.

Source: Otsuka; November 3, 2014.

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