Date: 2014-11-03
Type of information: Results
phase:
Announcement: results
Company: Lundbeck (Denmark) Otsuka Pharmaceutical (Japan)
Product: Abilify Maintena® (aripiprazole extended-release injectable suspension, for intramuscular use)
Action
mechanism: Abilify Maintena® (aripiprazole once-monthly) is the first and only once-monthly injection of a dopamine D2 partial agonist. It is available in a number of European countries for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. Furthermore, it is available in the US for the treatment of schizophrenia. In Canada it is available for the maintenance treatment of schizophrenia in stabilised adult patients and in Australia for maintenance of clinical improvement in the treatment of schizophrenia.
Disease: schizophrenia
Therapeutic area: Mental diseases
Country:
Trial
details: QUALIFY is a randomized, open-label rater-blinded, head-to-head comparison of intramuscular aripiprazole once-monthly (400 or 300 mg/month) and intramuscular paliperidone palmitate injection (50 to 150 mg/month (EU) or 78 to 234 mg/month (US and Canada)) over 28 weeks. The study was designed as a non-inferiority study, allowing for subsequent superiority testing, if non-inferiority criterion was met. After a minimum of 3-week oral conversion period where patients received either oral aripiprazole or oral paliperidone, the intramuscular formulations were administered according to the prescribing information for five weeks and continued for 20 weeks. The primary endpoint was the QLS total score change from baseline to week 28. The study randomized 295 patients in Europe and North America of which 281 received study treatment.
Latest
news: * On November 3, 2014, Lundbeck and Otsuka America Pharmaceutical announced results from the QUALIFY study; the first study of its kind comparing two atypical long-acting injectable anti-psychotic therapies (aripiprazole, paliperidone palmitate). in a close-to-real life setting. The effectiveness of aripiprazole (aripiprazole extended-release injectable suspension, for intramuscular use, Abilify Maintena®) and paliperidone palmitate once-monthly (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 clinician-rated scale designed to evaluate social functioning and behaviour in patients with schizophrenia.
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), the Investigator\'s Assessment Questionnaire (IAQ, designed to evaluate response to antipsychotics) and the Subjective Well-being under Neuroleptic Scale — short version (SWN-S, a self-rating scale for patients on antipsychotic drugs).
In a 28 week trial, patients treated with aripiprazole once-monthly demonstrated a statistically significant improvement in the QLS total score compared to patients treated with paliperidone palmitate once-monthly. 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 once-monthly 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 severity of a patient\'s illness) from baseline to 28 weeks of treatment (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. Data from the QUALIFY study will be presented at upcoming medical congresses and in scientific publications.
