Results announced from the QUALIFY study in schizophrenia

Otsuka Pharmaceutical Europe Ltd. presented the results of the QUALIFY* study, which showed the superiority of Abilify Maintena compared to paliperidone palmitate when using the Heinrichs-Carpenter Quality of Life Scale1 (QLS). The QLS scale assesses the impact of deficit symptoms in schizophrenia on patient reported Health- Related Quality of Life (HRQoL). Results from the study were presented during the 23rd European Congress of Psychiatry (EPA) conference in Vienna, Austria (28-31 March) and the 15th International Congress on Schizophrenia Research in Colorado, USA (28 March-01 April).

The QUALIFY study is a 28-week, open-label, rater-blinded study, in which patients with schizophrenia who needed a change from their current oral antipsychotic treatment were switched to either Abilify Maintena or paliperidone palmitate, another once-monthly atypical antipsychotic.² The primary endpoint results showed a statistically significant difference in improvement from baseline between the two arms to Week 28 on QLS Total score¹ (4.7 [95%CI: 0.3, 9.0], p=0.036), demonstrating non-inferiority to paliperidone palmitate by pre- specified criteria. Subsequently, as planned in the protocol, superiority of Abilify Maintena to paliperidone palmitate was established. The respective changes from baseline to Week 28 were 7.5 ±1.53 for Abilify Maintena and 2.8 ±1.62 for paliperidone palmitate, with higher scores indicating better quality of life.1 Changes above 5.0 on the QLS scale can be described as clinically meaningful, meaning that doctors are able to notice improvements in patients in clinical practice.³ Significant differences between Abilify Maintena and paliperidone palmitate were also observed in improvements in CGI-S score after 28 weeks compared to baseline.¹

Lead investigator Dieter Naber, Professor and former Chairman of the Department of Psychiatry and Psychotherapy at the University Medical Center Hamburg-Eppendorf, said that, "These clinically important results show that Abilify Maintena significantly improves outcomes that are essential to patients, their family and caregivers as well as their physicians, especially when considering the long-term goals of therapy. Improving quality of life in schizophrenia is certainly the most ambitious treatment goal since people with a schizophrenia diagnosis would like to lead a life as similar as possible to those without this chronic condition. These results show physicians that LAIs have a lot to offer in achieving long-term treatment goals that go beyond symptom control.'

The QUALIFY study is the first study to use the QLS scale to compare the effects of two LAIs with different modes of action in schizophrenia. The QLS is a health-related quality of life scale focused on intrapsychic, social, and negative symptoms (i.e. deficit symptoms) and their consequences on quality of life in schizophrenia.⁴ The purpose of the scale is to examine a patient's social experience, work functioning, sense of purpose and motivation and level of participation in the community. ^4,5 Analysis of the deficit symptoms gives an indication of how well a patient is performing on some of the more insidious aspects of the disease.⁴ Combined with existing measures of clinical symptoms, the QLS scale facilitates the careful assessment of the full range of schizophrenic pathology, permitting a comprehensive appraisal of the impact of the illness itself and of efforts to treat it. The QLS scale is the most commonly used quality of life scale in clinical trials for schizophrenia.

In the QUALIFY study, both treatments were generally well-tolerated;discontinuation rates due to adverse events were 11.1% with Abilify Maintena [n=16/144] and 19.7% with paliperidone palmitate [n=27/137]. The most common treatment-emergent adverse events with greater than five percent incidence in either group during the maintenance treatment continuation phase were respectively for Abilify Maintena vs paliperidone palmitate: weight increase (10.1 percent vs 15.6 percent), psychotic disorder (2.5 percent vs 5.5 percent) and insomnia (2.5 percent vs 5.5 percent).¹

Decreased functioning and neurological damage are common consequences of recurring relapses in schizophrenia.^6,7 LAIs have been shown to offer better treatment outcomes, with fewer relapses and hospitalisations than oral antipsychotics.⁸ Future analyses from the QUALIFY study may further explain how patients can benefit from different LAI treatment options.

About the QUALIFY Study

QUALIFY was 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 included 295 patients in Europe and North America.

The primary endpoint assessed non-inferiority and subsequently superiority on change from baseline to week 28 in QLS total score analysed using a mixed model for repeated measurements.

The study design was presented at the New Clinical Drug Evaluation Unit 53rd Annual Meeting in May 2013.

About Abilify Maintena (aripiprazole)

Abilify Maintena is the only long-acting injectable (LAI) antipsychotic that exerts partial agonist activity at the D2 dopamine receptor. It provides physicians with an alternative treatment option, with a tolerability profile comparable to the well-established oral Abilify® (aripiprazole), to address the ongoing need to protect patients with schizophrenia from relapse.

Abilify Maintena is a once-monthly formulation of aripiprazole in a sterile lyophilised powder that is reconstituted with sterile water. After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.⁹

In Europe, Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. Abilify Maintena is available in a number of European countries and is progressing through pricing and reimbursement reviews in the various healthcare authorities that provide access to patients. Abilify Maintena was approved by the US FDA for the treatment of schizophrenia and includes the treatment of acutely relapsed adult patients with schizophrenia in February 2013 and has recently received a marketing authorisation for the maintenance treatment of schizophrenia in stabilised adult patients in Canada and for the maintenance of clinical improvement in the treatment of schizophrenia in Australia.