New data released from QUALIFY study of aripiprazole once-monthly

Otsuka and Lundbeck have announced newly released subgroup analysis of data from the QUALIFY study of Abilify Maintena (aripiprazole once-monthly).

The data showed significantly greater and clinically meaningful improvements in functioning and health-related quality of life (HRQoL) with aripiprazole once-monthly compared with paliperidone palmitate in patients aged 18-35 years living with schizophrenia.

A difference in improvement in Heinrichs-Carpenter Quality of Life Scale (QLS) total scores between aripiprazole once-monthly and paliperidone palmitate of 10.7 points was observed in patients aged 18-35 years. Changes of more than five points in the QLS total scores are considered clinically meaningful, i.e. physicians should be able to notice these changes in their patients in clinical practice. Superiority of aripiprazole once-monthly compared with paliperidone palmitate in the study’s primary endpoint  was also observed in the total QUALIFY study population. The positive effect of aripiprazole once-monthly compared with paliperidone palmitate in the subgroup of patients aged 18-35 years was consistently seen across a range of effectiveness measures. This suggests that treatment with aripiprazole once-monthly may confer better treatment outcomes than with paliperidone palmitate in this patient subgroup.

Aripiprazole once-monthly may be beneficial in improving patients’ ability to do better in social- and work- related environments

“These latest findings from the QUALIFY study are particularly encouraging for young adults  with schizophrenia who are in the formative years of their lives, a time during which many complete school, establish a career, build personal relationships, and start a family,” said investigator Steven G. Potkin, of the Department of Psychiatry and Human Behaviour, University of California. “The study findings indicate that treatment with aripiprazole once-monthly in adult patients aged 35 years and younger may be particularly beneficial in improving these patients’ abilities to do better in social, home, and work or education-related environments.”

The subgroup analysis also showed that younger adult patients had a significantly greater reduction in disease severity with aripiprazole once-monthly compared with paliperidone palmitate as assessed by the Clinical Global Impression-Severity scale, and showed significantly greater relative effectiveness as assessed by the Investigator’s Assessment Questionnaire (IAQ).