Otsuka Pharmaceutical Europe Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that a newly released subgroup analysis of data from the QUALIFY study 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 QLS total scores between aripiprazole once-monthly and paliperidone palmitate of 10.7 points was observed in patients aged 18-35 years (p=0.037). 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 (difference in change of 4.7 points, p=0.036). 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 (QLS, IAQ, CGI-S). This suggests that treatment with aripiprazole once-monthly may confer better treatment outcomes than with paliperidone palmitate in this patient subgroup..
Aripiprazole once-monthly is the only long-acting injectable (LAI) antipsychotic that exerts partial agonist activity at the D2 dopamine receptor. In European Union aripiprazole once-monthly is indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole (indication might differ and must be checked for other countries). Aripiprazole once-monthly is a once-monthly formulation of aripiprazole in a sterile lyophilized powder that is reconstituted with sterile water and the recommended starting and maintenance dose is 400mg. 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.
