Study Shows Effects of Treatment With Abilify Maintena (Aripiprazole) on Psychiatric Hospitalization Rates in Schizophrenia Patients
Hospitalizations are significantly reduced compared with patients receiving oral antipsychotics
Results from a preliminary analysis have shown statistically significant reductions (P < 0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly Abilify Maintena (Otsuka Pharmaceutical Co./H. Lundbeck) — an extended-release injectable suspension formulation of aripiprazole — compared with previous treatment with daily standard-of-care (SOC) oral antipsychotics.
The data were presented at the 166th American Psychiatric Association (APA) Annual Meeting in San Francisco in May, and were published in the Journal of Medical Economics.
The multicenter, open-label, North American study assessed total psychiatric hospitalization rates (defined as the proportion of patients with one or more inpatient psychiatric hospitalizations). The study was divided into two treatment periods: the first was a retrospective, 6-month period that assessed total psychiatric hospitalization rates in stable adult patients with schizophrenia treated with oral SOC antipsychotics; the second treatment period included the same patients, who were then converted to treatment with Abilify Maintena 400 mg once monthly for 6 months in the following prospective phases:
- Phase A (1 to 4 weeks): a conversion phase in which patients cross-titrated from their current oral antipsychotic to oral aripiprazole;
- Phase B (24 weeks): an open-label treatment phase where patients received Abilify Maintena (400 mg with an option to decrease to 300 mg for tolerability). As part of the study design, patients also received concomitant oral aripiprazole for the first 14 days of Phase B; and:
- Phase C: an ongoing extension phase.
A total of 183 patients entered the prospective Phase B of the study, with 121 completing 3 months or more of treatment with Abilify Maintena.
The total psychiatric hospitalization rate for the retrospective 3-month analysis period, in which patients received oral SOC antipsychotics, was 28.1% (34/121) compared with a hospitalization rate of 6.6% (8/121) during the last 3 months of the prospective analysis period with Abilify Maintena (P < 0.0001). The total psychiatric hospitalization rate for the retrospective 6-month analysis period, in which patients received oral antipsychotics, was 41.5% (76/183) compared with a hospitalization rate of 14.2% (26/183) for all patients who entered Phase B of the 6-month prospective analysis period with Abilify Maintena (P < 0.0001).
The most common treatment-emergent adverse events observed during the prospective Phase B were psychotic disorder (7.7%), insomnia (7.2%), akathisia (7.2%), and schizophrenia, paranoid type (5.5%). The incidence of weight change was 2.2% gained weight and 2.2% lost weight.