Psychiatric hospitalization rate decreases among adults with schizophrenia treated with INVEGA SUSTENNA: Study

Nov 20 2010

Schizophrenia is a chronic and disabling brain disorder that affects 1 percent of the U.S. population and results in substantial medical and societal costs, in particular from use of health-care resources. It also can have devastating health-related and social effects on people with the disease, their families and caregivers.

A pre-specified analysis from a longer-term clinical study presented at the U.S. Psychiatric and Mental Health Congress today suggests that psychiatric hospitalization rates decreased for adults with schizophrenia who were treated with INVEGA® SUSTENNA® (paliperidone palmitate), a long-acting atypical antipsychotic for acute and maintenance treatment of schizophrenia in adults.

"This study suggests that INVEGA SUSTENNA may have potential to reduce psychiatric hospitalization rates," said Chris M. Kozma, PhD, independent researcher and adjunct professor, University of South Carolina, Columbia, and consultant for Ortho-McNeil Janssen Scientific Affairs, L.L.C., the sponsor of the study.  "While the results will need further investigation to confirm these observations, a treatment that can potentially lead to reduced hospitalizations for schizophrenia may offer economic benefits to health-care systems that pay for schizophrenia-related inpatient care."

Study Methods

Data for the analysis were from two phases of the clinical trial: a double-blind, randomized, relapse-prevention maintenance phase that compared INVEGA SUSTENNA to placebo and a one-year open-label extension of the study, during which all patients were treated with INVEGA SUSTENNA.

The change in schizophrenia-related hospitalization rates between the two phases of the study was evaluated for the group of patients treated with INVEGA SUSTENNA and for the group that received placebo. Data were obtained from an investigator-completed resource-use questionnaire. Overall change in hospitalization rates using all patients also was analyzed. A statistical analysis known as Poisson regression was used to evaluate changes in incidence of hospitalization over time and by the duration of each patient's schizophrenia diagnosis.

Results

There were 160 patients in the randomized INVEGA SUSTENNA-to-open label INVEGA SUSTENNA group and 153 patients in the randomized placebo-to-open label INVEGA SUSTENNA group.  The average age, gender and duration of schizophrenia diagnosis were similar at the start of the double blind phase for both groups. For the placebo group the average age was 38.5 years, 51 percent of the patients were male and 32 percent had schizophrenia for five or more years. For the INVEGA SUSTENNA group, the average age was 37.3 years, 51.9 percent were male and 30 percent has schizophrenia for five years or more.

During treatment with open-label INVEGA SUSTENNA, the number of hospitalizations per person-year for patients treated during the double-blind phase with placebo significantly declined from 0.27 to 0.06, or a 78 percent reduction (P<0.0047).  For those patients who were treated during the double-blind phase with INVEGA SUSTENNA and continued on INVEGA SUSTENNA during the open label phase, there was a decline in hospitalization rates from 0.11 to 0.04 (a 64 percent reduction, but this was not statistically significant (P<0.0758). Overall, the change in hospitalization rates from prior to initiation of treatment to the open label extension>