RISPERIDONE LONG-ACTING INJECTION (RLAI) IN THE TREATMENT OF SCHIZOPHRENIA- 12 MONTH PRELIMINARY RESULTS FROM E-STAR PROJECT IN CZECH REPUBLIC AND SLOVAKIA

Author(s)

Annette Lam, MHE, Manager, Health Economics and Pricing1, J Pecenak, MD, Psychiatrist2, Ivan Tuma, MD, Psychiatrist3, Michael Povey, PhD, Senior Biostatistician41Johnson and Johnson Pharmaceutical Services, Toronto, ON, Canada; 2 FNSP Bratislava, Bratislava, Slovak Republic; 3 FNSP Hradec Kralove, Hradec Kralove, Czech Republic; 4 SGS Life Science Services Belgium, Wavre, Belgium

OBJECTIVES: To assess the outcomes in patients initiated on risperidone long-acting injection (RLAI) enrolled in the electronic-Schizophrenia Treatment Adherence Registry (e-STAR) and were followed for 12-months in the Czech Republic and Slovakia. METHODS: E-STAR is a secure web-based, international, observational study of patients with schizophrenia who have been initiated with RLAI. Data are collected both retrospectively (1 year) and prospectively (2 years) including hospitalisations and reasons for treatment initiation; patients are prospectively evaluated every 3 months using the Clinical Global Impression Severity Scale (CGI-S) and Global Assessment of Functioning Scale (GAF). RESULTS: To date a combined total of 1068 patients have been enrolled into e-STAR in the Czech Republic and Slovakia; 280 patients have been followed for at least 12-months (156 Czech Republic, 124 Slovakia). Of the 280 patients, the majority were male (57.9%) with a diagnosis of schizophrenia or schizoaffective disorder (85.7%, 14.3% respectively) with a mean age of 37±12.1 years and a mean time since diagnosis of 9.2±9 years. At 12-months, 96.4% of patients remained on RLAI treatment. 85.4% of patients were initiated on 25mg of RLAI at baseline and at 12-months 54.6% were still on 25mg. Compared to the 12-month retrospective period, significant decreases were seen in the 12-month prospective period in the proportion of patients hospitalized (50% vs. 17.5%, respectively; p<0.001), the mean number of hospitalizations per patient (0.65 vs. 0.23, p<0.001), and the mean number of days in hospital (29.6 vs. 7.7, p<0.001). Significant improvements from baseline to 12 months were seen in both the average CGI-S score (4.56 to 3.03, p<0.001) and GAF score (48.7 to 71.3, p<0.001). CONCLUSION: Significant improvement in disease severity and functioning and decrease in use of hospital services in patients with schizophrenia treated with RLAI were observed in this 12-month interim analysis. Follow-up is ongoing until 24 months.

Conference/Value in Health Info

2007-10, ISPOR Europe 2007, Dublin, Ireland

Value in Health, Vol. 10, No. 6 (November/December 2007)

Code

PMH11

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes

Disease

Mental Health

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