Nearly half of patients
with schizophrenia fail to remain on their medication treatment, which can
result in a relapse of symptoms (1,2). Today, data from a new international
study showed that patients treated with risperidone long-acting injection
(RLAI) had a significantly longer time to relapse (3) compared to patients
treated with an oral atypical medication, quetiapine.
The results were presented for the first time at the American
Psychiatric Association (APA) 161st Annual Meeting in Washington, D.C.
This 24-month, open-label, active-controlled, comparative international
study, was the largest since the 1979 Hogarty study(4) to compare the
relapse rates of a long-acting injectable antipsychotic and an oral
medication. The objective of the trial was to compare longer-term
maintenance therapy of patients with schizophrenia or other related
disorders (schizoaffective disorder) treated with RLAI or quetiapine.
"This study provides compelling evidence that RLAI offers a significant
benefit to people with schizophrenia in delaying the time to relapse," said
Professor Wolfgang Gaebel from the Department of Psychiatry and
Psychotherapy at the Heinrich-Heine University in Dusseldorf, Germany and
one of the study investigators.
This international study, which enrolled 710 patients (355 randomized
to received RLAI [mean dose 32.75 mg] and 355 to receive quetiapine [mean
dose 397 mg]), investigated whether treatment with RLAI compared with oral
quetiapine, when tested in a routine care setting within general
psychiatric services, had an effect on long-term efficacy maintenance as
measured by time to relapse.(5)
Results demonstrated that the average relapse-free time was
significantly longer in patients treated with RLAI (607 days) compared with
quetiapine (533 days), p
The study was sponsored by Janssen-Cilag, Medical Affairs EMEA.
Separately, an interim analysis from a two-year U.S. observational
study also presented today at APA showed patients taking RLAI had
significantly improved functioning within three months after starting
treatment. That study enrolled 532 patients from 66 community health
centers and Veterans Affairs centers in the United States. Data collection
occurred at baseline (month 0) and then every three months up to the two
years. At the time of this interim analysis, 107 patients had completed the
full two-year period.(7)
The U.S. interim analysis showed an overall significant improvement in
patient functioning from serious to occasional impairments following
initiation of RLAI (p