The key findings of this open-label, non-randomised, European multicentre trial were presented today at the XXIVth CINP Congress – Collegium Internationale Neuro-Pychopharmacologicum in Paris, France1.
"These results are important because they suggest that changing patients' medication to an atypical, long-acting injectable treatment could result in further improvements in symptom control," said Professor Pierre Michel Llorca, Chairman of the Department of Psychiatry, University Hospital, Clermont-Ferrand, France. "Furthermore, a long-acting injectable treatment can benefit those patients early on in the disease, who have difficulties complying with their medication."
In this study, 119 adults diagnosed with schizophrenia for up to five years (mean duration of illness 2.4 years), who had received previous antipsychotic therapy (60 percent atypical antipsychotics, 28 percent conventional depot and 10 percent conventional oral neuroleptics), were transitioned to risperidone long-acting injection for various reasons, including non-compliance (45 percent) or adverse events with previous medication (29 percent).
The results from the study found that positive and negative symptoms of schizophrenia improved and continued to improve during the six months of treatment with risperidone long-acting injection, as measured by the PANSS. At endpoint, more than one-third (35 percent) of these patients had an improvement of more than 20 percent in the PANSS total score.
Patients also showed a significant improvement on the Clinical Global Impression-Severity (CGI-S)** scale that was maintained throughout the six-month trial. The proportion of patients treated with risperidone long-acting injection who were 'not ill' or 'borderline ill' increased from 8 percent at the beginning to 32 percent at the end of the trial.
In addition, the health status of the patients treated with risperidone long-acting injection and their satisfaction improved at the end of the study with the proportion of patients who rated their satisfaction as 'very good' increasing from 5.9 percent to 33.7 percent.
An estimated one percent of the world's population suffers from schizophrenia2, a brain disorder that impairs a person's ability to think clearly, relate to others, and distinguish between reality and imagination. It typically develops in adolescence or the early 20s, although symptoms may not become obvious until later life. People who suffer from schizoaffective disorder experience both severe mood swings, such as mania and/or depression, and some of the psychotic symptoms of schizophrenia. Schizophrenia is marked by "positive" symptoms and "negative" symptoms. "Positive" symptoms are psychological disturbances "added" as a result of the disorder, such as hallucinations, delusions, suspiciousness and paranoia. "Negative" symptoms refer to normal functioning the patient has "lost," resulting in lack of initiative, social withdrawal, lack of expression and emotional withdrawal.
RISPERDAL(R) CONSTA(TM) is the first and only new generation, 'atypical' antipsychotic available as a long-acting injection. It combines the increased efficacy and fewer side effects of an atypical antipsychotic with the benefits of a long-acting formulation. RISPERDAL(R) CONSTA(TM) only needs to be given every two weeks, so patients do not have to worry about remembering to take their medication every day.
RISPERDAL(R) CONSTA(TM) is marketed in most parts of the world by Janssen-Cilag, and has been approved to date in more than 60 countries for the treatment of schizophrenia. The drug was developed by Johnson & Johnson Pharmaceutical Research & Development using a novel technology originated by U.S.-based Alkermes, Inc., in which risperidone is embedded in tiny spheres of biodegradable polymer ("microspheres") that gradually degrade at a controlled rate following intramuscular injection.
For further information, contact:
Brigitte Byl
Johnson & Johnson
Global Pharmaceutical Communications
Europe, Middle-East, Africa
32-0-2-749-2772 (Belgium)
Bbyl@gpcbe.jnj.com
Notes to editors:
The tradename, regulatory status of medicines and potential indications as discussed in these materials may vary from country to country.
The Janssen-Cilag companies, which are members of the Johnson & Johnson (NYSE:JNJ) family of companies, one of the world's most diversified healthcare corporations, have a long track record in developing and marketing treatments for central nervous system disorders, pain management, fungal infections and gastrointestinal conditions. Leading products include CONCERTA(R) (ADHD), DUROGESIC(R) (pain management), EPREX(R) (anemia), PARIET(R) (gastroenterology), TOPAMAX(R) (epilepsy), REMINYL(R) (Alzheimer's disease), RISPERDAL(R) (schizophrenia, acute bipolar mania, behavioural psychological symptoms of dementia, disruptive behaviour disorders) and RISPERDAL(R) CONSTA
Study details:
As part of the StoRMi clinical study - an open-label, non-randomised, European multicentre study - a sub-group analysis was performed in 119 patients with a short duration of illness (1-5 years) who had been stable on their previous antipsychotic treatment for more than one month. Patients received two-weekly intramuscular injections of long-acting risperidone 25mg (increased to 37.5 or 50 mg, if necessary) for six months.
*PANSS measures the severity of both 'negative' symptoms and 'positive' symptoms.
**The Clinical Global Impression-Severity (CGI-S) scale is a general psychiatry rating scale and refers to the physician's global impression of the patient.
References:
1. Christensen TB, Kissling WK, Lex A, Parellada E. Direct Switching to Risperidone Long-acting Injectable: Experience in Patients Early in the Course of the Disease. Poster presented at the CINP, Paris, France, 2004.
2. Chua SE, Lam WS, Tai KS et al. Brain morphological abnormality in schizophrenia is independent of country of origin. Acta Psychiatrica Scandinavica 2003; 108(4): 269-275.