NEW YORK, May 5 /PRNewswire/ -- New clinical findings show that many people with schizophrenia, deemed symptomatically stable, experienced further improvements in symptom control when transitioned to treatment with RISPERDAL(R) CONSTA(TM) (risperidone) long-acting injection from their previous medication. The findings were presented today at the 157th Annual Meeting of the American Psychiatric Association.
More than two million Americans suffer from schizophrenia, a brain disorder that impairs a person's ability to think clearly, relate to others and distinguish between reality and imagination.
"Many patients achieve symptom stability with available medications," said Wim J. Arnoldussen, M.D., case management psychiatrist and neurologist at GGzE Case Management, Eindhoven, The Netherlands. "In our study, we found the number of patients treated with Risperdal Consta categorized as 'not ill' or 'very mild' nearly doubled by the end of the study."
The findings of improved symptom control provided by Risperdal Consta come from multiple sources. The first data(1) are from a pre-planned analysis of 119 patients treated for six months during a European study of Risperdal Consta.
Researchers rated patients and their symptoms utilizing the Clinical Global Impression-Severity (CGI-S) scale at baseline and at endpoint, classifying them into levels of relative "wellness," including "not ill," "very mild" or "mild" up to "severely ill."
At the study endpoint, a significant improvement was seen in CGI-S levels, with 14 percent considered "not ill" at endpoint versus 2 percent at baseline. In addition, approximately 22 percent were considered "very mild" (versus approximately 11 percent, baseline) and approximately 16 percent were considered "mild" (versus approximately 21 percent, baseline). Baseline medications include various oral antipsychotic agents.
At endpoint, the mean total efficacy measure or Positive and Negative Syndrome Scale (PANSS) score decreased significantly. Thirty-one percent of these already stable patients showed an improvement in total PANSS scores of at least 20 percent when compared with baseline -- regarded as a clinically relevant response among those patients with a stable baseline condition.
PANSS is a common measure of the total severity of positive symptoms (psychological disturbances "added" as a result of the disorder, such as hallucinations, delusions, suspiciousness and paranoia) and negative symptoms (normal functioning the patient has "lost," resulting in lack of initiative, social withdrawal, lack of expression and emotional withdrawal).
Patients' ability to function was measured using the Global Assessment of Function (GAF), while patient satisfaction was recorded on a five-point scale: very good, good, reasonable, moderate or poor. At the study endpoint, patients' GAF scores improved significantly, from 56 at baseline to 62 at endpoint, while the proportion of patients expressing satisfaction with their treatment increased from 53 percent at baseline to 65 percent.
Safety and tolerability were assessed using the Extrapyramidal Symptom Rating Scale (ESRS) and adverse events were recorded during the study. Changing treatment to Risperdal Consta from prior medication was associated with significant decreases in the total ESRS and parkinsonism subscale scores. No unexpected adverse events were observed during the study.
Subjects were aged 18 years and older; a majority diagnosed with schizophrenia or a schizoaffective disorder. All participants had been symptomatically stable on a constant dose of their previous medication for at least one month before enrollment in the study, and were able to transition to Risperdal Consta. Some patients had received more than one antipsychotic medication prior to the study.
Additional Studies Supporting Clinical Benefits of Risperdal Consta
Two additional studies(2), (3) demonstrating the clinical benefits of Risperdal Consta were presented at the 157th Annual Meeting of the American Psychiatric Association. These studies showed that many symptomatically stable schizophrenia patients who previously had been treated with olanzapine or quetiapine oral atypical antipsychotic medications experienced further improvements in symptoms following treatment with Risperdal Consta.
In both studies, patients received Risperdal Consta every two weeks for 12 weeks. Symptoms were assessed using both CGI-S and PANSS scores:
* In the Risperdal Consta study of patients previously treated with
olanzapine (n=50) (2), the proportion of patients with CGI-S ratings of
"very mild" to "mild" increased from 56 percent at baseline to 63
percent at endpoint; in the Risperdal Consta study of patients
previously treated with quetiapine (n=45) (3), patients with CGI-S
ratings of "very mild" to "mild" increased from 28 percent at baseline
to 58 percent at endpoint.
* Although patients were judged clinically stable at study entry, further
clinical improvement (greater than or equal to 20 percent reduction in
PANSS total scores) was achieved by 44 percent of patients previously
treated with olanzapine and 35 percent of patients previously treated
with quetiapine.
* When assessed by the ESRS, the severity of patients' extrapyramidal
symptoms did not change throughout both 12-week trials.
* Adverse events reported in more than 15 percent of patients who
previously had received quetiapine included headache (29 percent),
insomnia (18 percent), agitation (18 percent) and anxiety (16 percent).
In patients who had previously received olanzapine, adverse events
occurring in more than 5 percent of patients included insomnia (20
percent), rhinitis (10 percent), psychosis (8 percent), headache (6
percent), agitation (6 percent) and hyperprolactinemia (6 percent).
Financial support for these studies and analyses were provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Janssen-Cilag Medical Affairs EMEA and Janssen Medical Affairs, L.L.C.
Risperdal Consta is the first and only long-acting, newer-generation (atypical) antipsychotic to be approved by the U.S. Food and Drug Administration and is now approved in more than 57 countries worldwide. The treatment uses advanced technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Risperdal Consta is manufactured by Alkermes, Inc., and marketed in the United States by Janssen Pharmaceutica Products, L.P. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia. For more information, please visit http://www.risperdalconsta.com/.
In clinical trials, Risperdal Consta was generally well-tolerated. The most common treatment-emergent adverse events with an incidence of 5 percent or greater in at least one of the Risperdal Consta groups (25 mg or 50 mg) and at least twice that of placebo were: somnolence, akathisia, parkinsonism,* dyspepsia, constipation, dry mouth, fatigue and weight increase. As with all antipsychotic medications, prescribing should be consistent with the need to minimize the risk of tardive dyskinesia, a neurological side effect that can include repetitive twitching; if its signs and symptoms appear, discontinuation of Risperdal Consta should be considered. In the integrated database of multiple-dose studies, the incidence of tardive dyskinesia was 0.6 percent (9/1499 patients).
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) and Alkermes, Inc. developed Risperdal Consta to combine the advantages of long-acting delivery with the established benefits of oral risperidone. Oral Risperdal has been marketed in tablet form in the United States by Janssen Pharmaceutica Products, L.P., since 1994, and also is available in oral solution and quick dissolving tablet forms. Approved for marketing in more than 100 countries, Risperdal is the most widely prescribed atypical antipsychotic in the world.
Janssen Pharmaceutica Products, L.P., a wholly owned subsidiary of Johnson & Johnson, has a long track record in developing and marketing treatments for central nervous system disorders. Based in Titusville, N.J., its other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at http://www.janssen.com/.
A global leader in pharmaceutical R&D, J&JPRD and its affiliate companies are committed to bringing to market high-value, cost-effective products that treat disease and significantly improve the health and lifestyles of people worldwide. Research areas include psychiatry, gastroenterology, oncology, anti-infective, central nervous system, diabetes, hematology, immunology/inflammation and women's health. For more information, visit http://www.jnjpharmarnd.com/.
* Bradykinesia, extrapyramidal disorder and hypokinesia
(1)Arnoldussen, WJ. Direct Switch from Atypical Antipsychotics to
Risperidone Long-Acting Injectable. Presented at the 157th Annual
Meeting of the American Psychiatric Association, New York, NY, May 1-6,
2004
(2)Berry, SA. Patients Switched from Olanzapine to Long-Acting
Risperidone in Schizophrenia. Presented at the 157th Annual Meeting of
the American Psychiatric Association, New York, NY, May 1-6, 2004
(3)Lasser, RA. Long-Acting Risperidone in Stable Patients with
Schizophrenia Switched from Oral Treatment with Quetiapine. Presented
at the 157th Annual Meeting of the American Psychiatric Association,
New York, NY, May 1-6, 2004
Media
Melissa Katz
Janssen Pharmaceutica Products, L.P.
609-730-2612
mkatz2@gpcus.jnj.com
Matt Audette
Feinstein Kean Healthcare
413-585-8979
matthew.audette@fkhealth.com
Janssen Pharmaceutica Products, L.P.