New data demonstrate that risperidone long-acting injection extends time to relapse in patients with schizophrenia compared to those treated with oral quetiapine

HIGH WYCOMBE, England, 6 May 2008 – A new study, presented for the first time today at an international psychiatric meeting, examined the time to relapse in patients with schizophrenia treated with risperidone long-acting injection (RLAI) or oral quetiapine. The data show that the mean time free from relapse for patients treated with RLAI was statistically longer than those treated with quetiapine (607 days RLAI versus 533 days with quetiapine, p<0.0001). 

For patients living with schizophrenia, relapse is associated with an increased risk of hospitalisation and a major negative impact on their quality of life.  Non-compliance or partial compliance remain key barriers in the management of schizophrenia and are often significant contributing factors in relapse.2  Patients experiencing numerous relapses are at high risk of never regaining previous levels of functioning,   therefore, preventing relapse is paramount in order to improve the long-term outcome for people living with the condition.
 
This 24-month, open-label, active-controlled, comparative study, randomised 710 patients to receive RLAI (N=355 [mean dose 32.75 mg]) and oral quetiapine (N=355 [mean dose 396.75 mg]).  The study investigated the effect of treatment with RLAI or oral quetiapine on relapse prevention and efficacy maintenance as measured by time to relapse.  The data indicate that not only did RLAI significantly extend time to relapse versus quetiapine (607 days RLAI versus 533 days with quetiapine, p<0.0001), fewer patients in the RLAI treatment arm relapsed over the 24-month trial period compared with oral quetiapine (16.5% and 31.3% respectively). In addition, the treatment completion rates favoured RLAI (51.7%) over oral quetiapine (38%) [p <0.0004].1

Safety results demonstrated that RLAI had a good safety and tolerability profile, with both treatments being comparable.  67.5% of patients experienced a treatment-emergent adverse event (TEAE) when treated with RLAI, compared with 68.5% of patients in the oral quetiapine arm.  Extrapyramidal symptom (EPS) related TEAEs were observed in 10% of the subjects in the RLAI arm and in 6% of the subjects in the quetiapine arm. Weight gain was observed in both treatment arms with no statistically significant differences in changes in body weight or BMI versus baseline (7% weight gain for RLAI versus 6.2% for quetiapine).  Somnolence was reported in 1.8% of patients treated with RLAI compared to 11.3% with quetiapine. Potentially prolactin-related TEAEs were observed in 16.7% of the patients in the RLAI arm and in 3% of patients in the quetiapine arm.  Reasons for withdrawing from the study, other than relapse, were equivalent in both treatment groups.1

- ENDS-
Notes to Editors:
In this study, a small number of patients (N=46) were randomised to aripiprazole for exploratory purposes only. The descriptive efficacy and safety analysis of these patients will be presented separately.

Standard Relapse Criteria used for this study:
Relapse diagnosed if subjects met any of the following criteria on 2 consecutive evaluations conducted 3-5 days apart:
• Psychiatric hospitalisation
• Increase in level of care necessary and > 25% increase in PANSS total score from baseline or an increase of 10 points if the baseline score was < 40
• Significant clinical deterioration defined as a CGI-C score of 6 (much worse)
• Deliberate self-injury
• Emergence of clinically significant suicidal or homicidal ideation
• Violent behaviour resulting in significant injury to another person
• Exceeding the registered dose of the drug

About Schizophrenia
An estimated one percent of the world’s population suffers from schizophrenia – 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 immediately obvious.

About Risperidone Long-Acting Injection
Risperidone long-acting injection was first approved in the UK in August 2002, and is now approved in more than 70 countries worldwide. In the UK, it is indicated for use in adults with schizophrenic psychoses and other psychotic conditions in which positive and/or negative symptoms are prominent. Risperdal Consta has not been studied in children and adolescents younger than 18 years of age.

Risperidone long-acting injection uses Alkermes proprietary Medisorb® technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia.

About Janssen-Cilag
Janssen-Cilag has dedicated over 50 years of research and development to improving the lives of those who live with severe mental illness and continues to invest in this area. Janssen-Cilag has a long track record in developing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. Products include Concerta® XL (ADHD), Durogesic® DTrans® (pain management), Eprex® (anemia), Topamax® (epilepsy, migraine prevention), Risperdal® (schizophrenia, bipolar disorder), Risperdal® Consta® (schizophrenia) and Velcade® (progressive multiple myeloma).

More information can be found at www.janssen-cilag.co.uk

 # #
References

1.           Medori R, Wapenaar R, de Arce R et al.  Relapse Prevention and Effectiveness in Schizophrenia with Risperidone Long-Acting Injectable (RLAI) Versus Quetiapine. Poster presented at 161st Annual American Psychiatric Association Meeting, 2008, Washington, USA

2.            Narasimhan M, Pae CU, Masand N & Masand P.  Partial compliance with antipsychotics and its impact on patient outcomes. Intl Jrnl of Psych in               Clinical Practice 2007;11(2):102-111

[1]                Birchwood M, Toddd P, Jackson C. Early intervention in psychosis. The critical period  hypothesis. Br J Psychiatry Suppl 1998; 172:53-59

Posted: May 2008

Comments