Risperdal(R) Consta(R) Associated With Lower Risk of Hospitalisation Compared to Treatment With Other Antipsychotics in Patients With Schizophrenia

BEERSE, Belgium, March 25, 2011 - New data from an independent prospective study presented last week at the
19th European Congress of Psychiatry (EPA 2011) shows treatment with
Risperdal(R) Consta(R) (risperidone long-acting injection (RLAI)) is
associated with a lower risk of hospitalisation in patients with
schizophrenia compared to treatment with other antipsychotics over a 12-month
period. The data was collected as part of the French Cohort for the General
Study of Schizophrenia (CGS), which aimed to assess the impact of long-acting
injectable antipsychotic drugs compared to other antipsychotic drugs on the
risk of hospitalisation in real-life settings.

Schizophrenia is relatively common and the prevalence is similar around
the world. The lifetime risk for schizophrenia is estimated to be one person
in 100, and appears to be the same for men and women up to age 60 years.[1]
It is a devastating mental illness for both the patients and their families
and friends, as it seriously impairs a person's ability to think clearly,
relate to others and to function properly in society. While there is no cure,
many people with the illness respond well to antipsychotic medicines, the
mainstay of treatment for schizophrenia.

However, further relapses can have a terrible effect on the lives of
patients with schizophrenia and their families. Frequent relapses and
hospitalisation can increase the person's isolation and make it even more
difficult for them to find and keep a job.[2],[3],[4],[5],[6] Prevention of
future relapses is a crucial goal of therapy and patients who stay on
continual treatment are more likely to achieve optimal outcomes.[7],[8]

From a public health perspective, the estimated overall cost burden of
schizophrenia is also significant. For direct costs alone (e.g. general
practitioner and specialist consultations, hospital admissions and drug
treatment), the total estimated cost of schizophrenia in Europe is
approximately EUR33billion.[9],[10]

Results from 1,859 patients with schizophrenia who were followed up over
a 12-month period as part of the CGS, showed Risperdal(R) Consta(R)
significantly reduced the risk of hospitalisation by 34% compared to any
other antipsychotic treatments (adjusted relative rate (AAR), 0.66). In
addition, Risperdal(R) Consta(R) reduced the risk of hospitalisation by 47%
compared with other long-acting first generation antipsychotics (AAR 0.53).

"These results provide us with important additional data to better
understand the role that treatments like Risperdal(R) Consta(R) can play in
helping to reduce the overall burden of schizophrenia," said Professor Lucien
Abenhaim, LA-SER Group and Department of Epidemiology, London School of
Hygiene and Tropical Medicine.* "The Cohort for the General Study of
Schizophrenia results complement the data gained from blinded clinical
trials, and help to build a more accurate picture of treatment outcomes in
real-life."

Patients with schizophrenia who are non-adherent to medication are almost
five times more likely to relapse than those patients who are adherent,
significantly increasing the likelihood of relapse and hospitalisation,[12],
[13] which in turn increases the overall cost of care. Frequent relapses
and hospitalisation can increase a person's isolation and make it even more
difficult for them to find and keep a job.[14],[15],[16],[17],[18]

"Regular periods of hospitalisation following an acute episode is
extremely damaging for patients with schizophrenia and their families and
friends," said Dr Lupe Martinez, Medical Affairs Director, Janssen EMEA.**
"Not only does it place a significant strain on families, but it can damage
friendships and make it extremely difficult for someone with schizophrenia to
be self-sufficient and stay in employment. This data supports the important
role of antipsychotic medication to help keep a person's symptoms under
control and keep their lives stabilised."

Risperdal(R) Consta(R) was the first long-acting injectable
second-generation antipsychotic to be licensed for the maintenance treatment
of schizophrenia in patients currently stabilised with oral antipsychotics.
It has been shown to reduce the risk of relapse and re-hospitalisation[19]
and is associated with a reduction in overall treatment costs per patient
compared to other antipsychotics.[20] Reducing the rate of hospitalisation in
patients with schizophrenia is a key public health priority, given the
significant burden of this illness on healthcare systems, patients and their
family and friends.

About Risperdal(R) Consta(R) (Risperidone long-acting injection (RLAI))

Risperidone long-acting injection (RLAI) was the first long-acting
injectable of an atypical antipsychotic medication. It combines the
favourable efficacy and tolerability profile of an atypical antipsychotic
with the benefits of a long-acting formulation. RLAI only needs to be given
every two weeks, so patients do not have to worry about remembering to take
their medication every day, improving adherence and reducing the risk of
relapse.[12],[13] Further information about Risperdal(R) Consta(R) can be
found at:
www.medicines.org.uk/emc/medicine/9939/SPC/Risperdal+Consta+25+mg,+37.5+mg,+50+mg./

(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)

About Schizophrenia

Schizophrenia is a chronic, severe and disabling brain disorder that
seriously impairs a person's ability to think clearly, relate to others and
to function productively in society. The consequences of the disorder include
difficulties in thought processes leading to hallucinations, delusions,
disordered thinking and unusual speech or behaviour.

About Janssen EMEA

Janssen EMEA is one of the Janssen Pharmaceutical Companies, which are
dedicated to addressing and solving the most important unmet medical needs of
our time, including oncology (e.g. multiple myeloma and prostate cancer),
immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and
pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and
cardiovascular and metabolic diseases (e.g. diabetes). Driven by our
commitment to patients, we develop sustainable, integrated healthcare
solutions by working side-by-side with healthcare stakeholders, based on
partnerships of trust and transparency. More information can be found at
www.janssen-emea.com

Notes

* Professor Lucien Abenhaim is employed by LA-SER. The CGS study was
sponsored by an unrestricted grant from Janssen to the members of LA-SER.

** Dr Lupe Martinez is a full time employee of Janssen, EMEA.

References

———————————

[1] Lehman A et al. Practice guideline for the treatment of patients with
schizophrenia, second edition. Am J Psychiatry. 2004;161(2 Suppl):1-56

[2] Thornicroft G, Brohan E, Rose D, et al for the INDIGO Study Group.
Lancet. 2009;373(9661):408-15.

[3] Marwaha S, Johnson S, Bebbington P, et al. Br J Psychiatry.
2007;191:30-7.

[4] Marwaha S, Johnson S. Soc Psychiatry Psychiatr Epidemiol.
2004;39(5):337-49.

[5] Nithsdale V, Davies J, Croucher P. J Occup Rehabil. 2008;18(2
):175-82.

[6] Rosenheck R, Leslie D, Keefe R, et al; CATIE Study Investigators
Group. Am J Psychiatry. 2006;163(3):411-417.

[7] Masand PS, Roca M, Turner MS et al. Partial adherence to
antipsychotic medication impacts course of illness in patients with
schizophrenia: a review. Prim Care Companion J Clin Psychiatry.
2009;11(4):147-54.

[8] Peuskens J, Olivares JM, Pecenak J et al. Treatment retention with
risperidone long-acting injection: 24-month results from the Electronic
Schizophrenia Treatment Adherence Registry (e-STAR) in six countries. Curr
Med Res Opin 2010; 26:501-509

[9] Knapp M, Chisholm D, Leese M, Amaddeo F, Tansella M, et al. (2002)
Comparing patterns and costs of schizophrenia care in five European
countries: the EPSILON study. European Psychiatric Services: Inputs Linked to
Outcome Domains and Needs. Acta Psychiatr Scand 105, 42-54

[10] Andlin-Sobocki P, Rossler W (2005) Cost of psychotic disorders in
Europe. Eur J Neurol 12, Suppl 1: 74-77

[11] Kane, J. M. CNS Spectrums. 2007: 12 (10 Suppl 17), 21-26.

[12] Gaebel W et al. Relapse prevention in schizophrenia and
schizoaffective disorder with risperidone long acting injectable versus
quetiapine: Results of a longterm, openlabel, randomized clinical trial.
Neuropsychopharmacology 2010 Nov;35(12):2367-77. Epub 2010 Aug 4.

[13] Olivares et al. Eur Psychiatry. 2009; 24(5): 287-296

[14] Thornicroft G, Brohan E, Rose D, et al for the INDIGO Study Group.
Lancet. 2009;373(9661):408-15.

[15] Marwaha S, Johnson S, Bebbington P, et al. Br J Psychiatry.
2007;191:30-7.

[16] Marwaha S, Johnson S. Soc Psychiatry Psychiatr Epidemiol.
2004;39(5):337-49.

[17] Nithsdale V, Davies J, Croucher P. J Occup Rehabil. 2008;18(2
):175-82.

[18] Rosenheck R, Leslie D, Keefe R, et al; CATIE Study Investigators
Group. Am J Psychiatry. 2006;163(3):411-417.

[19] Leal et al. Pharmacoepidemiol Drug Saf 2004; 13:811-816.

[20] Spill B et al. Int J Psychiatr Clin Pract 2009; Early Online 1-10.

For Medical media only: For further information please contact: Sue Silk, Janssen EMEA, Tel: +44-1494-553955, Email: ssilk at its.jnj.com; Joanna Smith, Resolute Communications, Tel: +44-207-357-8187, Email: joanna.smith at resolutecommunications.com