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2018-01-18
New Real World Evidence Shows that Long-acting Antipsychotics Reduce Risk of Mortality for Patients Living with Schizophrenia Compared to Oral Antipsychotics

New Real World Evidence Shows that Long-acting Antipsychotics Reduce Risk of Mortality for Patients Living with Schizophrenia Compared to Oral Antipsychotics



BEERSE, Belgium, January 18, 2018 /PRNewswire/ --

The Janssen Pharmaceutical Companies of Johnson & Johnson announce results of new real world evidence from a study of almost 30,000 people, which supports the benefits of long-acting antipsychotics (LATs) in reducing the risk of mortality among patients with schizophrenia. LATs are associated with a 33% lower risk of mortality than corresponding oral antipsychotics (HR 0.67, 95% CI 0.56-0.80).[1]

These new findings published in Schizophrenia Research also show that the lowest mortality was observed for once-monthly paliperidone LAT (HR 0.11, 95% CI 0.03-0.43), oral aripiprazole (HR 0.22, CI 95% 0.15-0.34), and risperidone LAT (HR 0.31, CI  95% 0.23-0.43).[i] Additionally, mortality risk among patients with schizophrenia is 56% lower with antipsychotic treatment compared to no antipsychotic treatment (adjusted HR 0.44, 95% CI 0.39-0.49).[1]

"This study has important implications, as we can now understand the role of long-acting and oral antipsychotics in reducing risk of mortality for people living with schizophrenia in a real life setting," said lead author Professor Jari Tiihonen, Karolinska Institutet, Sweden. "People with schizophrenia can lose decades of their life, and this evidence demonstrates that wider use of antipsychotic treatment, particularly second generation LATs, can help protect the lives of patients."

This large real world study compares the effectiveness of antipsychotic treatments on mortality, psychiatric re-hospitalisation and treatment failure outcomes in patients with schizophrenia, from a Swedish nationwide cohort, using state-of-the-art methodology.

Data on the re-hospitalisation analysis, published in the JAMA Psychiatry in June 2017, showed that LATs and oral clozapine are substantially more effective than other antipsychotics in reducing the risk of re-hospitalisation compared to no antipsychotic. The study also showed that LATs result in a 22% risk reduction of re-hospitalisation compared to corresponding oral antipsychotics (HR 0.78, 95% CI 0.72-0.84).[2] In newly diagnosed patients, the use of LATs results in a 32% reduction in re-hospitalisation compared to the corresponding oral (HR 0.68, 95% CI 0.53-0.86), supporting the use of LATs earlier in the treatment of schizophrenia.[2]

"Reducing the risk of relapse and therefore re-hospitalisation among people living with schizophrenia is a key treatment goal," said Mikael Själin, Therapeutic Area Head CNS, Janssen-Cilag AB. "This evidence demonstrates that antipsychotics, and particularly LATs can help to keep patients out of hospital, ultimately giving people living with schizophrenia greater independence and an opportunity to focus on their future."

Janssen has a long heritage in neuroscience and is committed to improving the lives of people living with mental illness. Over 60 years ago, Janssen discovered one of the first treatments for schizophrenia, and continues to invest in expanding the treatment options and supporting the needs of those affected by serious mental illness.

About the study 

This large nationwide study uses state-of-the-art methodology, and was to Janssen's knowledge, one of the first to investigate the comparative effectiveness of antipsychotic treatments using within-individual analysis to overcome selection bias for the re-hospitalisation results. This method enables correction for selection biases, since each individual serves as his or her own control.

All individuals, aged 16-64, living in Sweden with a diagnosis of schizophrenia during July 1, 2006 and December 31, 2013 were included (prevalent cohort, N=29,823). The primary focus of this study is on patients with a diagnosis of schizophrenia. In clinical practice in Sweden, schizophrenia and schizoaffective diagnosis are often used interchangeably and would not generally impact on treatment decisions. Given the clinical reality of interchangeability, both diagnoses were included in the inclusion criteria.

The study was funded and sponsored by Janssen. The study team consisted of members from Karolinska Institutet and members of Janssen. Statistical analysis was provided by an independent third party, EPID Research, a Finnish scientific research organisation focused on real world evidence.

About schizophrenia
Schizophrenia is a complex and chronic brain disorder, in which symptoms can be severe and disabling and can affect all aspects of a person's daily life. It affects people from all countries, socio-economic groups and cultures. Its prevalence is similar around the world - almost one person in every 100 will develop schizophrenia before they reach the age of 60, with men slightly more at risk.[3],[4]

There is no single cause of schizophrenia. Different factors acting together are thought to contribute to the development of the illness. Both genetic and environmental factors seem to be important.[5] Symptoms of schizophrenia can include hallucinations, delusions, lack of emotional response, social withdrawal/depression, apathy and a lack of drive or initiative.[3]

Schizophrenia is typically a lifelong condition, but there are treatments that can be beneficial. Clinical guidelines recommend that the optimal treatment package is a combination of antipsychotic medication along with psychotherapy, psycho-education and self-help.[6] Effective treatment may allow people with the condition to enjoy a more fulfilling life, which may include returning to work or study, independent living and social relationships, which in turn can aid their recovery.[7]

About the Janssen Pharmaceutical Companies 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at http://www.janssen.com/emea. Follow us at http://www.twitter.com/janssenEMEA.

Janssen-Cilag International NV is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

References  Taipale H, Mittendorfer-Rutz E, Alexanderson K et al. Antipsychotics and mortality in a nationwide cohort of 29,823 patients with schizophrenia. Schizophr Res. 2017 December 20; doi: 10.1016/j.schres.2017.12.010. [Epub ahead of print]

Tiihonen J, Mittendorfer-Rutz E, Majak M et al. Real-world effectiveness of antipsychotic treatments in a nationwide cohort of 29,823 patients. JAMA Psychiatry 2017;74(7):686?693.

American Psychiatric Association (APA). Practice guideline for the treatment of patients with schizophrenia. Second edition 2004;42. Available at http://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia.pdf (last accessed January 2018).

Picchioni M, Murray R. Schizophrenia. BMJ 2007;335:91.

Lang U, Puls I, Muller DJ et al. Molecular mechanisms of schizophrenia. Cell Physiol Biochem 2007;20(6):687-702.

National Institute for Health and Clinical Excellence: Psychosis and schizophrenia in adults: prevention and management; National Clinical Practice Guidelines Number CG178. Available at https://www.nice.org.uk/guidance/cg178 (last accessed January 2018).

Fleischhacker WW, Arango C, Arteel P. et al. Time to commit to policy change. Sch Bull 2014;40:165-194.
i. Please refer to the manuscript for mortality rates for the other compounds included in the study




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