Personalized medicine in schizophrenia (PerMedSchiz)

Schizophrenia is a disabling mental illness that affects millions of Europeans. While antipsychotic medications alleviate symptoms in one third of patients, one third exhibit persistent symptoms and one third do not respond at all. There is an urgent unmet need to identify reliable predictors of outcome and treatment response to guide personalized treatment. There is suggestion that levels of immune-related molecules in the blood can predict relapse and response to treatment in schizophrenia patients and that a subset of patients with pro-inflammatory signs in their blood can benefit from add-on anti-inflammatory drugs. As part of this international collaborative project, a randomized clinical trial will be conducted with an objective to assess the clinical and cost- effectiveness of algorithm-based treatment stratification for schizophrenia in several European countries. The Department of Health Economics at the Medical University of Vienna (Principal Investigator: Prof. Judit Simon, Senior researcher: Assoc.-Prof. Susanne Mayer) leads the health economic research focusing on whether treatment stratification is cost-effective when compared to treatment as usual within the 6 months trial period and beyond using multi-national economic evaluation and modelling techniques. Results are expected to provide international evidence to the development of more effective and better optimized care for those with schizophrenia.

Health economic aspects of personalized schizophrenia treatment Schizophrenia is a complex and often lifelong mental illness affecting more than 23 million people worldwide. Although antipsychotic medications are widely used, many patients do not respond adequately and finding the right treatment often relies on trial and error. Recent research suggests that inflammation may be a contributing factor in some patients, potentially opening the door to more individualized treatment approaches. Our goal was to assess a newly developed blood test-based algorithm for people with schizophrenia to identify signs of inflammation resulting in a higher likelihood of no treatment response, side effects or relapse while on antipsychotic therapy and those patients who could benefit from additional anti-inflammatory treatment. We tested the impact of this more personalized schizophrenia treatment using celecoxib on symptoms, quality of life and costs up to 6 months in the TargetFlame clinical trial conducted in Germany. In our health economic study, we aimed to compare the quality of life and health and social care costs of patients with an 'inflammatory profile' to those without one, and also assessed the additional costs and benefits of a blood test-driven, add-on anti-inflammatory treatment. Overall, 32 patients with an inflammatory profile participated in the trial, some receiving celecoxib, some receiving placebo randomly. TargetFlame also screened and collected data from an additional 47 patients with a non-inflammatory profile. A total of 32 patients (inflamed profile: 15, non-inflamed profile: 17) participated in the health economic study. Our findings showed that patients with an inflammatory profile had significantly higher healthcare costs in the months before study entry than those without inflammation. This suggests that these patients have greater care needs in general and that effective targeted interventions indeed could be cost-effective. Modelling of the cost and quality of life impacts of targeted anti-inflammatory treatment is ongoing. By linking simple biological testing with treatment decisions and resulting healthcare data, our study is among the first ones that explored the real-world impact of precision anti-inflammatory treatment in schizophrenia. The findings highlight how future treatment strategies could be informed not only by symptoms, but also by objective biological measures, supporting smarter, more personalized, effective and potentially cost-effective care. These early health economics insights may help to inform future policy, practice and research aimed at improving care for people with schizophrenia once the main clinical results become available.