CONTRIBUTE

Switching from off-label & best supportive care to approved therapies for various autoimmune diseases: Implementation, impact on disease progression and adverse events

Project overview

In autoimmune diseases, the immune system mistakenly fights the body's own structures (tissue/organs). Around five to eight per cent of people in Germany suffer from this type of disease, which is very stressful for those affected. These include rare diseases such as myasthenia gravis and giant cell arteritis. In the past, these diseases were often treated with drugs that severely impair the immune system, have a potentially high risk of side effects or are authorised for other autoimmune diseases. In recent years, more and more specific therapies for these rare autoimmune diseases have been developed and approved. However, it is unclear to what extent these active substances are used and to what extent they improve the treatment results of those affected under everyday conditions.

Project objective

The CONTRIBUTE project team aims to close this knowledge gap and thus improve the supply of medicines to those affected in the long term. In particular, the aim is to gain insights into the characteristics of the patients treated and the efficacy and safety of the drugs used under routine conditions. The plan is to evaluate data from around 74 million people with statutory health insurance from 2009 to 2023 using data from the Research Data Centre (FDZ) located at the BfArM. In addition, possible influencing factors that are not mapped in the secondary data will be analysed. This will be made possible through qualitative interviews with around 30 patients and 15 healthcare providers on their experiences and challenges with the novel drugs. The findings will be compared with the therapy goals and the impact on therapy costs for the healthcare system. The project is being funded for two and a half years with a total of around 1.26 million euros.

Outlook

The results of this project should help to develop strategies for better care for those affected and, for example, to reduce the risks associated with the use of novel drugs. In addition, the overview of the costs and benefits of the various drugs will allow a more realistic assessment of the economic framework conditions.

Logo mit Schriftzug CONTRIBUTE

Further information

  • Duration: 04/2024 - 09/2026
  • Funding: Federal Joint Committee, Innovation Committee at the Federal Joint Committee (funding reference: 01VSF23041)
  • Responsible: Chair of Clinical Pharmacology
  • Participation: The study integrates the patients' perspective in every phase of the project. To this end, the project is supported by the German Rheumatism League Federal Association and the German Myasthenia Society (DMG) as research partners.
  • Consortium leadership/ Project management: Prof Dr Sven Schmiedl, Witten/Herdecke University, Chair of Clinical Pharmacology
  • Consortium partners (with funding):

    - Prof Dr Nina Timmesfeld, Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum (RUB)

    - Ingo Meyer, PMV research group, University Hospital Cologne

    - Prof Dr Stephanie Stock, Institute for Health Care Economics and Clinical Epidemiology, University Hospital Cologne

    - PD Dr Ute Karbach, Institute for Medical Sociology, Health Care Research and Rehabilitation Science, University of Cologne

    - PD Dr Uta Kiltz, Rheumatology Centre Ruhr Area, Ruhr University Bochum (RUB)

    - Prof Dr Kerstin Hellwig, Catholic Hospital Bochum, Ruhr University Bochum (RUB)

Contact us