Presenter of 2 Presentations
IS001 - A EUROPEAN REGISTRY IN AUTOIMMUNITY (ID 779)
Abstract
Abstract Body
Registries are an important component for the acquisition of information in medicine. They complement clinical trials that are relevant for approval, above all by collecting real word data, which is important not only for the frequent comorbidities that often lead to exclusion in clinical trials, but also for collecting long-term data on safety and also on the efficacy of old and new substances. In addition to national registries, which provide important information on the health status of entire countries and their medical care, there is above all an unmanageable number of disease- or medication-related registries, especially for rare and complex diseases. The European Reference Network ReConnet has just conducted a comprehensive survey to get an overview of the available data.
These registers, which are mostly country-based, are as heterogeneous as the diseases they aim to record. Most of these registries are start-up financed, their sustainability depends mostly on the initiative of individual scientists or national professional societies, a few are established Europe-wide. In addition, most registries are set up in such a way that they are not fed from data already collected, but require additional input without this being remunerated. In addition, their evaluation is not carried out in a timely manner and relates to an e.g. annual collection of information that can only incompletely depict the care provided.
With the increasing possibilities of information technology, these and other limitations of current registers can be completely eliminated. We will give an example of how routine care, basic science and support for clinical trials can be integrated in a Medical Data Space in such a way that all areas benefit maximally. We are currently developing such a data space under the name CHRONIN as a model for SLE in Europe.
IS009 - TREAT-TO-TARGET (T2T) IN SLE (ID 806)
Abstract
Abstract Body
The prognosis of SLE has improved significantly in recent decades. This is mainly due to better diagnostics and more consistent use of known immunosuppressive substances. In addition, more and more mild cases are being detected. However, we are still a long way from personalised medicine for those affected. On the one hand, this is due to the lack of suitable biomarkers that reliably identify the pathophysiological processes; on the other hand, we also still lack specific interventions for the various pathophysiological targets in SLE. Together with the heterogeneity of the disease expression, this all contributes to less successful studies.
One way to circumvent this complexity is T2T, standardising the target and, through response, recognising the differences between individual sufferers. The definition of remission and low disease activity in SLEs sets the stage for a T2T approach in SLE. Analyses of different cohorts from all regions of the world have shown that a state of remission is associated with less damage acquisition, better quality of life and less pain. This finding can be well explained by a selection of milder disease cases. So far, it has not been shown for SLE, in contrast to rheumatoid arthritis, that intensified treatment to achieve remission leads to comparable results. Most importantly, compared with definitions of remission in other diseases, SLE also involves limiting therapy - prednisolone ≤ 5mg/d.
We have developed two study designs to evaluate the T2T concept in SLE.