PRECISEADS is a European collaborative project within the Innovative Medicines Initiative (IMI) participated with 23 research centers and five companies from 12 European countries that started on February this year and will work for 5 years with a budget of €22.7 million, with the ultimate goal of finding innovative diagnostic technology to relate systemic autoimmune disease (SAD) to detectable changes in individual molecular signatures
Inflammatory autoimmune diseases such as rheumatoid arthritis and lupus affect 1-3% of the population, and while treatments exist, these are costly and have a number of serious side effects. There is growing evidence that many of these conditions may be incorrectly classified. The PRECISESADS project will study 2 500 people with various autoimmune diseases, gathering data on the molecular causes of their disease as well as their clinical symptoms. Using this information, they will pave the way for a new classification of these diseases, something that will allow doctors to offer patients more personalized treatments at an earlier stage of their disease. Chronic inflammatory autoimmune disorders like systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) are found in 1-3% of the general population.
They are particularly prevalent in women, with SLE affecting nine times more women than men. Symptoms of these diseases can be severe, and patients need regular check-ups. For example, symptoms of lupus include painful, swollen joints, fever, rashes, fatigue, and sensitivity to the sun. There are few treatments available for these diseases; most receive steroids, which are associated with serious side effects including an increased propensity to infections, osteoporosis, and cardiovascular disease.
In addition, these diseases are difficult to diagnose early enough in the disease process to prevent severe or even fatal outcomes. In some cases, it can take – six to eight years from the onset of symptoms to arrive at a diagnosis. This can also have a significant impact on the psychological well-being of the patient.
New and promising biological treatments are being developed for SLE, but it is not always clear which lupus patients will benefit from which treatment, plus separate disease classification means that they cannot be used to treat other autoimmune diseases which researchers believe share a similar molecular basis. In fact, the pharmaceutical companies face major problems in trying to identify tests to determine the usefulness of drugs in clinical trials.
A new classification of inflammatory diseases
By establishing a Europe-wide, large-scale team, PRECISESADS will provide new data to offer a more appropriate classification of these patients. The project will analyse in great detail blood and urine samples of 2 500 people with a range of systemic autoimmune diseases, as well as patients with suspected autoimmune disease who don’t have a diagnosis because they do not fulfill current clinical criteria for any of the systemic autoimmune diseases. Through the analysis of these patients’ data, the project hopes to be able to define clusters of individuals who share similar molecular pathways for their disease and so could be treated in a targeted and personalized way. By evaluating the molecular and clinical data using the latest technology, the project will deliver new biomarkers for use in more targeted clinical trials. Clinicians can then tailor therapies according to the specific molecular pathways found in individual cases. In short, treatments will become more personalized.
Towards targeted treatments
A personalized approach to the treatment of autoimmune diseases would allow patients to receive an earlier and more accurate diagnosis. Since the new data will reveal the molecular mechanisms specific different groups of diseases, a tailored approach to clinical therapy can be identified and the precise molecular pathway can then be targeted. What’s more, earlier detection and more effective treatments will mean that the damaging effects of a late diagnosis can be avoided, and the patient’s disease progression can be better controlled.
Sharing data to move forward
PRECISESADS brings together industry experience with academic and clinical expertise in the fields of genetics, metabolomics, mass spectrometry, rheumatology, and autoimmunology. The project will provide an advantage for the European pharmaceutical industry through the unique possibility of sharing new and existing data and findings on an unprecedented scale for these diseases. The expertise of the pharmaceutical industry is essential, as they have important knowledge of prior failures in this disease area and understand the urgent need to overcome the problem of the inappropriate classification of patients.
By pooling existing data and using cutting-edge technologies, the project will help to pave the way for more effective and earlier treatment of these debilitating and dangerous autoimmune diseases. The research being undertaken has always been seen as necessary but sufficient funding and a collaborative model has only now become possible through IMI. This is a unique research project will directly benefit from advances in technology and will ultimately deliver results at the patient’s bedside.