Eleven Patient Research Partners (PRPs) from three organizations (EULAR, GRAPPA-EU, and EUROPSO) participate in the new research project HIPPOCRATES, ensuring the patients' perspective is preserved and prioritized in all research activities to maximize the project's impact.
Patient involvement is integrated through four different routes: 1) PRPs are involved in every phase of the project, contributing to research design, protocol development, ethical procedures, recruitment strategies, outcome selection, interpretation and dissemination of study findings, 2) the 11 participating PRPs form the Patient Advisory Council which will monitor the overall research progress and advise the consortium on whether the involvement of patients in the project is adequate and effective, 3) EULAR is the co-leader on communication and dissemination activities, especially those targeting patients, patient organizations and the general public, 4) two additional PRPs are members of the project's External Advisory Board (EAB). By demonstrating the pervasive benefit of the patient voice throughout the project, HIPPOCRATES will be an example to future projects in RMD and health research.
EULAR has longstanding experience in training and supporting PRPs and researchers and in managing patient-researcher collaboration. Its network of 69 trained PRPs have engaged in research projects for over a decade.
By looking into the disease mechanisms of psoriatic arthritis (PsA), the new research project HIPPOCRATES aims to improve diagnosis and treatment for people living with this condition. By gaining a better understanding of the complex clinical, environmental and genetic pathways involved, the team hopes to enable earlier diagnosis and more accurate prediction of disease progression. This will revolutionize treatment and deliver profound benefits for people with PsA. The project will run for 5 years, with a budget of €21 million provided by the Innovative Medicines Initiative (IMI2) - a joint undertaking of the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Of the total budget, 50% is contributed by Novartis, UCB, Pfizer and BMS, and 50% by the EU.
PsA is a chronic immune-mediated inflammatory disease that affects the joints, musculoskeletal system, and skin. It affects an estimated 5-10 million people in the EU. Symptoms include pain, joint stiffness, and fatigue - and it can impact many aspects of a person's life. It is increasingly recognized that PsA is associated with multiple comorbidities, particularly depression and accelerated atherosclerosis, which contributes to increased cardiovascular morbidity and mortality. PsA most commonly develops in people who already have skin and/or nail psoriasis. However, it can be difficult to diagnose as there are no specific criteria or laboratory tests available. This can lead to diagnostic delay and poor outcomes. The clinical features, disease progression and response to targeted therapies can be very variable in different people. Future treatments will need to focus on earlier disease stages and be selected based on detailed molecular profiling. It is hoped this will limit poor long-term outcomes and possibly prevent the development of PsA altogether.
"PsA is a complex Rheumatic and Musculoskeletal Disease (RMD) that affects people of all ages. The involvement of many other organs in addition to the musculoskeletal system contributes to increasing the disease burden for those afflicted. The developments of the HIPPOCRATES project will result in improved quality of life and increased participation in work by people with PsA. The project is of particular importance also because it is based on a broad collaboration between multiple stakeholders working all together for the benefit of PsA patients." said Professor Annamaria Iagnocco, EULAR President.
This was echoed by the Ireland coordinator of the HIPPOCRATES consortium, Professor Oliver FitzGerald, Newman Clinical Research Professor at University College Dublin, Conway Institute for Biomedical and Biomolecular Research, who said "We anticipate that the advances provided by HIPPOCRATES will result in significant new developments that improve patients' quality of life". Co-coordinator, Professor Stephen Pennington, Professor of Proteomics at University College Dublin and also in the Conway Institute added "The advances will include the identification of sub-populations and endotypes, the validation of existing and identification of new biomarkers, improved imaging options and the development of a sustainable infrastructure for future PsA research."
In order to achieve its goals, the HIPPOCRATES project will set up a single integrated database combining the cohorts and datasets of the most important European PsA studies, and establish a library of clinical biosamples. HIPPOCRATES will also establish a large, prospective, observational study of 25,000 people with psoriasis who will be recruited and followed online for development of PsA, with blood sampling at defined intervals. Furthermore, the team of experts will evaluate and validate newly discovered biomarker signatures that could be used for 1) the early diagnosis of PsA, 2) for identifying people with psoriasis at risk of developing PsA, 3) for identifying people with PsA at highest risk of damage progression, and 4) for personalized strategies to maximize treatment response.
Overall, HIPPOCRATES places particular emphasis on the involvement of patients, clinicians, primary-care practitioners, regulators, small and medium enterprises (SME; ATTUROS Limited, Oxford Biodynamics Limited and NEOTERYX Limited) and relevant large industry to meet the needs of all stakeholders and to maximize the project's impact. Alongside EULAR, the project team comprises 25 partner institutions from Belgium, Denmark, Germany, Ireland, Italy, Spain, Sweden, Switzerland, the Netherlands, the United Kingdom, and the United States of America. Led by University College Dublin, the partners contribute a diverse range of backgrounds including clinical, scientific, data analytics, ethics, patient participation as well as SME and pharmaceutical industry expertise in pursuit of the ambitious goals set for the HIPPPOCRATES project.
"HIPPOCRATES offers the great promise of powerful new tools to advance both early diagnosis and treatment of patients with PsA. Additionally, and to further its effectiveness, HIPPOCRATES retains the focus on the patient, involving Patient Research Partners within all aspects of the project" added Denis O'Sullivan, from the Patient Representative Arm of GRAPPA-EU.
Dr Christine Huppertz, Senior Principal Scientist in the Disease Area Autoimmunity, Transplantation and Inflammation at Novartis, and EFPIA lead of the consortium, said "This public-private partnership is a great opportunity to decipher this highly heterogenous disease, and to enable the development of novel PsA therapies and treatment strategies including precision medicine approaches".
The first IMI2 project on PsA officially starts on 1st July 2021, and the virtual kick-off meetings took place on the afternoons of the 12th and 17th May 2021.