By looking into the disease mechanisms of psoriatic arthritis an international team of 26 research partners, pharmaceutical companies, SMEs and patient organisations, led by University College Dublin (UCD), are collaborating in HIPPOCRATES a new €21 million research project which aims to improve diagnostic and therapeutic options for patients living with psoriatic arthritis.
By gaining a better understanding of the complex interplay between clinical and environmental factors, genotype and molecular pathways, the HIPPOCRATES team aims to enable earlier diagnosis and a more accurate prediction of disease progression. This will revolutionise treatment and deliver profound patient benefits.
The 5-year project, launched today, has been funded by the Innovative Medicines Initiative (IMI 2), a Joint Undertaking (JU) of the European Union (EU) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Of the total budget, 50% is being contributed by the EFPIA partners (Novartis [EFPIA lead], UCB [EFPIA Co-lead], Pfizer and BMS) and 50% by the EU.
Psoriatic arthritis (PsA) is a chronic immune-mediated inflammatory disease that affects joints and other components of the musculoskeletal system, together with skin involvement, in an estimated 5-10 million individuals in the EU.
The symptoms of the disease, including pain, joint stiffness and fatigue, can impact on many aspects of life including function and productivity. Overall, it is increasingly recognised that PsA is associated with multiple comorbidities, particularly those affecting mental health such as depression and those which promote the development of accelerated atherosclerosis and contribute to the observed increase in cardiovascular morbidity and mortality.
PsA most commonly develops on a background of established skin and/or nail psoriasis, however it can be difficult to diagnose as there are no diagnostic criteria or laboratory tests available. This can contribute to diagnostic delay and poor outcomes. PsA is characterised by considerable heterogeneity with regards to clinical features, disease progression and response to targeted therapies.
Future treatments will need to focus on earlier disease stages and be selected on the basis of detailed patient molecular profiling so as to limit poor long-term outcomes and possibly prevent the development of PsA altogether.
“We anticipate that the advances provided by HIPPOCRATES will result in significant new developments that improve patients’ quality of life,” said Professor Oliver FitzGerald, Newman Clinical Research Professor, UCD School of Medicine and the UCD Conway Institute of Biomedical and Biomolecular Research, and co-ordinator of the HIPPOCRATES consortium.
Atturos, a UCD clinical diagnostics spin-out company supported by NovaUCD, is among the HIPPOCRATES SME consortium partners. The company is focused on integrating molecular diagnostics into decision making tools to improve the health and quality of life of patients while also increasing the cost-effectiveness of healthcare systems.
Joint co-coordinator, Professor Stephen Pennington, Professor of Proteomics at the UCD School of Medicine and the UCD Conway Institute of Biomedical and Biomolecular Research and founder, Atturos said, “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.”
“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,” added Dr Christine Huppertz, Senior Principal Scientist in the Disease Area Autoimmunity, Transplantation and Inflammation at Novartis, and EFPIA lead of the consortium.
“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 Partner’s within all aspects of the project,” added Denis O’Sullivan, Patient Representative Arm of GRAPPA-EU.
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 Europe-wide library of relevant clinical biosamples.
HIPPOCRATES will also establish a large, prospective, observational study of 25,000 patients with psoriasis who will be recruited and followed on-line for development of PsA, with patient-centric blood sampling at defined intervals.
Furthermore, the team of experts will evaluate and validate newly discovered biomarker signatures for the early diagnosis of PsA, for the identification of psoriasis patients at risk of developing PsA, for the identification of PsA patients at highest risk of damage progression and for personalised or stratified treatment strategies so as to maximise treatment response.
Overall, HIPPOCRATES places particular emphasis on the involvement of patients, clinicians, primary care practitioners, regulators, SMEs (Oxford Biodynamics Limited and NEOTERYX Limited in addition to Atturos Limited) and relevant large industry to meet the needs of all stakeholders and to maximise the project’s impact.
Formed as a transdisciplinary consortium, the project team comprises 26 partner institutions from Belgium, Denmark, Germany, Ireland, Italy, Spain, Sweden, Switzerland, the Netherlands, the United Kingdom and the United States of America. 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.