Antibody based therapeutics (biologics) have revolutionized treatment of a wide range of diseases. One of the most successful therapeutic areas in medicine includes immune-mediated inflammatory diseases such as rheumatic diseases, skin disorders, and intestinal pathology. However, the high costs of these drugs and the need for continuous use in most of these diseases represents a major challenge for all health care systems worldwide.
Spondyloarthritis (SpA) is a form of chronic arthritis. It typically affects a young population in their early thirties, the time when most people start a family and develop their professional career. The overall prevalence of SpA is estimated to be around 1% of the population and taking this into account the estimated expenditure for TNF biologics for this indication is at least 40 million euro annually. It was shown that response to treatment was markedly higher in early forms of disease with high rates of clinical remission. This suggests there could also be a ‘window of opportunity’ for drug-free remission. Our hypothesis is that first line use of biologics will elicit a better response. We have tested this in a proof of concept (POC) study, in which 82% of all included patients experienced a complete resolution of symptoms after which treatment could be discontinued. Intriguingly, over 50% of patients were staying in drug-free remission.
This inspired us to establish the SPARTACUS trial, which aims to pave the path to use a precision medicine approach to delineate the patient population that may benefit from such an early intervention approach, define the precise time window amenable to inducing drug-free remission and establish now biomarkers predicting drug-free clinical response across Flanders. SPARTACUS will be the first worldwide trial to compare efficacies and overall costs of standard of care treatment with initial TNF inhibition in early spondyloarthritis.
The project consortium focuses on:
- Investigating the possible superiority of early treatment of psoriatic SpA patients with biologic treatment as compared to standard of care.
- Delineating the window of opportunity for pSpA: a transient time frame in which a disease is more susceptible to treatment.
- Unraveling new biomarkers of therapy response using cutting-edge single cell technology and epigenetic profiling.
- Determining health-economic and societal impact of earlier and more biologic intensive treatment of patients with recent onset pSpA.
- Increasing awareness among referring physicians and patient-advocacy groups about the value of early recognition and treatment in rheumatology.
SPARTACUS will also explore the societal and economic impact of this new, temporally restricted biologics treatment and improved diagnosis.
Facts & Figures
Precision medicine will be improved by translating innovative molecular diagnostic paradigms into clinical practice
Precision medicine will be improved by translating new insights in molecular mechanisms of disease into clinical practice
KU Leuven-UZ Leuven
UZ Gent • Maria Middelares • ASZ Aalst • AZ Sint-Jan Brugge • AZ Sint-Lucas Brugge • ZNA Antwerpen • Sint-Augustinus Antwerpen • UZ Leuven • Reuma Instituut Hasselt
Contribution to the project
Dirk Elewaut and Martin Guilliams (VIB-UGent Center for Inflammation Research) deliver their expert knowledge on molecular immunology and inflammation, as well as access to the Single Cell Platform. Rik Lories and Frederik De Smet (KU Leuven Lab of Tissue Homeostasis and Disease) bring their expertise on epigenetics and CyTOF, while Annelies Boonen (Maastricht UMC, NL) will perform the health economic evaluation and budget impact analysis. Finally, the Department of Rheumatology at UZGent will be involved, as will the Be-GIANT Consortium (Gent university hospital, Maria Middelares-Gent, ASZ Aalst, AZ Sint-Jan Brugge, AZ Sint-Lucas Brugge, ZNA-Antwerpen, Sint-Augustinus Antwerpen, Leuven university hospital, Reuma Instituut Hasselt), which was set up to create a unique cohort of newly diagnosed SpA patients (currently 400 patients and counting).
The objective of the VIB-GC program is to significantly increase the societal impact of VIB, hence taking its scientific leadership to the next level of global visibility, strategies between partners towards sharing of capabilities (samples, data, infrastructure) are prerequisite and motivated within the VIB GCP, aligned with the general principles of RRI and the Open Science policy of VIB in particular.
SPARTACUS will determine the health-economic and societal impact of earlier and more biologic intensive treatment through the use of 2 years’ worth of actual patient data and a model-based lifelong incremental cost-utility analysis from a healthcare and a societal perspective. The researchers will also work to increase awareness about the value of early recognition and treatment in rheumatology among referring physicians and patient advocacy groups. These results will be used in direct negotiations with health authorities in Belgium to change current reimbursement criteria for SpA therapy.
Dirk Elewaut: " We are thrilled with having Spartacus approved as a VIB Grand Challenges project. Spartacus has the ambition to revolutionize the outcome of patients suffering from early peripheral spondyloarthritis (one of the most common forms of chronic arthritis) by reverting a chronic disease demanding lifelong medication into a temporary one by inducing drug free remission through early but temporary treatment with biologics. By coupling a randomized clinical trial with high end molecular profiling in synovial tissue we additionally aim to develop tools facilitating prediction of patients that could benefit from such a strategy. Importantly, Spartacus will also assess the health economic benefit of such an early intervention strategy”.