Reduction of socio-economic burden

Currently, different scores are available to measure disease activity in each immune-mediated inflammatory disease. These scores are based on clinical, laboratory, and/or imaging measures. Although they are frequently used in clinical practice, they have important limitations. Disease activity scores are often based on unspecific and sometimes subjective variables that significantly increase their inter- and intra-observer variability, clearly reducing their accuracy and, consequently, affecting disease monitoring. Objective molecular scores will indicate adequate disease control and may serve as early markers for relapse, therapy escalation and tailored treatments. The resulting improvement of patient management will lead to increased patient well-being and reduced net health care costs.

Hence the improvements in the prediction of disease progression and therapy response will not only be of great benefit to the patient but will also significantly reduce the socio-economic burden of these diseases.

Non-invasive treatment options

Clinical surveillance of immune-mediated inflammatory diseases is hindered by the fact that target tissues or organs can only be sampled by invasive procedures (e.g. biopsy).

The use of circulating signatures or ‘disruptive’ liquid biopsy (e.g. blood) forced by non-invasive technologies could help to replace the need for invasive biopsy procedures. The direct relationship with blood composition strongly supports the hypothesis that different molecular species present in both biological fluids like metabolites, nucleic acids, or proteins and whose variation is associated with pathological features could be highly informative biomarkers.

Thus, the dynamic nature and highly informative properties of biological molecules (i.e. biomarkers) defined using non-invasive technologies could provide a new level of innovation, precision and accuracy.

Regulatory approval

The long-term achievements of ImmUniverse will have a profound impact on the regulatory landscape of immune-mediated inflammatory disease. With the new molecular stratification tools and ‘hard’ molecular endpoints for disease control on the individual patient level, the approach is expected to strongly influence clinical trial design for regulatory approval and, ultimately, on reimbursement strategies by health care systems (e.g. by providing an accepted rationale for therapy escalation or change).

New biomarkers for improved treatment success

The combination of a retrospective analysis of well-characterised bio samples together with the prospective standardised recruitment during the project will allow a better understanding of the link between the molecular characteristics of disease and non-response to targeted drug treatments. This will lead to the identification of biomarkers that would increase the likelihood of treatment success.

This, in turn, will have an impact on individual patients and societal costs. Circulating signatures of the tissue microenvironment will advance clinical monitoring in both clinical trials and standard patient care. Once validated, they will help in earlier and/or improved detection of disease progression and prediction of treatment response. Moreover, the non-interventional trial will allow signature verification and facilitate implementation in future clinical trials and adoption by regulatory authorities.