Diagnosis and prognosis biomarkers: presence, extension and evolution of skin and lung fibrosis in systemic sclerosis

Leader: David Launay

Workpackage: WP4

Currently, only the subjective assessment of cutaneous induration has been validated as a measure of the extent and severity of SSc and for monitoring the effects of therapeutic interventions on disease progression. There is an important unmet need for novel, validated, non- invasive biomarkers for the improvement and development of cogent and effective clinical management for patients with SSc. Moreover, the comparison of novel biomarkers found in topics 7 & 8 will be useful to assess the most universal biomarkers for fibrosis extension, either in gut, lung or skin.

In this task, we use the existing cohort of patients with SSc. To date, 280 patients have at least 2 visits with a biobanking at the first visit. In this task, we assess which biomarkers at baseline is predictive of i) the presence and extension of skin and lung fibrosis at baseline ii) the evolution of skin fibrosis (as measured by the validated assessment of the cutaneous induration (modified Rodnan skin score) and lung fibrosis, as assessed by the extension on high resolution CT scan and pulmonary function tests. This allows assessing whether first, the biomarker levels correlate with the fibrosis extension, and second, the biomarker levels correlate with the evolution of the fibrosis, an usual clinical endpoint. We assess existing biomarkers as in task 3.2 and perform a biomarker discovery thanks to a nanoHPLC/nanoESI/HR MS proteomic analysis of plasma. The statistical analysis is performed by Bilille (https://wikis.univ-lille1.fr/bilille/).