Background/Purpose The use of objective biomarkers of clinical disease characteristics such as disease activity would be beneficial in informing patients, physicians and payers. Recently, a number of potential biomarkers for RA disease diagnosis, prognosis and activity have been described in the literature. However, the majority of these have not been validated in independent cohorts. 

Methods We assessed the performance of available biomarkers of RA disease as well as developed and validated novel tests using samples from multiple cohorts of moderate to severe RA patients. Serum samples from subjects enrolled in two Phase III studies (GO-FURTHER and GO-SAVE; clinicaltrials.gov – NCT00973479 and NCT01004432) and a Phase II study (NCT00718718) were obtained at multiple timepoints. Using samples from the GO-FURTHER (NCT00973479) cohort we evaluated commercially available correlates of disease activity as well as developed novel molecular readouts of disease activity. 

Results We were able to develop two serum-based alternatives to DAS28-CRP score with similar performance using both informed and inclusive approaches to protein selection. The two tests were developed using a set of proteins profiled via ELISA; and a highly multiplexed (SomaLogic) proteomic platform. The tests had consistently good performance in samples from cross-validation runs and samples from same subjects left out of the modeling step. We have also observed similar or better performance in patients enrolled in independent cohorts coming from other two clinical trials and additional replication is underway. 

Conclusion Validation of objective biomarkers of clinical disease state is important for advancing the evaluation and comparison of novel therapeutics in RA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/proteomic-phenotyping-of-rheumatoid-arthritis-disease-activity/