Biomarker-guided stratification of autoimmune patients for biologic therapy

•Validated biomarkers for predicting therapy response in autoimmunity are lacking.•Lack of standardization and independent validation impedes biomarker development.•Immune biomarkers must integrate patient-specific genetic and environmental factors.•Optimal pairing of patients with therapies requires multi-platform strategies.

Autoimmunity results from an intersection of genetic and environmental factors that cause patient-specific perturbations in immune homeostasis. Defining autoimmunity-associated genetic factors has led to mechanistic insight into underlying etiologies, and the development of many biologic therapies that target the immune system. However, biomarker-informed pairing of patients with optimal biologic therapy is lacking. Here, we discuss platforms commonly used to find biomarkers that predict response to biologic therapy in autoimmunity and highlight recent biomarker discoveries. We also outline how the lack of assay standardization is a barrier to successful biomarker validation. Finally, we argue that the successful development of companion biomarkers for biologic therapy requires collaborative approaches that integrate multiple platforms and enable comprehensive measurement of multiple immune pathways.