Emerging approaches for the therapy of autoimmune and chronic inflammatory disease.

Progress in defining protein and gene signatures that characterize autoimmune-mediated inflammatory diseases has uncovered a large number of potential therapeutic targets. Preclinical data from rodent models can be generated rapidly, as can data from the genetic crosses of gene-deficient mice on autoimmune-susceptible backgrounds. But humans are not the same as mice, and however robust preclinical data might appear, therapeutic intervention in patients with autoimmune disease remains the definitive experiment. Several studies published in the past year have tested paradigms of autoimmune disease in clinical trials. Recent therapeutic approaches for targeting B-cell subsets and co-stimulatory pathways are described here in detail. It is our belief that the future of immunotherapy in the clinic will depend to some extent upon the availability of biomarkers for defining biological signatures of immune function in vivo.