Regulatory Aspects of New Medicines Targeted at Treatment of Autoimmune Diseases

Autoimmune diseases comprise a diverse group of clinical dis orders that result from the body's adaptive immune system reacting against its own tissues. 1 Conversely, autoinflammatory disorders encompass a more limited group of diseases distinguished by recurrent episodes of inflammation but in the absence of high‐titer autoantibodies and antigen‐specific T cells. 2 The past 15 years have seen a tremendous growth in the development of highly effective treatments for these diseases. Clinical Pharmacology & Therapeutics (2012); 91 4, 739–742. doi: 10.1038/clpt.2012.5