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Autoimmune diseases are a heterogeneous group of disorders and epidemiological studies demonstrate that their incidence is increasing worldwide. A complex interaction of genetic and environmental factors underlies their etiopathogenesis. It is certainly recognised that the pathogenesis of these disorders, their diagnosis and therapy is a ‘hot topic’ and one of the most intriguing subjects in medicine. Hopefully, the most recent findings may provide insights into future developments. In this issue, internationally recognised experts in the field have contributed providing an excellent overview of recent therapeutic strategies and of experimental approaches leading to future perspectives. I hope these papers may contribute a new view for treatment. I have first introduced the preliminary results of novel therapeutic approaches and novel experimental strategies including antagonists of cytokines and cytokine receptors, inhibitors of Toll like receptors, proteasome inhibitors, antisense oligonucleotides to common susceptibility genes vehicled by nanocarriers, inhibitors of leukocyte migration and kinase inhibitors. I have also presented the results of ongoing trials in humans that rely on these novel biologicals in reference to both organ and non-organ specific autoimmune disorders. Professor Delfino and collaborators (Department of Clinical and Experimental Medicine, University of Perugia, Italy) reviewed the role of the thymus in the pathogenesis of autoimmune diseases and envisages that future therapeutic strategies should exploit manipulations in the negative selection process and/or the differentiation of T regulatory cells. Professor Czaja (Mayo Clinic College of Medicine, Rochester, Minnesota) highlighted promising pharmacological, molecular and cellular interventions for autoimmune hepatitis. Feasible new drugs include calcineurin-inhibitors, next generation purine antagonists and glucocorticoids, inhibitors of the mammalian target of rapamycin. Possible molecular interventions utilize recombinant molecules that affect immunological regulatory pathways, monoclonal antibodies that halt activation pathways and synthetic peptides that affect antigen exposure or induce antigen tolerance. In reference to rheumatoid arthritis the review of Professor McDermott and collaborators (Leeds Institute of Molecular Medicine, Wellcome Trust Brenner Building, St James's University Hospital, Leeds, UK) focused on the role of tumor necrosis factor (TNF) in the pathogenesis of the disease. Anti-TNF agents were the first therapeutic agents to be successfully employed in the treatment of rheumatoid arthritis. Their mechanism of action, adverse effects and safety were presented and the development of biosimilars was discussed. Dr Rosado and collaborators (Research Laboratories, Children's Hospital Bambino Gesu, Rome Italy) provided an extensive review of therapeutic strategies alternative to conventional immunosuppression for the treatment of systemic lupus erythematosus. These include the use of new drugs targeting the Toll like receptor/MyD88 pathway and immunomodulators interfering with B-cell specific pathogenetic pathways.....