Methods for treating IL-6-related diseases (US2015010554A1): a patent evaluation

IL-6 is involved in a variety of diseases such as acute or chronic inflammation and autoimmune diseases, and the modulation of IL-6 level is recognized as an important target. Therefore, the blocking agent of IL-6 receptor (IL-6R), particularly anti-IL-6R antibody, was invented and its clinical efficacy was well resolved. However, it has not been shown that synergistic effects can be achieved by the combination of anti-IL-6R antibody with immunosuppressants.

This patent assessed the possible use of anti-IL-6R antibody (tocilizumab) plus methotrexate (MTX) for the treatment of acute or chronic inflammatory diseases and autoimmune diseases including nephritis, Crohn's disease, ulcerative colitis, pancreatitis, juvenile idiopathic arthritis, rheumatoid arthritis, and psoriasis. A large Phase II trial of tocilizumab to determine the optimum dose of tocilizumab alone and in combination with MTX for the treatment of rheumatoid arthritis was carried out and its result was analyzed. In conclusion, the combination use of tocilizumab plus MTX was confirmed as clinically effective and safe for the treatment of rheumatoid arthritis whereas substantial evidence regarding superiority to tocilizumab monotherapy is still lacking.

To prove synergistic effect or enhancement of tocilizumab plus MTX therapy, more diverse diseases related to IL-6 and tocilizumab therapy, not limited to rheumatoid arthritis, have to be evaluated, along with its safety.