Tocilizumab for rheumatoid arthritis: results of the Phase III clinical trial program

Javier Rueda, Miguel A Gonzlez-Gay, Ricardo Blanco

Tocilizumab (TCZ) is a humanized monoclonal antibody targeting the receptor for IL-6 that has been approved in Japan, Europe and the USA for the treatment of rheumatoid arthritis (RA). Several Phase III trials have shown clinical efficacy of TCZ in the majority of clinical situations; namely RA with no previous methotrexate failures (AMBITION study), RA resistant to disease-modifying antirheumatic drugs (TOWARD, OPTION and LITHE studies) and anti-TNF-a agents (RADIATE). TCZ is usually used in RA in combination with methotrexate but it may also be used as monotherapy (AMBITION study). Radiological efficacy has also been demonstrated (SAMURAI and LITHE studies). In general, TCZ has a good safety profile. This article will specifically review the Phase III clinical trials related to clinical and radiological efficacy as well as safety of TCZ in RA.