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Tocilizumab for the treatment of rheumatoid arthritis

Javier Rueda-Gotor, Miguel A González-Gay and Ricardo Blanco

Tocilizumab (TCZ) is a humanized monoclonal antibody against the IL‑6 receptor, approved in Japan, Europe and the USA for the treatment of severe rheumatoid arthritis. Several Phase III trials have shown a clinical efficacy of TCZ, such as in treatment of rheumatoid arthritis patients with no previous methotrexate failures both in combination with methotrexate and in monotherapy (the AMBITION trial); and rheumatoid arthritis patients who are resistant to disease-modifying antirheumatic drugs (the TOWARD, OPTION and LITHE trials) and anti-TNF‑a agents (the RADIATE trial). Some of these Phase III trials have alsodemonstrated the radiologic efficacy of TCZ (the LITHE and SAMURAI trials) as well as its
good safety profile, similar to other biologic agents. The effectiveness and safety of TCZ in a
setting closer to clinical practice than that typically described in Phase III studies have recently
been revealed by some Phase IIIb studies (the TAMARA, ROSE, ACT‑SURE, ACT‑RAY and ACT STAR studies) and the nationwide Danish registry.