Rheumatoid arthritis (RA) is an autoimmune disease, which has a negative impact on the ability to perform activities daily. Interleukin-6 (IL-6) wields pleiotropic biological effects that are crucially implicated in the activation of acute inflammatory response. Sirukumab is a monoclonal antibody with high affinity for IL-6. Areas covered: In this review, the authors examine sirukumab as a novel agent and its potential use in the treatment of RA focusing on the available data. Data from Phase I to Phase III indicate that sirukumab is generally safe and well tolerated by the patients with decreased inflammatory response. Sirukumab is currently awaiting approval by health authorities in Europe, the United States (U.S.) and Japan, as a subcutaneous (s.c.) therapy option for the treatment of adult patients with moderate to severely active RA. Expert opinion: Given the currently available literature on IL-6 and the IL-6 receptor antagonist tocilizumab, one could consider sirukumab as an attractive and promising alternative for RA therapy. Even if some Phase III trials are still ongoing and complete results are not fully available, sirukumab is clinically efficacious with a well-tolerated safety profile, and demonstrates non-inferiority when compared to TNFα inhibitors.
Keywords: Biologics; IL-6; SIRROUND trials; monoclonal antibody; rheumatoid arthritis; sirukumab.