Background：Sirukumab developmental code name CNTO-136 is a human monoclonal antibody mAb designed for the treatment of rheumatoid arthritis RA. It acts against the proinflammatory cytokine interleukin IL -6 IL-6. Sirukumab was evaluated in five Phase 3 studies of patients with RA. In September 2016, Janssen submitted a biologics license application BLA seeking approval of sirukumab for the treatment of moderately to severely active RA, but they announced in September 2017 that they received a complete response letter from the Food and Drug Administration FDA indicating additional clinical data were needed to further evaluate the safety of sirukumab in that patient population. Janssen subsequently decided not to pursue global approvals of sirukumab for the treatment of moderately to severely active RA. Sirukumab was being evaluated in a Phase 3 study NCT02531633 of another inflammatory disease, giant cell arteritis. This study, sponsored by GlaxoSmithKline GSK, was terminated in November 2017 due to GSK’s decision to return rights to sirukumab to Janssen and discontinue sirukumab development in giant cell arteritis. Also, in November 2017, a Phase 3 study NCT02899026 sponsored by GSK of sirukumab in patients with polymyalgia rheumatica, an inflammatory disorder that causes muscle pain and stiffness, was withdrawn prior to enrollment.
