Positive Phase III results from three trials announced for sirukumab for treatment of RA- GSK + Janssen Biologics

GSK announced it has received positive top-line results from the phase III programme investigating sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody for the treatment of patients with moderately to severely active rheumatoid arthritis (RA), in development as part of a collaboration with Janssen Biologics. There were no unexpected safety findings relative to the known effects of IL-6 inhibitors. Long term safety and efficacy data are currently being collected in ongoing extensions of the phase III trials. Regulatory applications for sirukumab for RA are anticipated in 2016. Full results from the three pivotal studies will be presented at forthcoming scientific conferences and submitted for publication in peer-reviewed journals. Sirukumab is currently not approved as a treatment for any indication anywhere in the world.

About the studies:

1. SIRROUND-D (CNTO136ARA3002) is a multicentre, randomised, double-blind, placebo-controlled, parallel group study in 1670 patients with moderately to severely active RA who were unresponsive to disease-modifying antirheumatic drugs (DMARDs). The primary objective was to assess the efficacy of subcutaneous sirukumab as measured by the reduction of the signs and symptoms of RA and inhibition of radiographic progression.
2. SIRROUND-H (CNTO136ARA3005) is a multicentre, randomised, double-blind, parallel-group study comparing subcutaneous sirukumab with adalimumab (an anti-tumor necrosis factor (TNF) monoclonal antibody), each given as monotherapy in 559 biologic naïve patients with moderately to severely active RA who were intolerant to methotrexate, who were considered inappropriate for treatment with methotrexate or who were unresponsive to methotrexate. The primary objective was to assess the efficacy of each treatment as monotherapy.
3. SIRROUND-T (CNTO136ARA3003) is a multicentre, randomised, double-blind, placebo-controlled, parallel group study of sirukumab in 878 patients with active RA who were unresponsive or intolerant to anti-TNF agents. The primary objective was to assess the efficacy of subcutaneous sirukumab as measured by the reduction of the signs and symptoms of RA.

Comment: A further two studies are in development namely, SIRROUND-M in Japanese patients unresponsive to methotrexate or sulfasalazine and a long term extension study for patients completing SIRROUND-D and SIRROUND-T (SIRROUND-LTE).