This study showed that in refractory and difficult-to-treat patients with RA, subcutaneous sirukumab achieved rapid and continuous improvements to disease activity, as well as improvements in physical function and health status. The treatment is an effective biologic with a different mechanism of action and a positive safety profile. In September 2016, a Biologics License Application was submitted to the U.S. Food and Drug Administration, seeking approval for sirukumab to treat adults with moderate to severe active RA.2
Sirukumab is also currently in Phase 3 clinical trials for giant cell arteritis.3
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Aletaha D, Bingham CO, Tanaka Y, et al. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomized, double-blind, placebo-controlled, parallel-group, multi-national, Phase 3 study. The Lancet. 2017 Feb 15. pii: S0140-6736(17)30401-4. doi: 10.1016/S0140-6736(17)30401-4. [Epub ahead of print]
- Janssen Pharmaceutical Co. of Johnson & Johnson. News release: Janssen submits application seeking approval of sirukumab in United States for rheumatoid arthritis. 2016 Sept. 23
- GlaxoSmithKline plc. GSK pipeline Phase III: Sirukumab. 2017.
