Sirukumab Effective in Rheumatoid Arthritis Save

Sirukumab is a human monoclonal antibody that selectively binds to the interleukin-6 (IL-6) and is being developed for use in rheumatoid arthritis (RA) and other inflammatory diseases.

Investigators have reported the results of the pivotal phase 3 study (SIRROUND-T), testing the efficacy and safety of sirukumab in RA. 

This multicenter, multinational trial of 878 RA patients  with active disease (despite DMARD, methotrexate (MTX) or TNF inhibitors) were randomized  (1:1:1) to receive either placebo every 2 weeks, 50 mg sirukumab every 4 weeks, or 100 mg sirukumab every 2 weeks, all given for 52 weeks or less.

The majority (60%) had previously received two or more biological treatments, including non-TNF drugs, and 19% were not taking a DMARD at baseline.

ACR20 responses at week 16 were 40% for 50 mg sirukumab every 4 weeks, and 45% for 100 mg sirukumab every 2 weeks compared to 24% on placebo.

Adverse event incidences in the 24-week placebo-controlled period were similar across groups and comparable to other IL-6 inhibitors.

The SIRROUND-T trial shows that both dosing regimens of sirukumab were well tolerated and improved signs and symptoms of RA.  While the results seen in this heterogeneous populatoin were less than that expected, more studies of sirukumab in RA are needed to affirm its efficacy and safety in RA.