Efficacy and Safety of Sirukumab in Patients with Active Rheumatoid Arthritis Refractory to Anti-TNF Therapy (SIRROUND-T): A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multinational, Phase 3 Study
In this Phase 3 multicentre, randomised controlled trial in patients with active RA who were refractory or intolerant to previous biological treatment with at least one TNF inhibitor, sirukumab 50 mg every four weeks (Q4W) or 100 mg every two weeks (Q2W) was well tolerated and significantly improved signs and symptoms of disease.
Patients were randomised 1:1:1 to placebo (n=294), sirukumab 50 mg Q4W (n=292) or sirukumab 100 mg Q2W (n=292), while continuing any concomitant DMARDs. Of the 878 randomised patients, 523 (60%) had previously taken two or more biological treatments including non-TNF drugs; 712 (81%) patients were taking a DMARD at baseline.
The primary efficacy endpoint was the proportion of patients achieving an ACR20 response at Week 16. This was achieved by 117 (40%) of patients taking sirukumab 50 mg Q4W and 132 (45%) of those taking sirukumab 100 mg Q2W, compared with 71 (24%) of the placebo group. Adverse event rate was similar across the groups, with injection-site erythema the most common.
Sirukumab had favourable clinical and functional effects across different subgroups of patients in this difficult-to-treat population.