For patients with active rheumatoid arthritis (RA) who are not responding to disease-modifying antirheumatic drugs (DMARDs), sirukumab may represent a safe and effective treatment, according to results from a phase 3 trial published in the Annals of Rheumatoid Disease.1
For this multicenter randomized double-blind and placebo-controlled study (SIRROUND-D; ClinicalTrials.gov identifier NCT01604343), 1670 patients were assigned to receive sirukumab 100 mg every 2 weeks, sirukumab 50 mg every 4 weeks, or placebo every 2 weeks for 52 weeks, subcutaneously.
Study results indicate that a greater percentage of patients who had received 100 mg sirukumab or 50 mg sirukumab met American College of Rheumatology 20% response at 16 weeks compared with placebo (53.5% and 54.8% vs 26.4%; P <.001 for both).
Mean (standard deviation) change from baseline in modified Sharp/van der Heijde score at week 52 was significantly lower with 100 mg sirukumab (0.46 [3.26]) and with 50 mg sirukumab (0.50 [2.96]) compared with placebo (3.69 [9.25]; P <.001 for both).
“Sirukumab 100 mg every 2 weeks and 50 mg every 4 weeks led to significant reductions in RA symptoms, inhibition of structural damage progression and physical function and quality of life improvements, with an expected safety profile,” the researchers concluded.
One limitation of this study is that the population of patients with RA all were refractory to DMARDs, and some patients may not have received prior biologic therapy. The results of the study are not applicable to all patients with RA, “but provide important information on the use of anti-[interleukin]-6 therapy as a possible first-line or alternate biological therapy in patients who are no longer responding to conventional DMARDs,” the researchers noted.
Takeuchi T, Thorne C, Karpouzas G, et al. Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study [published online]. Ann Rheum Dis. doi:10.1136/annrheumdis- 2017-211328