Sirukumab monotherapy improved signs and symptoms of rheumatoid arthritis (RA) compared with improvements seen with adalimumab monotherapy in biologic-naive patients who were unresponsive to methotrexate, according to the results of the SIRROUND study (ClinicalTrials. gov Identifier: NCT02019472) published in the Annals of the Rheumatic Diseases.
Researchers randomly assigned patients to receive either subcutaneous sirukumab 100 mg every 2 weeks (n=187), sirukumab 50 mg every 4 weeks (n=186), or adalimumab 40 mg every 2 weeks (n=186). Primary end points were the change in Disease Activity Score in 28 joints (DAS28) from baseline to 24 weeks and the percentage of patients achieving an American College of Rheumatology (ACR) 50 response.
The results showed significantly greater improvement in mean DAS28 scores at 24 weeks with sirukumab 100 mg every 2 weeks (–2.96) vs adalimumab 40 mg every 2 weeks (–2.19; P <.001). In addition, sirukumab 50 mg every 4 weeks showed greater improvement (–2.58) compared with adalimumab (P =.013).
However, the investigators found that ACR50 response rates were comparable in the sirukumab 100 mg (35.3%) and 50 mg (26.9%) groups vs adalimumab (31.7%) at 24 weeks. The safety profile of sirukumab was consistent with the safety profile observed with anti-interleukin-6 receptor antibody treatment.
“Both sirukumab and adalimumab showed early efficacy, with improvements in RA signs and symptoms as early as week 2,” the investigators concluded. “Overall, improvements in measures of signs and symptoms, physical function, and patient-reported outcomes were generally similar across the sirukumab and adalimumab groups.”
Taylor PC, Schiff MH, Wang Q, et al. Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study [published online February 26, 2018]. Ann Rheum Dis. doi:10.1136/annrheumdis-2017-212496