Janssen announced positive results from the SIRROUND-D study, a pivotal Phase 3 trial evaluating subcutaneous sirukumab (CNTO 136) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
SIRROUND-D (CNTO136ARA3002) is a multicenter, randomized, double-blind, placebo-controlled, parallel group study in 1,670 patients with moderately to severely active RA who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients received either sirukumab 50mg every 4 weeks, sirukumab 100mg every 2 weeks or placebo. The co-primary endpoints were inhibition of radiographic progression, or joint destruction, as measured by the van der Heijde-Sharp score at Week 52, and reduction of the signs and symptoms of RA as measured by the American College of Rheumatology (ACR20) at Week 16.
Study data showed that treatment with sirukumab demonstrated significant inhibition of radiographic progression from baseline to Week 52 and improvement in signs and symptoms of RA at Week 16 compared to placebo, meeting both co-primary endpoints. The mean change from baseline to Week 52 in the van der Heijde-Sharp score was 0.50, 0.46, and 3.69 in patients treated with sirukumab 50mg every 4 weeks, sirukumab 100mg every 2 weeks, and placebo, respectively (P=0.001 for both). Higher van der Heijde-Sharp score correlates to greater structural damage. ACR20 at Week 16 was achieved by 54.8% and 53.5% of patients receiving sirukumab 50mg and sirukumab100 mg, respectively, vs. 26.4% of patients receiving placebo (P=0.001 for both).
All major secondary endpoints were also met with statistical significance for both doses of sirukumab vs. placebo, including the change from baseline in the health assessment questionnaire disability index (HAQ-DI), percentage of patients achieving ACR50, percentage of patients with improved disease activity score in 28 joints (DAS28 Remission [DAS28 (CRP) <2.6]) at Week 24, and percentage of patients achieving ACR70 for six consecutive months by Week 52 (P=0.001 for all for both doses). Adverse events (AEs) and serious AEs were higher in sirukumab-treated patients vs. placebo during the 18-week control period, with the most common being elevated liver enzymes, upper respiratory tract infection, injection site erythema and nasopharyngitis. Data from this study is scheduled for presentation at the Annual European Congress of Rheumatology 2016.
Sirukumab is an investigational, human anti-interleukin (IL)-6 monoclonal IgG1 kappa antibody.
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