Phase III trials of CNTO 136 (sirukumab) shows improvement versus Humira (adalimumab) monotherapy in rheumatoid arthritis - Janssen

Janssen Research & Development announced results from two pivotal Phase III studies evaluating subcutaneous CNTO 136 (sirukumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). Data from the Janssen-sponsored head-to-head study, SIRROUND-H, showed patients receiving sirukumab monotherapy demonstrated significantly greater improvement in Disease Activity Score (DAS28), the first of two co-primary endpoints, when compared with Humira (adalimumab) monotherapy.

In SIRROUND-H, a comparator study of sirukumab monotherapy versus adalimumab monotherapy, patients receiving sirukumab 50 mg every four weeks (q4w) and patients receiving sirukumab 100 mg every two weeks (q2w) experienced significant mean changes from baseline in DAS28 at week 24 of -2.58 and -2.96, respectively, one of two co-primary endpoints of the study, compared with a mean change of -2.19 in patients receiving adalimumab 40 mg q2w.

Investigators also reported results from a second study (SIRROUND-T), which showed that patients refractory to or intolerant to one or more anti-tumor necrosis factor (TNF) treatments receiving sirukumab demonstrated significant improvement in signs and symptoms of active RA compared with placebo. In SIRROUND-T, among patients refractory/intolerant to anti-TNF treatments, 40 percent of patients receiving sirukumab 50 mg q4w and 45 percent of patients receiving sirukumab 100 mg q2w achieved the study's primary endpoint, at least a 20 percent improvement in signs and symptoms (ACR20) at week 16, compared with 24 percent of patients receiving placebo. Data were presented at the 2016 ACR/ARHP Annual Meeting.