The co-primary endpoints of the SIRROUND-D study in RA patients who had an inadequate response to treatment with disease-modifying anti-rheumatic drugs (DMARDs) showed that:
- Inhibition of radiographic progression, or joint destruction, was significantly greater among sirukumab-treated patients, with a mean change from baseline to week 52 in the van der Heijde-Sharp score of 0.50 among patients receiving sirukumab 50mg every four weeks (n=557) and 0.46 for patients receiving sirukumab 100mg every two weeks (n=557) compared with 3.69 among the placebo group (n=556) (both P < 0.001). The van der Heijde-Sharp scoring method is an X-ray measure of changes in joint destruction and damage, including joint erosion and joint space narrowing. With this method, higher scores indicate greater structural damage while lower scores indicate less structural damage. Significant inhibition of radiographic progression was demonstrated in both patients naïve to biologic therapy and those treated with biologics in the past, and was seen as early as week 24.
- At least a 20 percent improvement in RA signs and symptoms as measured by the American College of Rheumatology response criteria (ACR20) at week 16 was achieved by 54.8 percent and 53.5 percent of patients receiving sirukumab 50mg and sirukumab 100mg, respectively, compared with 26.4 percent of the placebo group (both P < 0.001).
