First filings for GlaxoSmithKline and Janssen's IL-6 inhibitor sirukumab are on track for the third quarter, following the presentation at the weekend of the full data from the 1,670-patient SIRROUND-D study at the EULAR meeting in London, in which it met its co-primary endpoints of reducing the signs and symptoms of RA and inhibition of radiographic progression in adults with moderately to severely active rheumatoid arthritis. The top-line data were released last December.
Sirukumab produced significantly greater inhibition of radiographic progression, or joint destruction, with a mean change from baseline to week 52 in the van der Heijde-Sharp score of 0.50 among 557 patients receiving sirukumab 50 mg every four weeks and 0.46 for 557patients receiving sirukumab 100 mg every two weeks compared with 3.69 among the placebo group (n=556) (both p<0.001)
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