UCB announced results from several Phase III clinical trials evaluating CIMZIA(R) (certolizumab pegol) - the only PEGylated anti-TNF (Tumor Necrosis Factor) - presented at the American College of Rheumatology (ACR) Annual Scientific Meeting. Results from the open-label extension study to RAPID 1 met both co-primary endpoints (American College of Rheumatology (ACR) 20 response(a) scores at Week 24 and change from baseline in modified Total Sharp Scores at Week 52). Results also showed that CIMZIA together with methotrexate (MTX) provided ACR 20 response as early as Week 1 with sustained long-term benefit in relieving symptoms of rheumatoid arthritis (RA) through 100 weeks.
Another analysis investigating the rapidity of response to CIMZIA as a monotherapy (FAST 4WARD) and together with MTX (RAPID 1) was presented at the meeting. Both studies met their primary endpoints (ACR20 response rate at Week 24) with clinical and statistical significance. The analysis presented showed that the response to CIMZIA treatment was rapid in both studies with more than a third (36.7 percent) of patients receiving CIMZIA as a monotherapy (FAST 4WARD) and nearly a quarter (22.9 percent) of patients receiving CIMZIA together with MTX (RAPID 1) achieving an ACR20 response within one week, both significantly different from placebo. ACR20 response rates peaked at Week 12 in both studies and were sustained until the end of the studies (Week 24 in FAST 4WARD; Week 52 in RAPID 1).
"The data show that treatment with CIMZIA in clinical trials produced a fast and clinically meaningful effect for RA patients over an extended period of time," said Michael Schiff, M.D., study investigator and Clinical Professor of Medicine at the University of Colorado School of Medicine.
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