May 31, 2011
Phase 3b Study of Cimzia for Rheumatoid ArthritisUCB Inc. announced additional data from its subgroup analysis of the REALISTIC Phase 3b study of Cimzia (certolizumab pegol) for the treatment of rheumatoid arthritis (RA). Consistent efficacy was observed across patients taking Cimzia whether they had previously received TNF inhibitors or not and whether they received Cimzia monotherapy or with concomitant DMARDs. In the overall study population, ACR20 response rates at Week 12 were statistically significantly higher in the Cimzia group (51.1%) compared to placebo (25.9%). There was no significant difference in response rates among patients in the Cimzia group who had previously been treated with TNF inhibitors (47.2%) and those who had not (53.5%), and similarly no significant difference among patients receiving Cimzia monotherapy (47.6%) compared to those receiving concomitant DMARDs (52.0%).
Further analysis of the study revealed that the addition of Cimzia to current therapy was associated with clinically meaningful reductions in fatigue and sleep problems, as well as improvements in pain and patient-assessed disease activity (PtGA) compared to the placebo group. At Week 12, significantly more patients in the Cimzia group compared to the placebo group experienced improvements in fatigue (56.4% vs. 46.2%, P<0.01), sleep problems (49.7% vs. 42.5%, P=0.058), pain (59.0% vs. 42.0%, P<0.001) and PtGA (59.5% vs. 42.5%, P<0.001). Significant reductions in fatigue, pain and PtGA were recorded as early as Week 2 in the Cimzia group.
Cimzia is indicated for the treatment of adults with moderate-to-severe RA. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate
For more information call (866) 4 CIMZIA or visit www.cimzia.com