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news.UCB has released results from REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) Phase IIIb clinical trial evaluating Cimzia (certolizumab pegol).
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The study results demonstrated that the addition of Cimzia to current therapy showed rapid and consistent efficacy across the patients taking certolizumab pegol whether they had previously received TNF inhibitors or not and whether they received certolizumab pegol monotherapy or with concomitant DMARDs.
The addition of certolizumab pegol to current therapy also showed reductions in fatigue and sleep problems, as well as improvements in pain and patient-assessed disease activity (PtGA) compared to the placebo group.
The treatment with certolizumab pegol was generally well tolerated in the REALISTIC Phase IIIb study population and subgroup analyses.
In the overall study population, ACR20 response rates at Week 12 were statistically significantly higher in the certolizumab pegol group (51.1%) compared to placebo (25.9%).
University of Western Ontario Department of Medicine Janet Pope said these results demonstrate that the benefits of treatment with certolizumab pegol extend into areas that are meaningful for patients in terms of quality of life.