In patients with rheumatoid arthritis (RA) refractory to methotrexate, addition of certolizumab pegol significantly improved symptoms, inhibited radiographic progression of joint damage, and increased physical function and health-related quality of life.
"Certolizumab pegol is a PEGylated Fab' fragment of a humanized anti-TNF antibody with high affinity to TNF," Dr. Josef Smolen of the University of Vienna, Austria, and colleagues explain in the June issue of the Annals of the Rheumatic Diseases. The researchers add that because the agent lacks an Fc region, potential Fc-mediated effects (such as complement- or antibody-dependent cell-mediated cytotoxicity) might be avoided. Attachment of the PEG moiety to the Fab' fragment produces a molecule with a plasma half-life of approximately 2 weeks, they note. In the RA Prevention of Structural Damage 2 (RAPID 2) study, 619 patients with active RA despite at least 6 months of methotrexate therapy were randomly assigned to receive add-on treatment with subcutaneous certolizumab pegol, 400 mg at weeks 0, 2, and 4 followed by 200 mg or 400 mg plus MTX, or placebo plus MTX every 2 weeks for 24 weeks. According to the investigators, American College of Rheumatology 20% improvement criteria (ACR20) were met by 57.3% of patients in the certolizumab pegol 200 mg arm, 57.6% in the 400 mg arm, and 8.7% in the placebo group. "Statistically significant and clinically meaningful" differences between placebo and both certolizumab doses were evident not only with respect to the primary end point (ACR20) but also for all secondary end points -- ACR50, ACR70, ACR core set variables such as swollen and tender joint counts, changes in Disease Activity Scores in 28 joints (DAS28) and DAS28 remission, Dr. Smolen and colleagues report. These clinical benefits were achieved as early as 1 week after the start of certolizumab pegol, "in this population of patients with severe disease (91% with DAS28 greater than 5.1 at baseline)," they point out. Compared with placebo and MTX, certolizumab pegol plus MTX significantly inhibited the progression of structural joint damage, as demonstrated by significantly lower mean changes from baseline in the modified Total Sharp Score (mTSS) in the treatment groups. Mean changes from baseline in mTSS at week 24 were 0.2 and -0.4, respectively, in the certolizumab 200-mg and 400-mg arms, versus 1.2 in the placebo arm. Physical function and health-related quality of life also improved rapidly and significantly with the addition of certolizumab relative to placebo, as assessed by the disability index of the Health Assessment Questionnaire and the Short Form-36 Health Survey. "Most adverse events were mild or moderate, the researchers report, "with low incidence of withdrawals due to adverse events." Based on studies to date, certolizumab pegol "expands the treatment armamentarium for patients with RA," the researchers conclude. Given that there were no noteworthy differences in clinical efficacy between the two dose-treatment groups, "a 200 mg dose every 2 weeks is optimal for treatment," they suggest. Ann Rheum Dis 2009;68:797-804.
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Anyone here using Cimzia?Bump