Serious and sometimes fatal side effects have been reported with Cimzia®, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. In pre-marketing controlled trials of all patient populations combined the most common adverse reactions (greater than or equal to 8%) were upper respiratory infections (18%), rash (9%) and urinary tract infections (8%).
*About RAPID 1
RAPID 1 is a Phase III double-blind placebo-controlled trial, involving 982 adults, that was designed to establish the efficacy and tolerability of certolizumab pegol together with MTX, in the treatment of active RA in patients who did not adequately respond to conventional treatment. Patients were randomly allocated to receive one of three treatment regimens: 393 patients received certolizumab pegol 400 mg and at Weeks 0, 2 and 4, then 200 mg every two weeks; 390 patients received certolizumab pegol 400 mg every 2 weeks; 199 patients received placebo every 2 weeks. RAPID 1 met co-primary endpoints: ACR20 response rate at Week 24 and change from baseline in mTSS at Week 52. Significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo (p less than or equal to 0.001); rates at Week 24 were 58.8%, 60.8%, and 13.6%, respectively, and remained significant at Week 52 (p less than or equal to 0.001). Certolizumab pegol 200 mg and 400 mg also significantly inhibited radiographic progression; mean changes from baseline in mTSS at Week 52 were 0.4 and 0.2, respectively, versus 2.8 for placebo (rank analysis p less than or equal to 0.001). Certolizumab pegol treated patients reported rapid, significant and clinically meaningful improvements in physical function versus placebo (p less than
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