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Cimzia® (certolizumab pegol) Data Showed Rapid Improvement in Signs and Symptoms Predicted Better Long-Term Outcomes in Rheumatoid Arthritis Patients
Date:5/10/2011

inical trials, the most common adverse events that occurred in greater than or equal to 5% of certolizumab Pegol patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% certolizumab pegol, 13% placebo), urinary tract infection (7% certolizumab pegol, 6% placebo), and arthralgia (6% certolizumab pegol, 4% placebo).  The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for certolizumab pegol and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in greater than or equal to 3% of patients taking certolizumab pegol 200mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% certolizumab pegol, 2% placebo), headache (5% certolizumab pegol, 4% placebo), hypertension (5% certolizumab pegol, 2% placebo), nasopharyngitis (5% certolizumab pegol, 1% placebo), back pain (4% certolizumab pegol, 1% placebo), pyrexia (3% certolizumab pegol, 2% placebo), pharyngitis (3% certolizumab pegol, 1% placebo), rash (3% certolizumab pegol, 1% placebo), acute bronchitis (3% certolizumab pegol, 1% placebo), fatigue (3% certolizumab pegol, 1% placebo).  Hypertensive adverse reactions were observed more frequently in patients receiving certolizumab pegol than in controls.  These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and nonsteroidal anti-inflammatory drugs.  Patients receiving certolizumab pegol 400mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving certolizumab pegol 200mg every other week.  The proportion of patients who discontinued treatment due to adverse reactions in
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1. Cimzia® (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
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