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Cimzia® (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
Date:5/10/2011

>Adverse Reactions

In controlled Crohn's clinical 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 treat
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SOURCE UCB
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Related medicine technology :

1. New Cimzia® (certolizumab pegol) Data Show a Significant, Rapid Clinical Response and Reduced Disease Activity Among Diverse Patient Populations With Active Rheumatoid Arthritis (RA)
2. Rapid and Long-term Clinical Responses Observed in Rheumatoid Arthritis Patients Taking Cimzia® (certolizumab pegol), According to Data Being Highlighted During ACR Meeting
3. UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohns Disease
4. Long-Term Data on Cimzia® (certolizumab pegol) for Moderate to Severe Crohns Disease to be Highlighted at ACG Meeting
5. New Data Show CIMZIA(R) (certolizumab pegol) Provides Sustained and Significant Symptom Improvement in Moderate to Severe Crohns Patients
6. CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years
7. CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohns Disease Patients
8. CIMZIA(R) (certolizumab pegol) Reduces Intestinal Lesions and Induces Endoscopic Improvement in Crohns Patients
9. CIMZIA(R) (certolizumab pegol), Significantly Reduces Structural Damage and Rheumatoid Arthritis Signs & Symptoms for Up to One Year
10. New Subanalyses of the RE-LY Trial Showed Pradaxa Reduced Stroke Risk in Patients With Varying CHA2DS2-VASc Scores and Types of Non-Valvular Atrial Fibrillation
11. Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial
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