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UCB Announces Data On Cimzia® (certolizumab Pegol) For Patients With Moderate To Severe Rheumatoid Arthritis At American College Of Rheumatology 2012 Congress

*Certolizumab pegol in combination with methotrexate is approved in the European Union as a maintenance regimen of 200 mg every two weeks. The certolizumab pegol dosing regimen of 400 mg every four weeks is not approved in the European Union.

Two presentations provided findings on the safety and efficacy profile of certolizumab pegol

Presentation Title: Long-Term Safety and Efficacy of 4-Weekly Certolizumab Pegol in Combination with Methotrexate and as Monotherapy in Rheumatoid Arthritis: 5 Year Results from an Open-Label Extension Study

    • Monday, November 12, 2012, from 9:00 AM - 6:00 PM
    • Location: WCC: Poster Hall (Hall B)

A post-hoc analysis provided additional five-year safety and efficacy data on certolizumab pegol as monotherapy or combination therapy with non-biologic DMARDs. The open label extension study enrolled patients who withdrew from or completed two pivotal trials. A total of 402 patients were administered 400 mg of certolizumab pegol every four weeks*, either as monotherapy (126 patients) or in combination (276 patients), over five years. The post-hoc analysis found that certolizumab pegol administered as monotherapy or combination therapy is associated with improvement in disease activity and physical function. The event rates for all adverse events (AEs) and injection site reactions, serious adverse events, and serious neoplasms were lower among the monotherapy population than for all patients examined in the study. The event rates for serious infections, adverse events leading to withdrawal, and adverse events leading to death were low and similar between populations. Additionally, certolizumab pegol monotherapy patients had a similar retention rate to the overall study population.

*Certolizumab pegol in combination with methotrexate is approved in the European Union as a maintenance regimen of 200 mg every two weeks. The certolizumab pegol dosing regimen of 400 mg every four weeks is not approved in the European Union.

Presentation Title: Safety Update on Certolizumab Pegol in Patients with Active Rheumatoid Arthritis with Long-Term Exposure

    • Sunday, November 11, 2012, from 9:00 AM - 6:00 PM
    • Location: WCC: Poster Hall (Hall B)

A long-term safety update of certolizumab pegol in patients with active moderate to severe RA showed that no new safety signals were associated with treatment during the duration of the analysis. The update included 4,049 patients who received certolizumab pegol with a mean exposure of 2.1 years. The pooled analysis included 10 completed randomized controlled trials (RCTs) and their open-label extensions of certolizumab pegol in patients with RA. The cutoff date was November 30, 2011. Serious infectious events were the most common serious adverse events. In total, 43 tuberculosis infections occurred in 43 patients, 58 deaths occurred in certolizumab pegol patients (incidence rate [IR]: 0.63/100 PY) as a result of 19 cardiovascular events, 13 infections, 13 malignancies, and 18 other causes. Sixty-five certolizumab pegol patients in all studies developed malignancies (event rate: 0.72/100 PY), with 60 patients developing solid tumors (event rate: 0.67/100 PY) and five patients developing lymphoma (event rate: 0.05/100 PY). The safety profile of certolizumab pegol in this long-term safety analysis was consistent with previous experience, with no new safety signals identified.

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