This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

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.

4 of 9

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,195.42 +221.11 1.30%
S&P 500 0.00 -2.75 -0.14%
NASDAQ 4,566.1380 +16.9120 0.37%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs