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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Oral Apremilast Monotherapy Demonstrated Long-Term Clinical Benefits In Psoriatic Arthritis Patients Naïve To Previous DMARD Therapy

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of its long-term phase III study on apremilast, the Company’s first-in-class oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic or biologic DMARD-naïve psoriatic arthritis patients at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.

PALACE 4 is the first large, randomized, controlled study to examine the efficacy and safety of a novel agent exclusively in systemic or biologic DMARD-naïve psoriatic arthritis patients. Apremilast monotherapy demonstrated clinical benefits over 52 weeks in this treatment-naïve patient population, including clinically meaningful improvements in signs and symptoms of psoriatic arthritis, as well as manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis.

At week 16, a statistically significantly greater proportion of patients treated with apremilast monotherapy achieved a modified ACR20 (the study’s primary endpoint) versus placebo: 29.2% (apremilast 20 mg; P=0.0076) and 32.3% (apremilast 30 mg; P=0.0011) versus 16.9% (placebo). For those patients randomized to apremilast and completing 52 weeks of the study, an ACR20 response of 53.4% (apremilast 20 mg) and 58.7% (apremilast 30 mg) at week 52 was observed. ACR 50 and 70 was reached by 31.9% and 18.1% of patients, respectively, for apremilast 30 mg.

“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naïve psoriatic arthritis patients,” said Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, US. “These encouraging results suggest that apremilast may have the potential to be used alone and as a first-line therapy.”

Durable improvements in multiple endpoints—including enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (swelling of a finger or toe), impaired physical function as assessed by HAQ-DI, swollen and tender joint counts and associated skin psoriasis—were maintained or increased in patients completing 52 weeks of treatment.

1 of 4

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 16,457.66 -105.64 -0.64%
S&P 500 1,917.35 -13.32 -0.69%
NASDAQ 4,327.1130 -42.66 -0.98%

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