This Day On The Street
Continue to site
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

Oral Apremilast Demonstrated Clinically Meaningful And Statistically Significant Improvements In Enthesitis And Dactylitis

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced research findings on apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), based on pooled data analyses from three randomized, controlled, phase III trials in psoriatic arthritis—PALACE 1, 2 and 3—at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.

Pre-specified analyses from PALACE 1, 2 and 3 pooled data demonstrated that treatment with apremilast in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic disease, resulted in statistically significant and clinically meaningful improvements in enthesitis and dactylitis scores. At week 24, mean change from baseline in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) reached statistical significance for apremilast 30 mg twice daily (BID; -1.4 vs. -0.8 for placebo; p=0.0159), but not for apremilast 20 mg BID (-1.2; P=NS). At week 24, mean changes from baseline in dactylitis count (a count of fingers and toes with dactylitis) were -1.5 ( P=NS) for apremilast 20 mg BID and -1.8 ( P=0.0121) for apremilast 30 mg BID, versus -1.2 for placebo.

For those patients randomized to apremilast and completing 52 weeks of the study, the median percent change from baseline in MASES and dactylitis count were -66.7% and -100% for both apremilast treatment arms, respectively.

“Psoriatic arthritis is a serious, painful arthritic condition with signs and symptoms that can make day-to-day activities difficult and impede quality of life for many patients,” said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. “Data from these pooled phase III trials showed that apremilast treatment significantly controlled multiple manifestations of psoriatic arthritis and suggest apremilast may provide patients who are living with painful, persistent signs and symptoms of the disease with a new long-term treatment option.”

Patients treated with apremilast achieved significant reduction in number of swollen and tender joints after 16 weeks, which was maintained over 52 weeks.

A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints and places where tendons and ligaments connect to bone, which can be potentially disabling if untreated. Results from all three of the PALACE studies (PALACE 1, 2 and 3) demonstrated that the number of swollen joints and the number of tender joints were both significantly reduced in patients with psoriatic arthritis who were treated with apremilast for 16 weeks compared with placebo.

1 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 17,596.35 -350.33 -1.95%
S&P 500 2,057.64 -43.85 -2.09%
NASDAQ 4,958.4680 -122.0370 -2.40%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs