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 Achieves Statistical Significance For The Primary Endpoint Of ACR20 In The First Phase III Study (PALACE-1) In Patients With Psoriatic Arthritis

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today presented the results from PALACE-1, the Company’s first Phase III study in psoriatic arthritis, at the American College of Rheumatology annual meeting in Washington, D.C.

The company previously announced statistical significance for the primary endpoint of ACR20 for patients receiving apremilast in the PALACE-1 study, the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs. PALACE-1 is the first phase III study demonstrating statistical significance in a psoriatic arthritis patient population that included both prior biologic exposure (23.6%) and biologic failures (9.3%).

In the study, apremilast demonstrated statistically significant and higher ACR20 responses at week 16 in patients receiving either apremilast 20 or 30 mg BID monotherapy (31.5% and 50.8% respectively vs. 10.5% for placebo; P<0.05 and P≤0.0001), with no meaningful advantage to adding oral DMARDs to apremilast. A higher ACR20 response at week 16 was also demonstrated in biologic-naïve subjects receiving apremilast 30 mg BID monotherapy compared with placebo (59% vs. 12%; P<0.005).

“The results of this first phase III trial of apremilast are encouraging for both physicians and patients as a potentially effective and safe oral therapy for psoriatic arthritis patients,” said Arthur F. Kavanaugh, M.D., Professor of Clinical Medicine at the University of California, San Diego and Director of the Center for Innovative Therapy at the University.

Across the entire study population, statistically significant changes in reducing signs and symptoms of PsA, as measured by the primary endpoint of ACR20 at week 16, were achieved for patients receiving apremilast 30 mg BID vs. placebo (41.01% vs. 19.4%; P≤0.0001). This was further supported by a robust and consistent response (P≤0.0001) across all arthritis-related secondary endpoints, including ACR50, ACR70, DAS-28, good or moderate EULAR response achievement and CDAI at week 24. Statistically significant results were also demonstrated in measures of physical function (HAQ-DI, SF-36 physical function domain score) at week 16 (P=0.0015 and P=0.0049 respectively) and these results were maintained at week 24.

1 of 4

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 18,040.37 +29.69 0.16%
S&P 500 2,111.73 +4.34 0.21%
NASDAQ 5,082.9290 +12.9030 0.25%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs