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| Celgene Announces Positive Top Line Data from Randomized Controlled Phase II Study of Apremilast in Psoriatic Arthritis |
The study sought to determine the efficacy and safety of apremilast in 204 patients at two different dose regimens - 20mg twice per day and 40mg once per day - compared to placebo after 12 weeks. In the study, both apremilast treatment arms had a significant improvement in their ACR20 outcome versus placebo: 43.5% of patients in the 20 mg twice daily arm and 35.8% of patients in the 40 mg once daily arm achieved an ACR20 compared to 11.8% of patients in the placebo arm. In addition, the study measured secondary 12-week endpoints including ACR50 and ACR70, defined as the percentage of patients achieving 50% and 70% improvements respectively according to ACR criteria. These measures are utilized to demonstrate clinical benefit for patients in addition to the primary regulatory measure of ACR20. The 12-week ACR50 was 17.4% in the 20mg twice daily arm, 13.4% in the 40 mg once daily arm, and 2.9% in the placebo arm. The 12-week ACR70 was 5.8% in the 20 mg twice daily arm, 7.5% in the 40 mg once daily arm, and 1.5% in the placebo arm. The five most common adverse events reported in the study were nausea, diarrhea, headache, nasopharyngitis and fatigue. Additionally, there was not a significant difference in infections between apremilast and placebo. In the study 9, 6 and 3 percent of patients discontinued treatment due to adverse events while 9, 0 and 18 percent discontinued due to lack of efficacy in the 20 mg twice daily, 40 mg once daily and placebo groups, respectively.
“The positive data from this phase II study are encouraging indicators
of the potential of apremilast as an innovative oral treatment that may
fill a significant unmet need in this debilitating disease,” said
Based on our evaluation of other ongoing trials, In addition to the planned psoriatic arthritis pivotal program, a phase III study of apremilast in moderate-to-severe plaque-type psoriasis is anticipated to begin in 2010, pending the results of the phase IIb trial. Apremilast is also currently being investigated in a phase II study in recalcitrant plaque-type psoriasis with data expected in the first quarter of 2010. A number of investigator-initiated trials are ongoing in cutaneous lupus, prurigo nodularis, ankylosing spondylitis, erosive osteoarthritis, cutaneous sarcoidosis and a number of other inflammatory conditions. About Apremilast Apremilast is a novel, orally available small molecule compound that exhibits anti-inflammatory activities through the suppression of multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 & 23, and interferon-gamma among others. Apremilast is the lead investigational anti-inflammatory compound in the Celgene Inflammation Franchise, and is in phase II clinical development for the treatment of psoriasis, psoriatic arthritis and in proof of concept trials in other inflammatory diseases. About Psoriatic Arthritis
Psoriatic arthritis is a type of inflammatory arthritis that affects
more than a million people in the U.S. and
About
This release contains certain forward-looking statements which
involve known and unknown risks, delays, uncertainties and other factors
not under the Company's control, which may cause actual results,
performance or achievements of the Company to be materially different
from the results, performance or other expectations implied by these
forward-looking statements. These factors include results of current or
pending research and development activities, actions by the Source:
Celgene Corporation |