Health Boards
Wed-14-11-2012, 13:10 PM
UPDATE:
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.
The overall safety profile was consistent with previous experiences in the phase II program. Importantly, no opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. Apremilast was generally well tolerated. The majority of AEs (>95%) were mild or moderate, with serious AEs and discontinuations due to AEs similar across all treatment arms.
An NDA submission to the U.S. Food and Drug Administration, based on the combined PALACE program for PsA, is expected in the first half of 2013. The sNDA submission for psoriasis is expected to follow in the second half of 2013. A combined MAA submission in Europe is also planned for the second half of 2013.
Source: NO LINKS ALLOWED
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.
The overall safety profile was consistent with previous experiences in the phase II program. Importantly, no opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. Apremilast was generally well tolerated. The majority of AEs (>95%) were mild or moderate, with serious AEs and discontinuations due to AEs similar across all treatment arms.
An NDA submission to the U.S. Food and Drug Administration, based on the combined PALACE program for PsA, is expected in the first half of 2013. The sNDA submission for psoriasis is expected to follow in the second half of 2013. A combined MAA submission in Europe is also planned for the second half of 2013.
Source: NO LINKS ALLOWED
