Health Boards
Tue-07-05-2013, 10:39 AM
UPDATE:
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis. This is the first Company-sponsored trial studying patients who had not previously received an oral disease-modifying antirheumatic drug (DMARD).
“Despite recent advances in the treatment of psoriatic arthritis, there remains a significant need for more oral DMARD treatment options for DMARD-naïve patients,” said Randall Stevens, VP of Clinical Research and Development for Inflammation & Immunology. “PALACE-4 is now the fourth major randomized apremilast Phase III study to provide promising results for patients with psoriatic arthritis.”
Patients on apremilast also achieved a statistically significant benefit over placebo in key secondary endpoints, as demonstrated in various measures of physical function and signs and symptoms, including enthesitis.
No new safety and tolerability signals identified, with fewer AEs and SAEs reported than in PALACE 1, 2&3. Importantly, in PALACE 4, no systemic opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. The most common AEs in PALACE 4 (≥5%) were nausea, diarrhea and headache.
The PALACE 4 study is ongoing and the study extension remains blinded until all patients complete week 52. Full data from this phase III study will be submitted for presentation at appropriate medical meetings.
Source: NO LINKS ALLOWED
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis. This is the first Company-sponsored trial studying patients who had not previously received an oral disease-modifying antirheumatic drug (DMARD).
“Despite recent advances in the treatment of psoriatic arthritis, there remains a significant need for more oral DMARD treatment options for DMARD-naïve patients,” said Randall Stevens, VP of Clinical Research and Development for Inflammation & Immunology. “PALACE-4 is now the fourth major randomized apremilast Phase III study to provide promising results for patients with psoriatic arthritis.”
Patients on apremilast also achieved a statistically significant benefit over placebo in key secondary endpoints, as demonstrated in various measures of physical function and signs and symptoms, including enthesitis.
No new safety and tolerability signals identified, with fewer AEs and SAEs reported than in PALACE 1, 2&3. Importantly, in PALACE 4, no systemic opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. The most common AEs in PALACE 4 (≥5%) were nausea, diarrhea and headache.
The PALACE 4 study is ongoing and the study extension remains blinded until all patients complete week 52. Full data from this phase III study will be submitted for presentation at appropriate medical meetings.
Source: NO LINKS ALLOWED
