Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced results from PALACE 3, the Company's third phase III study in psoriatic arthritis (PsA), at EULAR, the European Congress of Rheumatology annual meeting in Madrid, Spain.
The PALACE 3 study, which evaluated 495 patients, demonstrated statistical significance in achieving the primary endpoint of American College of Rheumatology (ACR) 20 score at week 16 for patients receiving apremilast compared to placebo (PBO), (PBO, 19%; apremilast 20 mg BID, 29%; apremilast 30 mg BID, 43%; p<0.05 and p≤0.0001, respectively). PALACE 3 is the third pivotal phase III, randomized, placebo-controlled study evaluating Celgene's novel, oral small-molecule inhibitor of phophodiesterase 4 (PDE4) in patients with active psoriatic arthritis who had previously received and/or failed an oral disease-modifying anti-rheumatic drug (DMARD) and/or biologic therapy. In this study, apremilast treatment was used alone or in combination with oral DMARDs. By design, PALACE 3 includes a subset of 270 patients with significant active psoriatic skin involvement.
Patients in the 30 mg BID active treatment arm also demonstrated significant and sustained improvements in psoriasis-related endpoints, including Psoriasis Area Severity Index (PASI) 50 and PASI-75 at week 24. Similar improvements in 30 mg BID-treated patients were also observed in key secondary endpoints, including various measures of physical function, signs and symptoms and quality of life.
The safety and tolerability profile of apremilast in PALACE 3 was consistent with other previously reported phase III studies of the therapy in psoriatic arthritis.
Apremilast Pooled Safety Analysis Presented
The company also presented results from a pooled safety data analysis encompassing multiple randomized controlled phase III studies, PALACE 1, 2 & 3.
In the 24-week placebo-controlled analysis, which included nearly 1,500 patients from the three phase III studies, the most common AEs (≥5%) were diarrhea, nausea, headache and URTI. The majority of AEs (93-96%) were mild or moderate in severity, with discontinuation rates due to AEs (PBO, 4.2%; apremilast 20 mg BID, 5.6%; apremilast 30 mg BID, 7.2%). Serious AEs occurred in 3.8%, 3.4% and 3.8% of PBO, apremilast 20 mg BID and apremilast 30 mg BID, respectively. Importantly, there were no safety signals with respect to major cardiac events, malignancies, including lymphoma or systemic opportunistic infections, and no cases of reactivations of tuberculosis.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The NDA/NDS submissions, based on the combined data from PALACE 1, 2 & 3 for PsA, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. The Company previously announced it expects to file a separate NDA/NDS in the US and Canada for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.