Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced 52-week results from PALACE 1, the Company's first phase III study in psoriatic arthritis at the European Congress of Rheumatology (EULAR) annual meeting in Madrid, Spain. The results were included in the EULAR press conference, which highlights data considered representative of highest quality and most meaningful research presented at EULAR. The full PALACE 1 oral presentation will be presented later today. (https://b-com.mci-group.com/AbstractList/EULAR2013.aspx).
Long-term results presented from PALACE 1 revealed meaningful improvements in American College of Rheumatology (ACR) 20 scores from week 24 through week 52. Patients who received apremilast for 52 weeks demonstrated ACR scores of 63% for apremilast 20 mg BID and 55% for apremilast 30 mg BID. Similar improvements over time were observed in the ACR 50 and ACR 70 scores.
"I am excited that results from the first long-term PALACE data were selected for inclusion at the EULAR press conference," stated Dr. Arthur Kavanaugh, Professor of Clinical Medicine and Director of the Center for Innovative Therapy at the University of California, San Diego School of Medicine. "There is a high unmet medical need for additional efficacious, well-tolerated treatment options for patients with psoriatic arthritis."
PALACE 1 is the first completed pivotal phase III, randomized, placebo-controlled study evaluating the Company's 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 2 and PALACE 3 have completed the primary end-point phases and are in long-term follow-up.
The safety and tolerability profile of apremilast during the 52-week period was consistent with what was observed in the placebo-controlled portion of the trial (0-24 weeks) and with what was observed in other PALACE trials to date. 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 were reported for the 52-week period. At week 52, the most common treatment-emergent adverse events (TEAEs) reported (>5%) included nausea, diarrhea, headache, URTI and nasopharyngitis.
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 US and Canada in Q1 2013 and Q2 2013, respectively. The Company previously announced it expects to file a separate NDA/NDS in the US/Canada for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.
SOURCE Celgene International Sàrl