Celgene International Sàrl, a wholly-owned subsidiary of
Long-term results presented from PALACE 1 revealed meaningful
“I am excited that results from the first long-term PALACE data were
selected for inclusion at the EULAR press conference,” stated Dr.
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
About PALACE Program
PALACE 1, 2, 3 & 4 are four pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 & 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically-appearing placebo for 24 weeks, with a subsequent extension in which all patients are treated with apremilast. The three PALACE studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with DMARD, biologic DMARD, as well as patients who had previously failed a TNF blocker. PALACE-3 includes a subset of 270 patients with significant skin involvement with psoriasis.
The primary endpoint of the PALACE 1, 2 & 3 studies is the proportion of
patients in each treatment group who achieved the
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically-appearing placebo for 24 weeks, with a subsequent extension in which all patients are treated with apremilast.
Taken together, the PALACE program includes the most comprehensive
psoriatic arthritis studies to date intended for regulatory submission.
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates a network of pro-inflammatory and anti-inflammatory mediators. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease
associated with the skin condition psoriasis. More than a million people
in the U.S. and
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Source: Celgene International Sàrl