“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
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.
Results from PALACE 1, one of three registrational randomized,
placebo-controlled phase III studies of apremilast in PsA were released
at ACR in
In addition, positive results from two large, pivotal global studies of
apremilast in more than 1,200 patients with moderate-to-severe plaque
psoriasis (ESTEEM 1 and 2) were released in
A randomized, placebo-controlled phase III study (POSTURE) of apremilast
in ankylosing spondylitis (AS) began enrolling patients in
These results are from an investigational phase III study. Apremilast is not approved for the treatment of psoriatic arthritis.
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 4
PALACE 4 is one of four pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with 2 active-treatment groups in a DMARD-naïve patient population. More than 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 primary endpoint of the study is the proportion of patients in each
treatment group who achieved the
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate 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. To learn more go to www.discoverpde4.com/.
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
Celgene International Sàrl, located in Boudry, in the
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results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual Report
on Form 10-K and our other reports filed with the
Source: Celgene International Sàrl