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Oral Apremilast (Otezla) Shows Sustained Clinical Response in Patients With Active Psoriatic Arthritis
Positive results from long-term (104-week) efficacy and safety analyses of apremilast (Otezla, Celgen Corporation) in the open-label phase of two phase III clinical trials have been presented at the 2014 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in Boston.
Apremilast was approved in March 2014 for the treatment of adults with active psoriatic arthritis and in September 2014 for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) that is specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which apremilast exerts its therapeutic action in patients with psoriasis or psoriatic arthritis is not well defined.
In the pivotal PALACE 1 and PALACE 4 studies, the primary endpoint was the modified American College of Rheumatology criteria for 20% improvement (ACR20) at week 16. Secondary endpoints included other measures of signs and symptoms of psoriatic arthritis, physical functioning, and patient-reported outcomes.
In the PALACE 1 trial, 84% (144/171) of patients who completed 1 year (52 weeks) of 30-mg twice-daily therapy continued to receive apremilast at 2 years (104 weeks). Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving apremilast 30 mg twice daily, the ACR20 response rate was 65.3%. ACR50 and ACR70 response rates were 34.0% and 19.6%, respectively, at week 104.
Similar findings were observed in the PALACE 4 trial. In this study, nearly 84% (168/201) of disease-modifying anti-rheumatic drug (DMARD)-naïve patients who completed 1 year of treatment with apremilast 30 mg twice daily monotherapy continued to receive apremilast at 2 years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, ACR50 and ACR70 response was reached by 61.4%, 40.7%, and 19.2% of patients, respectively.
Rates of diarrhea, nausea, headache, and upper respiratory tract infection (URTI) at week 104 in the PALACE 1 and 4 trials, respectively, were as follows: diarrhea (1.8% and 2.0%), nausea (0.6% and 2.0%), headache (4.7% and 1.0%), and URTI (4.7% and 4.5%). Serious AEs occurred in 4.7% and 5.0% of patients, respectively.
Source: Celgene Corporation; November 18, 2014.