Long-Term Data Encouraging for Apremilast
Data from PALACE 4 demonstrated clinically meaningful improvements in enthesitis, dactylitis and physical function with apremilast (Otezla, Celgene Corp) that were sustained up to 52 weeks of treatment. Apremilast, approved by the FDA in March 2014, is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).
The findings showed that treatment with apremilast monotherapy in patients with preexisting enthesitis or dactylitis, 2 key manifestations of PsA, resulted in long-term improvements. At week 52, median Maastricht Ankylosing Spondylitis Enthesitis Score decreased by 75% and 45.9% of patients receiving apremilast 30 mg twice a day achieved a score of 0, indicating no pain at any of the enthesitis sites assessed. In addition, apremilast resulted in a median 100% decrease in dactylitis count. A dacylitis count of 0 was achieved by 68.8% of patients.
A physical function analysis found that patients who were treated with apremilast monotherapy continuously for 52 weeks demonstrated improvements at week 16 in the Health Assessment Questionnaire-Disability Index and improvements were sustained up to 52 weeks.
Long-term, 52-week safety results from PALACE 4 identified no new safety findings for apremilast compared with previously reported 24-week safety results. The majority of adverse events (AEs) were mild or moderate in severity and led to a low rate of discontinuation (5.2% in all patients exposed to apremilast). The most commonly reported AEs were nausea, diarrhea, headache and upper respiratory tract infection.
PALACE 4 was a phase III, multicenter, double-blind, placebo-controlled, parallel-group studies with 2 active treatment groups. More than 500 disease-modifying antirheumatic drug-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg, 30 mg or placebo twice daily for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients were treated with apremilast.
Oral Otezla (apremilast) monotherapy showed long-term clinical benefits in DMARD-naïve patients with active psoriatic arthritis [news release]. Boudry, Switzerland. Celgene International; June 11, 2014. http://ir.celgene.com/releasedetail.cfm?ReleaseID=854043. Accessed July 9, 2014.