WASHINGTON, DC—Data from the Phase 3b ACTIVE clinical trial presented at the 2016 ACR/ARHP Annual Meeting showed that Otezla (apremilast; Celgene) met its primary endpoint of significant improvement in the proportion of patients achieving an ACR20 response at Week 16 vs. placebo in patients with active psoriatic arthritis who were not previously treated with biologics.
The ACTIVE trial (n=219) randomized patients who have had 1 prior conventional therapy and were not previously treated with biologic therapy to receive either Otezla 30mg twice daily or placebo. The study’s objective was to determine the clinical effects of Otezla vs. placebo through its efficacy outcomes at earlier time points than in previous studies.
Dr. Jacob Aelion, director of the West Tennessee Research Institute and clinical professor at the University of Tennessee in Memphis, explained, “Early responses at Week 2 across several measures of disease activity, including morning stiffness and enthesitis, were also seen at Week 16.”
At Week 2, 16.4% of patients in the Otezla group achieved ACR20 vs. 6.4% in the placebo group. In addition, improvements compared to placebo were seen at Week 2 in 28-joint count Disease Activity Score (C-reactive protein) [-0.59 vs. -0.31, respectively], health assessment questionnaire disability index (HAQ-DI) [-0.13 vs. -0.05], morning stiffness severity [42.7% vs. 21.1%], and enthesitis, as measured by a change in Gladman Enthesitis Index (GEI) [-1.1 vs. -0.4].
A decrease in swollen joint count was also seen in patients receiving Otezla vs. patients in the placebo group (-27.7% vs. -17.5%).
At Week 16, more patients in the Otezla group achieved an ACR20 response vs. the placebo group (38.2% vs. 20.2%). Improvements in other disease outcome measures including 28-joint count Disease Activity Score (C-reactive protein), swollen joint count, HAQ-DI, improvement in morning stiffness severity, and enthesitis were seen in the Otezla arm.
At Week 24, patients in the placebo group crossed over to active treatment with Otezla. The responses seen in the placebo-controlled phase were sustained through Week 52, reported Dr. Aelion. Patients who were on Otezla from baseline had an ACR20 response rate at 67.1%, ACR50 response rate of 36.7%, and ACR70 response rate of 21.3%, respectively, at Week 52.
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate, is indicated for the treatment of adults with active psoriatic arthritis.