Celgene (CELG) Presents Data from OTEZLA Phase 3b; Says Primary Endpoint Met
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Celgene Corporation (Nasdaq: CELG) announced findings from the ACTIVE phase 3b clinical trial of OTEZLA® (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), at the 2016 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Washington, D.C. The trial met its primary endpoint of significant improvement in the proportion of patients achieving an ACR20 response at week 16 with OTEZLA versus placebo in patients with active psoriatic arthritis who have not previously been treated with a biologic therapy.
The ACTIVE trial randomized 219 patients who may have had one prior conventional therapy and were not previously treated with a biologic to either OTEZLA 30 mg twice daily (n=110) or placebo (n=109). An objective of the study was to determine the clinical effects of OTEZLA compared with placebo, by examining efficacy outcomes at earlier time points than in previous studies.
“These findings show a separation from placebo as early as two weeks with oral OTEZLA in patients with psoriatic arthritis who have not been previously treated with biologics,” said Dr. Jacob Aelion, director of the West Tennessee Research Institute and clinical professor of Medicine/Rheumatology at the University of Tennessee in Memphis. “Early responses at week 2 across several measures of disease activity, including morning stiffness and enthesitis, were also seen at week 16.”
A separation between OTEZLA and placebo was seen at week 2, the study’s first efficacy assessment time point, with 16.4 percent of patients in the OTEZLA arm achieving ACR20, compared with 6.4 percent in the placebo arm. Improvements versus placebo were also 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 percent vs. 21.1 percent], and enthesitis (inflammation at sites where tendons or ligaments insert into bone), as measured by a change in Gladman Enthesitis Index (GEI) [−1.1 vs. −0.4]. A trend to decrease in swollen joint count was also observed in patients receiving OTEZLA compared with those on placebo (−27.7 percent for OTEZLA vs. −17.5 percent for placebo).
At week 16, 38.2 percent of patients in the OTEZLA arm achieved an ACR20 response, compared with 20.2 percent in the placebo arm. Improvements were also seen at week 16 in other measures of disease, including: 28-joint count Disease Activity Score (C-reactive protein) (−1.07 with OTEZLA vs. −0.39 with placebo), swollen joint count (−46.4 percent vs. 4.2 percent, respectively), HAQ-DI (−0.21 vs. −0.06), improvement in morning stiffness severity (46.4 percent vs. 25.7 percent), and enthesitis (−1.5 vs. −0.4).
At week 24, placebo patients crossed over to active treatment with OTEZLA. Responses demonstrated in the placebo-controlled phase were maintained through week 52. For patients who were on OTEZLA from baseline, ACR20, ACR50, and ACR70 response rates at week 52 were 67.1 percent, 36.7 percent and 21.3 percent, respectively, and observed percent change in swollen joint count was −77.5 percent. Among patients who had enthesitis at baseline, GEI of 0 was 69.8 percent.
The most commonly reported adverse events during the placebo-controlled period were nasopharyngitis (8.3 percent with OTEZLA vs. 6.4 percent with placebo), nausea (8.3 percent vs. 1.8 percent, respectively), headache (7.3 percent vs. 3.7 percent), hypertension (6.4 percent vs. 6.4 percent), diarrhea (14.7 percent vs. 11.0 percent) and upper respiratory tract infection (4.6 percent vs. 10.1 percent). Serious adverse events in the OTEZLA and placebo arms were 2.8 percent and 4.6 percent, respectively. No increase in adverse event incidence or severity was seen through week 52.
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