250. IMPROVEMENTS IN QUALITY OF LIFE IN BEHÇET’S SYNDROME PATIENTS TREATED WITH APREMILAST: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Abstract

Background: Behçet's syndrome is a chronic, multi-system inflammatory disorder characterized by painful, recurrent oral ulcers (OU) that can impair quality of life (QoL). Apremilast (APR), an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in the treatment of OU of Behçet's syndrome in a phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled study (RELIEF). SkMip ttoh Moadins: C Ao ntotetnatl of 207 patients were randomized (1:1) to APR 30 mg BID or PBO BID for a 12-week PBO-controlled phase, followed by a 52-week active treatment extension. Eligible patients were >18 years old, had active Behçet's syndrome, with >3 OU at randomization or > 2 OU at screening and randomization, and without active major organ involvement. The primary efficacy endpoint was area under the curve for the number of OU through 12 weeks (AUCWk0-12). Clinical improvement of OU was evaluated by assessments of OU pain (100-mm VAS) and measures of disease activity and QoL. Disease activity measures included the Behçet's Syndrome Activity Score (BSAS) and Behçet's Disease Current Activity Index Form (BDCAF). QoL assessments included the Behçet's Disease QoL (BDQoL) and the 36-item Short-Form Health Survey version 2 (SF-36v2), consisting of Physical and Mental Component Summary (PCS and MCS) scores and Physical Functioning domain (PF) score. An analysis of covariance model was used to analyze the primary endpoint and change from baseline at Week 12 in BDQoL score and SF-36v2 PCS, MCS, and PF scores. Results: The primary efficacy endpoint of AUCWk0-12 for the number of OU was significantly lower with APR vs PBO (P < 0.0001). Significant improvements were observed with APR vs PBO in the mean change from baseline at Week 12 in BDQoL score (P = 0.0003), which was supported by significant improvements in the mean change from baseline at Week 12 in SF-36v2 PCS (P = 0.0204), MCS (P < 0.0001), and PF (P = 0.0060) scores in APR vs PBO patients. In all of the SF- 36v2 subscale scores, a 10% to 25% greater proportion of patients receiving APR vs PBO experienced an improvement of at least 2.5 points (minimal clinically important difference) at Week 12. Conclusion: APR demonstrated significant reductions in OU through Week 12 and clinically meaningful improvements in Behçet's syndrome-related and overall health-related QoL, including physical and mental function.