The approval was based on data from the placebo controlled, double blind phase 3 RELIEF study which evaluated the efficacy and safety of apremilast in patients with Behçet’s disease and active oral ulcers who were previously treated with at least 1 nonbiologic agent and were candidates for systemic therapy. Patients were randomized to receive apremilast 30mg twice daily (n=104) or placebo (n=103) for 12 weeks; after 12 weeks, all patients received apremilast 30mg twice daily. The primary end point of the study was clinical response of oral ulcers at Week 12 based on the oral ulcer counts and pain.
Results showed that treatment with apremilast led to a 42.7 point reduction from baseline in the pain of oral ulcers (measured by the visual analog scale) compared with an 18.7 point reduction with placebo. In addition, the proportion of patients achieving oral ulcer complete response (oral ulcer-free) was 52.9% in the apremilast arm vs 22.3% in the placebo arm.
Moreover, 29.8% of patients treated with apremilast achieved oral ulcer complete response by Week 6 and remained oral ulcer-free for at least 6 additional weeks during the 12-week placebo-controlled treatment phase, compared with 4.9% of those in the placebo arm. The daily average number of oral ulcers during the 12-week treatment phase was 1.5 in the apremilast arm and 2.6 in the placebo arm (based on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10 and 12).
With regard to safety, the most common adverse reactions reported in the study included diarrhea, nausea, headache, and upper respiratory infection.
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