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Trial of apremilast for oral ulcers in Behçet syndrome

New England Journal of Medicine Nov 21, 2019

Hatemi G, Mahr A, Ishigatsubo Y, et al. - In a phase 3 trial, 207 individuals who had Behçet syndrome with active oral ulcers although no significant organ involvement were randomized to receive either apremilast at a dose of 30 mg (n = 104) or placebo (n = 103), administered orally, twice daily for 12 weeks, followed by a 52-week extension phase in order to determine the efficiency and safety of apremilast in persons with Behçet syndrome who had active oral ulcers and had not formerly received biologic agents. In individuals with oral ulcers related to Behçet syndrome, compared with placebo, apremilast led to a greater decrease in the number of oral ulcers however it was related to adverse events, such as diarrhea, nausea, and headache.
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