Number of Oral Ulcers in Behçet Syndrome May Decrease With Immunosuppressant

Compared with placebo, apremilast yields a greater reduction in the number of oral ulcers among persons with Behçet syndrome, according to new study findings.

To evaluate the efficacy and safety of the small-molecule phosphodiesterase-4 inhibitor in this patient population, the researchers conducted a phase 3 trial that included 207 participants with Behçet syndrome who had active oral ulcers but no major organ involvement.

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The researchers randomly assigned 104 of the participants to receive apremilast, 30 mg, and 103 of the participants to receive placebo. Both were administered orally, twice daily, for 12 weeks, followed by a 52-week extension phase.

The researchers measured the total number of oral ulcers during the 12-week placebo-controlled period utilizing the area under the curve (AUC)—the lower the value, the fewer ulcers a participant had. The AUC for the number of oral ulcers was 129.5 for apremilast and 222.1 for placebo.

The researchers also assessed the change in the Behçet’s Disease Quality of Life (BDQoL) score from baseline and found that apremilast yielded a greater score improvement. The BDQoL score ranged from 0 to 30, with higher scores indicating greater impairment in quality of life. While the apremilast group had a change of −4.3 points, the placebo group had a change of −1.2 points.

In their safety evaluation, the researchers determined that the adverse events associated with apremilast included diarrhea, nausea, and headache.

—Colleen Murphy

Reference:

Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of apremilast for oral ulcers in Behçet’s syndrome. N Engl J Med. 2019;381(20):1918-1928. doi:10.1056/NEJMoa1816594.