Apremilast Effective for Oral Ulcers in Behçet's Syndrome
Reduction in number of oral ulcers per patient; greater decline in pain from ulcers with apremilast
FRIDAY, April 17, 2015 (HealthDay News) -- For patients with Behçet's syndrome, the oral phosphodiesterase-4 inhibitor apremilast is effective for treating oral ulcers, according to a study published in the April 16 issue of the New England Journal of Medicine.
Gulen Hatemi, M.D., from Istanbul University Cerrahpasa Medical School, and colleagues conducted a phase 2 multicenter trial involving 111 patients with Behçet's syndrome with two or more oral ulcers. Patients were randomized to apremilast twice daily or placebo for 12 weeks. The regimen was followed by a 12-week extension phase in which the placebo group was switched to apremilast and an observational follow-up phase for 28 days post-treatment.
The researchers found that at week 12 the mean number of oral ulcers per patient was significantly lower in the apremilast group versus the placebo group (0.5 ± 1 versus 2.1 ± 2.6). From baseline to week 12, the mean decline in pain from oral ulcers was greater in the apremilast versus the placebo group (−44.7 ± 24.3 mm versus −16 ± 32.5 mm). The apremilast group had more incidents of nausea, vomiting, and diarrhea than the placebo group. Two severe adverse events were observed in patients receiving apremilast.
"Apremilast was effective in treating oral ulcers, which are the cardinal manifestation of Behçet's syndrome," the authors write.
The study was funded by Celgene, the manufacturer of apremilast.