Efficacy and safety of apremilast for 3 months in Behçet's disease: A prospective observational study.

Objective: To determine the real-world short-term efficacy and safety of apremilast for Behçet's disease (BD).
Methods: The study included patients who received apremilast for refractory oral ulcers in addition to meeting International Study Group criteria for BD or the revised International Criteria for Behçet's Disease. To assess the efficacy of apremilast, Behçet's disease current activity form (BDCAF) and patients' self-perception of their disease activity were monitored for three months. The disease phenotypes, laboratory data, concomitant medication use, and adverse events were also investigated.
Results: Fourteen BD patients were included in the study. Concomitant drug use were as follows: colchicine 92.9%, prednisolone 21.4%, immunosuppressants 28.6%, and tumor-necrosis inhibitor 14.3%. Oral ulcers and BDCAF scores at 3 months showed significant improvement compared to baseline. Adverse events during the study were diarrhea ( n  = 3, 21.4%), nausea ( n  = 3, 21.4%), music hallucination ( n  = 1, 7.1%), and branch retinal vein occlusion ( n  = 1, 7.1%). Apremilast was discontinued in 1 patient (7.1%) due to nausea.
Conclusion: Significant improvement in oral ulcer and BDCAF with apremilast was confirmed in real-world BD patients after 3 months. The combination of colchicine and apremilast appears to be well tolerated in BD in the short-term.