Real-world effectiveness of apremilast in multirefractory mucosal involvement of Beh?et’s disease

摘要

Relapsing oral and genital ulcers (OGUs) represent the stigmata of Beh?et’s disease (BD) and may be very painful, affecting both quality of life and relationships. A wide number of topical and immunosuppressive drugs can be used to treat ulcers, but failures are commonly reported. The efficacy of the phosphodiesterase-4 inhibitor apremilast has been proven in OGUs of BD in two randomised clinical trials (RCTs), whereas only two case reports are available until now. We aimed at evaluating the real-world effectiveness of apremilast in BD patients with OGUs refractory to conventional and/or biological treatments. We retrospectively evaluated patients classified as BD, according to International Criteria for BD6 and International Study Group7 criteria, who underwent apremilast (30?mg two times per day) for multirefractory OGUs from November 2017 to January 2019. The number of OGUs was assessed at baseline and either at 3 and 6 months. Pain from ulcers and BD activity were evaluated via 100?mm visual analogue scale (VAS) and BD current activity form (BDCAF). We also recorded the number of OGU flares both in the 4 weeks prior to apremilast start and throughout the observation period (table 1 and online supplementary table 2). The occurrence of adverse events was also reported. Paired t-test or Wilcoxon matched-pair signed rank test were used for statistical analysis. The off-label use of apremilast was approved by the Hospital Ethics Committee in compliance with the Declaration of Helsinki. All patients provided a written informed consent.