The oral phosphodiesterase 4 inhibitor apremilast (Otezla®) is indicated for the treatment of oral ulcers associated with Behçet’s disease in some countries, including the USA (where it is the first agent approved for the disease) and Japan. In phase 2 and 3 trials in adults with this chronic and debilitating disorder, 12 weeks of treatment with apremilast 30 mg twice daily reduced the number and pain of oral ulcers and disease activity relative to placebo, with these clinical benefits being accompanied by improvements in health-related quality of life (HR-QOL). Benefits of apremilast were seen regardless of baseline patient/disease characteristics and in Japanese patients, and were sustained over up to 64 weeks of treatment. Apremilast was generally well tolerated, with gastrointestinal adverse events being among the most common tolerability issues. Emerging real-world data also support the drug’s use in this setting. Thus, for patients with oral ulcers associated with Behçet’s disease, apremilast provides an effective and generally well tolerated approved treatment option.
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During the peer review process, the marketing authorization holder of apremilast was also offered the opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
The preparation of this review was not supported by any external funding.
Conflict of interest
Emma Deeks is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11435352.
The manuscript was reviewed by: V. Hamuryudan, Division of Rheumatology, Department of Internal Medicine, Cerrahpasa Medical School, University of Istanbul-Cerrahpasa, Istanbul, Turkey; Y. Kirino, Department of Stem Cell and Immune Regulation, Yokohama City University Graduate School of Medicine, Yokohama, Japan.