Apremilast: A Review in Oral Ulcers of Behçet’s Disease
Compliance with Ethical Standards
Disclosure: The preparation of this review was not supported by any external funding.
Conflicts of interest: Emma Deeks is a salaried employees of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found here
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.