Oral Apremilast for the Treatment of Plaque Psoriasis

This article provides an update on the use of oral apremilast, a phosphodiesterase-4 (PDE4) inhibitor, for the treatment of plaque psoriasis. Emphasis is placed on safety evaluations, although efficacy considerations are also addressed. Both two-year and three -year data analyses support the favorable safety profile reported in pivotal trials with this agent. Although effective in many study subjects despite baseline characteristics, higher response rates were noted in those with a baseline psoriasis area and severity index (PASI) score <20 and in subjects not previously treated with systemic therapy for psoriasis. Gastrointestinal (GI) side effects are the most common adverse events (AEs) reported, especially during the first few weeks of use; recommendations on management of GI AEs are discussed. Psychological AEs appear to be rare, including with prolonged durations of use, and are not clearly associated with the drug itself as depression and suicidal behaviors are common in individuals with psoriasis. Data reported through up to 182 weeks of exposure to apremilast do not support an association with cardiac AEs, emergence of malignancies, enhanced predilection to develop significant opportunistic infections, or reactivation of occult infection, such as tuberculosis.