Long-term efficacy and safety of apremilast in the treatment of plaques psoriasis: A real-world, single-center experience.

ABSTRACT

Apremilast is a small molecule approved for the treatment of plaques psoriasis and adult psoriatic arthritis. Pivotal studies have demonstrated short and long term efficacy and safety of apremilast but few data in real life are still available. The aim of this study is to report the efficacy and safety results of apremilast in clinical practice in patients with moderate-to-severe plaque psoriasis, focusing on therapeutic results obtained after 24 and 52 weeks of treatment. From May 2018 to December 2018, 40 patients with plaques psoriasis have been enrolled. Psoriasis Area Severity Index (PASI), body surface area, Physician Global Assessment, and Dermatology Life Quality Index (DLQI) were performed at baseline at 24 (W24) and 52 (W52) weeks after treatment initiation. Primary endpoint was to evaluate the percentage of patient that achieved PASI 75, PASI 90 and PASI 100 at week 24 and 52 of treatment. Additional measure of efficacy was percentage of patients reaching the minimal disease activity (MDA = PGA0/1 and DLQI 0/1) after 24 and 52 weeks of treatment. As secondary endpoint, we evaluated the percentage of patient that achieved DLQI 0-1 at W24 and W52, and long-term safety of apremilast. The percentage of patients who achieved PASI75, PASI90 and PASI100 was 47.5%, 30% and 10% and 25%, 35% and 10% at W24 and W52 respectively. About the half of the reported patients reached MDA at W24 (n = 21) and at W52 (n = 20). The 60% of patients achieved and maintained DLQI 0-1 at W24 until W52. Diarrhea, nausea, headache, insomnia, and other AEs have been reported by 28 patients. Apremilast in real life experience confirmed the levels of efficacy and safety obtained in pivotal trials. In particular, the good initial response to the treatment is predictive of the maintenance or improvement of the outcome over W52. The efficacy is supported by an excellent safety profile even in frail patients.