Real‐world use of apremilast for patients with psoriasis in Japan

Abstract

Apremilast is a novel oral phosphodiesterase 4 inhibitor effective for psoriasis. It regulates the production of pro-inflammatory mediators. Apremilast was approved in December 2016 in Japan; however, its efficacy and safety in a real-world setting among Japanese patients have not been reported. We report on 44 patients treated with apremilast between March and October 2017. The median treatment duration was 25 weeks (range, 2-33). Thirty-five patients (79.5%) continued the drug for at least 23 weeks, and five (11.4%) achieved a Psoriasis Area and Severity Index 100 response within 12 weeks. Nine patients discontinued the drug within 24 weeks mainly due to insufficient efficacy (n = 3) and adverse events (n = 4). Seven patients continued their previous systemic therapies such as cyclosporin (n = 1), methotrexate (n = 1), etretinate + methotrexate (n = 1) and biologics (n = 4) combined with apremilast. Of these patients, 55.9% had at least one adverse event although no severe adverse events. The most common adverse event was diarrhea (31.8%), followed by nausea (25.0%), headache (13.6%), abdominal discomfort (6.8%) and vomiting (6.8%). The proportion of diarrhea in our patients was higher than those of previous clinical trials. Among 10 patients with psoriatic arthritis, apremilast did not improve joint pain in nine (90%). To investigate the relationship between treatment efficacy and plaque size, we defined a small plaque as an individual rash diameter of 1 inch or less. The efficacy of apremilast was greater in patients with small plaques than in patients with large plaques.

Real‐world experiences of apremilast in clinics for Japanese patients with psoriasis

“…The most common event was loose stools or diarrhea; its rate was 37%, was similar to previous studies (31.8% by Kishimoto et al. , 37% by Mayba et al. , 43.8% by Vujic et al. )…”

“…This was not much different from the numbers reported in previous studies (55.6% by Kishimoto et al. , 61.7% by Mayba et al. , 64.6% by Vujic et al.…”

“…In Japan, apremilast was approved in December 2016, and was expected to be a simple and long‐lasting systemic therapeutic agent. Its safety and efficacy were shown in the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2 trials and in several reports in Japan on real‐world patients treated with apremilast . Because of its safety and convenience, apremilast is easy to use, even for small dermatology clinics; and because clinics are easy to consult, they draw patients who are busy or have only mild symptoms, and consequently low visit and treatment adherence, reflecting realistic conditions.…”

The CCL20 and CCR6 axis in psoriasis

“…In addition, the CCL20/CCR6 chemotactic system is critically involved in the maintenance of the TNF‐α/IL‐23/IL‐17A axis. Therapeutic agents for psoriasis include topical steroids, topical vitamin D3 derivatives, phototherapy, phosphodiesterase‐4 inhibitors, cyclosporine, methotrexate and biologics targeting TNF‐α, IL‐23 and IL‐17A . As the TNF‐α/IL‐23/IL‐17A axis plays a pivotal role in the pathogenesis of psoriasis, the efficacy of anti–TNF‐α/IL‐23/IL‐17A biologics is excellent …”

Results of a retrospective study on the efficacy and safety of adalimumab 80 mg administrated every other week in patients with psoriasis at a single Japanese institution

“…16 In this study, six out of the seven patients with generalized pustular psoriasis or erythrodermic psoriasis were treated with ADA 80 mg every other week. 18 However, apremilast was used only in two patients. In most patients, topical corticosteroids and vitamin D 3 were used for the treatment of skin lesions.…”