Background: Real-world data differ from clinical trial data. Although some real-world data regarding apremilast use for psoriasis treatment has been reported in Western countries, no such data has been reported in Asian countries. Objective: To study the efficacy, including Psoriasis Area and Severity Index (PASI) and drug survival, and safety of apremilast in Japanese patients with psoriasis. Methods: Data on all the patients treated with apremilast in Kurume University Hospital between May 2017 and June 2018 were retrieved, with June 30 2018, as the data lock date. Efficacy was analyzed by PASI50, PASI75, and PASI90; drug survival by Kaplan-Meier analysis; and drug safety by the proportion of adverse events (AEs). Results: Fourteen of 42 (33.3%) patients achieved PASI75/90; 16 (32%) patients had discontinued apremilast by the data lock date. Drug survival at week 28 was 70%. No serious AEs were reported; the most prevalent one was loose stools/diarrhea (60%), followed by nausea (38%). The most common reason for apremilast discontinuation was primary/secondary failure. Conclusions: Apremilast is safe and effective in Japanese patients with psoriasis. Higher occurrence of loose stools/diarrhea was noted in our cohort than that reported in Western real-world studies on apremilast.
Background: Real-world data differ from clinical trial data. Although some real-world data regarding apremilast use for psoriasis treatment has been reported in Western countries, no such data has been reported in Asian countries. Objective: To study the efficacy, including Psoriasis Area and Severity Index (PASI) and drug survival, and safety of apremilast in Japanese patients with psoriasis. Methods: Data on all the patients treated with apremilast in Kurume University Hospital between May 2017 and June 2018 were retrieved, with June 30 2018, as the data lock date. Efficacy was analyzed by PASI50, PASI75, and PASI90; drug survival by Kaplan-Meier analysis; and drug safety by the proportion of adverse events (AEs). Results: Fourteen of 42 (33.3%) patients achieved PASI75/90; 16 (32%) patients had discontinued apremilast by the data lock date. Drug survival at week 28 was 70%. No serious AEs were reported; the most prevalent one was loose stools/diarrhea (60%), followed by nausea (38%). The most common reason for apremilast discontinuation was primary/secondary failure. Conclusions: Apremilast is safe and effective in Japanese patients with psoriasis. Higher occurrence of loose stools/diarrhea was noted in our cohort than that reported in Western real-world studies on apremilast.
Entities:
Keywords:
Apremilast; Japan; drug survival; psoriasis
Authors: Thomas Graier; Wolfgang Weger; Paul-Gunther Sator; Wolfgang Salmhofer; Barbara Gruber; Constanze Jonak; Claudia Kölli; Martina Schütz-Bergmayr; Igor Vujic; Gudrun Ratzinger; Nina Häring; Clemens Painsi; Knut Prillinger; Alexander Mlynek; Hans Skvara; Hannes Trattner; Adrian Tanew; Roland Lichem; Christina Ellersdorfer; Franz Legat; Alexandra Gruber-Wackernagel; Angelika Hofer; Erich Schmiedberger; Wolfram Hoetzenecker; Robert Müllegger; Werner Saxinger; Franz Quehenberger; Peter Wolf Journal: JAAD Int Date: 2020-12-26
Authors: Fabiola Atzeni; Elisabetta Gerratana; Ignazio Francesco Masala; Sara Bongiovanni; Piercarlo Sarzi-Puttini; Javier Rodríguez-Carrio Journal: Front Med (Lausanne) Date: 2021-08-30