Arvin Ighani1, Jorge R Georgakopoulos2, Linda L Zhou3, Scott Walsh4, Neil Shear4, Jensen Yeung4. 1. 1 Faculty of Medicine, University of Toronto, Toronto, ON, Canada. 2. 2 Schulich School of Medicine and Dentistry, Western University, London, ON, Canada. 3. 3 Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. 4. 4 Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada.
Abstract
BACKGROUND: Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. OBJECTIVE: Assess the efficacy and safety of apremilast monotherapy in real-world practice. METHODS: A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a ≥75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting ≥1 AE at 16 weeks. RESULTS: Thirty-four patients were included. EFFICACY: 19 patients (55.9%) achieved PASI-75 or PGA 0/1. SAFETY: 23 patients (67.6%) experienced ≥1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). CONCLUSION: Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study.
BACKGROUND: Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. OBJECTIVE: Assess the efficacy and safety of apremilast monotherapy in real-world practice. METHODS: A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a ≥75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting ≥1 AE at 16 weeks. RESULTS: Thirty-four patients were included. EFFICACY: 19 patients (55.9%) achieved PASI-75 or PGA 0/1. SAFETY: 23 patients (67.6%) experienced ≥1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). CONCLUSION: Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study.
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: J L W Lambert; S Segaert; P D Ghislain; T Hillary; A Nikkels; F Willaert; J Lambert; R Speeckaert Journal: J Eur Acad Dermatol Venereol Date: 2020-08 Impact factor: 6.166