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GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA
A Journal on Dermatology and Sexually Transmitted Diseases
Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,014
Giornale Italiano di Dermatologia e Venereologia 2016 August;151(4):412-31
A review of clinical trials of biologic agents and small molecules for psoriasis in Asian subjects
Ya C. TSAI 1, Tsen F. TSAI 2 ✉
1 Department of Dermatology, Far Eastern Memorial Hospital, New Taipei, Taiwan; 2 Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
INTRODUCTION: Biologics are increasingly used in the treatment of moderate to severe psoriasis. However, most of the pivotal studies were performed mainly in western countries. The purpose of this review article was to compare the differences of clinical trial results between Asian and Western subjects of psoriasis regarding baseline demographics, efficacy, dermatology life quality index, safety and antidrug antibodies.
EVIDENCE ACQUISITION: In this review article, we searched the PubMed/Medline, ClinicalTrials.gov, and posters from main dermatologic meetings.
EVIDENCE SYNTHESIS: Only randomized controlled trial results or trial results for registration purposes of etanercept, adalimumab, infliximab, ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, tofacitinib, and apremilast are included.
CONCLUSIONS: Asian subjects were generally 15-20 Kgs lighter, with fewer psoriatic arthritis, shorter disease duration since diagnosis, and higher baseline severity compared to western subjects. Better efficacy had been found in some studies such as secukinumab, brodalumab, ixekizumab, and tofacitinib in Japanese groups. The safety in Asian trials was generally compatible with the pivotal studies, except for the occurrence of active tuberculosis in the infliximab trial in China. Additional indications of pustular and erythrodermic psoriasis are approved in Japan for some of the agents based on phase II/III studies.