A review of clinical trials of biologic agents and small molecules for psoriasis in Asian subjects
Journal
Giornale Italiano di Dermatologia e Venereologia
Journal Volume
151
Journal Issue
4
Pages
412-431
Date Issued
2016
Author(s)
Tsai Y.-C.
Abstract
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, eficacy, 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, inliximab, 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 eficacy 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 inliximab 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. ? 2015 Edizioni Minerva Medica.
Subjects
Adalimumab; Asia; Etanercept; Inliximab; Psoriasis; Ustekinumab
SDGs
Other Subjects
adalimumab; antipsoriasis agent; apremilast; biosimilar agent; brodalumab; etanercept; guselkumab; infliximab; ixekizumab; secukinumab; tofacitinib; ustekinumab; biological factor; dermatological agent; immunologic factor; Asian; clinical trial (topic); controlled clinical trial (topic); disease duration; drug efficacy; drug safety; drug synthesis; human; immunogenicity; Medline; multicenter study (topic); phase 2 clinical trial (topic); phase 3 clinical trial (topic); phase 4 clinical trial (topic); psoriasis; psoriatic arthritis; randomized controlled trial (topic); Review; systematic review (topic); Asian continental ancestry group; body weight; pathology; psoriasis; psoriatic arthritis; severity of illness index; Arthritis, Psoriatic; Asian Continental Ancestry Group; Biological Factors; Body Weight; Dermatologic Agents; Humans; Immunologic Factors; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index
Publisher
Edizioni Minerva Medica
Type
review