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  1. NTU Scholars
  2. 醫學院
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Please use this identifier to cite or link to this item: https://scholars.lib.ntu.edu.tw/handle/123456789/367745
Title: Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: A phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL)
Authors: TSEN-FANG TSAI
Issue Date: 2011
Journal Volume: 63
Journal Issue: 3
Start page/Pages: 154-163
Source: Journal of Dermatological Science 
Abstract: 
Background: Ustekinumab has been evaluated in Caucasian patients with psoriasis, but no studies have been conducted in Asian patients. Objective: To assess the efficacy and safety of ustekinumab in Taiwanese and Korean patients with moderate-to-severe psoriasis. Methods: In this 36-week, multicenter, double-blind, placebo-controlled study, 121 patients with moderate-to-severe psoriasis were randomized (1:1) to receive subcutaneous injections of ustekinumab 45. mg at weeks 0, 4, 16 or placebo at weeks 0, 4 and ustekinumab 45. mg at weeks 12, 16. Efficacy endpoints at week 12 included the proportion of patients achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75; primary endpoint), proportion of patients with Physician's Global Assessment (PGA) of cleared or minimal, and change from baseline in Dermatology Life Quality Index (DLQI). Results: At week 12, the proportion of patients achieving PASI 75 was 67.2% and 5.0% in the ustekinumab 45. mg and placebo groups, respectively (p< 0.001). PGA of cleared or minimal was achieved by 70.5% (ustekinumab) and 8.3% (placebo; p< 0.001), and median DLQI changes were -11.0 and 0.0, respectively (p< 0.001). Efficacy was maintained through week 28 in ustekinumab-treated patients. Adverse event (AE) profiles at week 12 were similar between the ustekinumab and placebo groups: 65.6% and 70.0%, respectively, had at least one reported AE. Through week 36, no disproportionate increase in AEs was observed, with the exception of abnormal hepatic function, which was related to concomitant isoniazid treatment for latent tuberculosis. Injection-site reactions were rare and mild. No deaths, malignancies, or cardiovascular events were reported. Conclusions: Treatment with subcutaneous ustekinumab 45. mg offers a favorable benefit/risk profile for Taiwanese and Korean patients with moderate-to-severe psoriasis. The efficacy and safety profile is consistent with the global phase III studies of ustekinumab in psoriasis. ? 2011 Japanese Society for Investigative Dermatology.
URI: http://www.scopus.com/inward/record.url?eid=2-s2.0-79961030711&partnerID=MN8TOARS
http://scholars.lib.ntu.edu.tw/handle/123456789/367745
DOI: 10.1016/j.jdermsci.2011.05.005
metadata.dc.subject.other: placebo; ustekinumab; adult; anemia; article; controlled study; coughing; disease severity; double blind procedure; drug efficacy; drug response; drug safety; drug tolerability; drug withdrawal; eczema; eosinophilia; female; human; hyperglycemia; injection site reaction; Korea; liver function; major clinical study; male; multicenter study; opportunistic infection; perianal abscess; phase 3 clinical trial; priority journal; pruritus; psoriasis; psoriatic arthritis; randomized controlled trial; rhinopharyngitis; side effect; Taiwan; treatment outcome; upper respiratory tract infection; Adult; Antibodies, Monoclonal; Asian Continental Ancestry Group; Double-Blind Method; Female; Humans; Injections, Subcutaneous; Male; Middle Aged; Psoriasis; Republic of Korea; Severity of Illness Index; Taiwan; Treatment Outcome
[SDGs]SDG3
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臺大位居世界頂尖大學之列,為永久珍藏及向國際展現本校豐碩的研究成果及學術能量,圖書館整合機構典藏(NTUR)與學術庫(AH)不同功能平台,成為臺大學術典藏NTU scholars。期能整合研究能量、促進交流合作、保存學術產出、推廣研究成果。

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