https://scholars.lib.ntu.edu.tw/handle/123456789/517666
標題: | 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) | 作者: | TSEN-FANG TSAI Ho J.-C. Song M. Szapary P. Guzzo C. Shen Y.-K. Li S. Kim K.-J. Kim T.-Y. Choi J.-H. Youn J.-I. |
公開日期: | 2011 | 卷: | 63 | 期: | 3 | 起(迄)頁: | 154-163 | 來源出版物: | Journal of Dermatological Science | 摘要: | 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: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-79961030711&doi=10.1016%2fj.jdermsci.2011.05.005&partnerID=40&md5=d7829d341752362b5d3c8b6cfcb7a934 https://scholars.lib.ntu.edu.tw/handle/123456789/517666 |
ISSN: | 0923-1811 | DOI: | 10.1016/j.jdermsci.2011.05.005 | SDG/關鍵字: | 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 |
顯示於: | 醫學系 |
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