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Clinical outcomes in adult patients with plaque psoriasis treated with ustekinumab under real-world practice in Korea: A prospective, observational, multi-center, postmarketing surveillance study

 Sang Woong Youn  ;  Dae Young Yu  ;  Byung Soo Kim  ;  Youngdoe Kim  ;  Kwang Joong Kim  ;  Jee-Ho Choi  ;  Sang Wook Son  ;  Eun-So Lee  ;  Young Suck Ro  ;  Young Lip Park  ;  YoungJa Lee  ;  Jeung Hoon Lee  ;  Hyun Jeong Park  ;  Tae Yoon Kim  ;  Min-Geol Lee  ;  Min Kyung Shin  ;  Gwang Seong Choi  ;  Dong Hyun Kim  ;  Seong Jin Jo  ;  Seung Chul Lee 
 JOURNAL OF DERMATOLOGY, Vol.48(6) : 778-785, 2021-06 
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Issue Date
Adult ; Female ; Humans ; Male ; Prospective Studies ; Psoriasis* / drug therapy ; Republic of Korea / epidemiology ; Severity of Illness Index ; Treatment Outcome ; Ustekinumab* / adverse effects
observational study ; psoriasis ; registry ; ustekinumab
Postmarketing surveillance is conducted to establish drug safety and effectiveness under real-world practice. We aimed to validate the effectiveness and safety of ustekinumab in the treatment of adult Korean patients with plaque psoriasis under real-world practice. This was a prospective, observational, and multi-center study. Subjects aged 18 years or older who were treated with ustekinumab for plaque psoriasis were enrolled. We enrolled 977 patients; 654 (66.9%) were men, with mean body surface area (BSA, ± standard deviation) of 27.0 ± 18.3% and mean psoriasis area severity index (PASI) score of 18.1 ± 9.7. The effectiveness analysis was performed in 581 patients who had at least one follow-up assessment and met treatment criteria per local label and reimbursement guidelines. Of these patients, 287 had effectiveness data for visit 6 at 53.7 ± 2.1 weeks. At visit 6, 91.6% (263/287), 51.2% (147/287), and 9.4% (27/287) patients achieved PASI 75, 90, and 100 responses, respectively. Adverse events (AEs) occurred in 112 of the 977 (11.5%) patients with an incidence rate of 21.5 per 100 patient-years (PYs). Serious AEs occurred in eight (0.8%) patients with an incidence rate of 1.2 per 100 PYs. The estimated 1-year drug survival rate was 87.7%. The multiple logistic regression analysis showed that higher baseline PASI score and no prior biologic exposure were significant predictors for PASI 90 response at visit 6. Ustekinumab was effective and safe, and displayed a high survival rate in the treatment of adult Korean patients with plaque psoriasis in real-world practice.
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1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Min Geol(이민걸) ORCID logo https://orcid.org/0000-0001-7040-5335
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