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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
Author(s) -
Youn Sang Woong,
Yu Dae Young,
Kim Byung Soo,
Kim Youngdoe,
Kim Kwang Joong,
Choi JeeHo,
Son Sang Wook,
Lee EunSo,
Ro Young Suck,
Park Young Lip,
Lee YoungJa,
Lee Jeung Hoon,
Park Hyun Jeong,
Kim Tae Yoon,
Lee MinGeol,
Shin Min Kyung,
Choi Gwang Seong,
Kim Dong Hyun,
Jo Seong Jin,
Lee Seung Chul
Publication year - 2021
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.15670
Subject(s) - medicine , ustekinumab , observational study , postmarketing surveillance , psoriasis , psoriasis area and severity index , incidence (geometry) , adverse effect , plaque psoriasis , dermatology , disease , adalimumab , physics , optics
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.