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.
Bibliographical noteFunding Information:
Dr. Byung Soo Kim reports grants from Abbvie, Boehringer Ingelheim, Eli‐ Lilly, Janssen, LEO, Novartis, Regeneron, Sanofi, and UCB. Dr. Eun‐So Lee reports grants and other from AbbVie Inc., Celgene Corporation, Janssen Pharmaceuticals, Inc., and Novartis Pharmaceutical Corporation, and grants from Cell Biotech, Lilly, Servier, and Bristol‐Myers Squibb. Dr. Min‐Geol Lee reports grants and personal fees from Janssen, Norvatis, Leo‐Pharma, and Eli Lilly, and grants from Pfizer, Kyowa Kirin, Bristol‐Myers Squibb, and Boehringer Ingelheim. Dr. Seong‐Jin Jo reports grants and personal fees from Norvatis; grants from BMS, Boehringer Ingelheim, and Abbvie; and personal fees from Lily. Dae Young Yu, Youngdoe Kim, and Dr. YoungJa Lee are employees of Janssen Korea Ltd. Dr. Dong Hyun Kim, Dr. Gwang Seong Choi, Hyun Jeong Park, Jee‐Ho Choi, Jeung Hoon Lee, Kwang Joong Kim, Dr. Min Kyung Shin, Seung Chul Lee, Dr. Sang Wook Son, Sang Woong Youn, Tae Yoon Kim, Young Lip Park, and Young Suck Ro have nothing to disclose.
This study was sponsored by Janssen Korea Ltd.
© 2021 Japanese Dermatological Association
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