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
| Autor: | Young Suck Ro, Seung-Chul Lee, Kwang Joong Kim, YoungJa Lee, Byung Soo Kim, Youngdoe Kim, Dong-Hyun Kim, Min Geol Lee, Sang Wook Son, Young Lip Park, Sang Woong Youn, Jee Ho Choi, Gwang Seong Choi, Jeung Hoon Lee, Eun-So Lee, Dae Young Yu, Hyun Jeong Park, Tae-Yoon Kim, Min Kyung Shin, Seong Jin Jo |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Postmarketing surveillance Dermatology Severity of Illness Index 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Internal medicine Psoriasis Ustekinumab Republic of Korea medicine Humans Prospective Studies Adverse effect Survival rate Reimbursement Body surface area business.industry General Medicine medicine.disease Treatment Outcome 030220 oncology & carcinogenesis Observational study Female business medicine.drug |
| Zdroj: | The Journal of dermatologyReferences. 48(6) |
| ISSN: | 1346-8138 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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