Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea

被引：1

作者：

Kim, Byung Soo ^{[1
]}

Kim, Dong Hyun ^{[2
]}

Shin, Bong Seok ^{[3
]}

Lee, Eun-So ^{[4
]}

Jo, Seong Jin ^{[5
]}

Bang, Chul Hwan ^{[6
]}

Yun, Yeojun ^{[7
]}

Choe, Yong Beom ^{[8
,9
]}

机构：

[1] Pusan Natl Univ, Sch Med, Dept Dermatol, Pusan, South Korea

[2] CHA Univ Sch Med, CHA Bundang Med Ctr, Dept Dermatol, Seongnam, South Korea

[3] Chosun Univ Hosp, Dept Dermatol, Gwangju, South Korea

[4] Ajou Univ Sch Med, Dept Dermatol, Suwon, South Korea

[5] Seoul Natl Univ Coll Med, Dept Dermatol, Seoul, South Korea

[6] Catholic Univ Korea, Seoul St Marys Hosp, Coll Med, Dept Dermatol, Seoul, South Korea

[7] Novartis Korea Ltd, Seoul, South Korea

[8] Konkuk Univ, Sch Med, Dept Dermatol, Seoul 05030, South Korea

[9] Konkuk Univ Sch Med, Res Inst Med Sci, Seoul 05030, South Korea

来源：

THERAPEUTIC ADVANCES IN CHRONIC DISEASE | 2024年 / 15卷

关键词：

effectiveness; psoriasis; real-world evidence; safety; secukinumab; INFLAMMATORY-BOWEL-DISEASE; CONTROLLED-TRIAL; EFFICACY; MULTICENTER; BIOLOGICS; USABILITY; LIFE;

D O I：

10.1177/20406223241230180

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Background: Secukinumab, a fully human monoclonal antibody, was approved in Korea for the treatment of moderate to severe psoriasis in September 2015.Objectives: To assess the safety and effectiveness of secukinumab in patients with moderate to severe psoriasis in Korea.Design: Multicenter, real-world, noninterventional study conducted over 6 years.Methods: Adults with moderate to severe psoriasis were enrolled. Safety was assessed by evaluating adverse events (AEs), treatment-related AEs, and serious AEs (SAEs). Effectiveness was assessed using the change in absolute Psoriasis Area and Severity Index (PASI) score, percentage of patients achieving PASI 75/90/100 and PASI <= 2; at weeks 12 and 24.Results: Overall, 829 and 542 patients were included in the safety and effectiveness sets, respectively. AEs, treatment-related AEs, and SAEs occurred in 29.0%, 9.5%, and 4.1% of patients, with incidence rates of 39.43, 12.98, and 5.59 per 100 patient years, respectively. The absolute PASI score decreased from 16.1 +/- 7.1 (baseline) to 1.6 +/- 2.4 (week 24), with a similar reduction in biologic-naive (16.4 +/- 7.3 to 1.5 +/- 2.2) and biologic-experienced (14.8 +/- 5.9 to 2.4 +/- 3.2) groups. At week 24, PASI 75/90/100 was achieved by 95.1%, 62.4%, and 24.9% of patients. At week 24, PASI 75/90 were higher in biologic-naive (96.6%/65.8%) than biologic-experienced patients (88.3%/48.6%), whereas PASI 100 was similar in both cohorts (24.1% and 28.6%). A similar trend in PASI <= 2 was observed in both cohorts.Conclusion: Secukinumab showed sustained effectiveness and favorable safety profile in adult patients with moderate to severe psoriasis in Korea.

引用

页数：11

共 44 条

[21] Comparison of the Efficacy and Safety of Biologics (Secukinumab, Ustekinumab, and Guselkumab) for the Treatment of Moderate-to-Severe Psoriasis: Real-World Data from a Single Korean Center [J].