Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea
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-w...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2024-02-01
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| Series: | Therapeutic Advances in Chronic Disease |
| Online Access: | https://doi.org/10.1177/20406223241230180 |
| _version_ | 1797293871669968896 |
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| author | Byung Soo Kim Dong Hyun Kim Bong Seok Shin Eun-So Lee Seong Jin Jo Chul Hwan Bang Yeojun Yun Yong Beom Choe |
| author_facet | Byung Soo Kim Dong Hyun Kim Bong Seok Shin Eun-So Lee Seong Jin Jo Chul Hwan Bang Yeojun Yun Yong Beom Choe |
| author_sort | Byung Soo Kim |
| collection | DOAJ |
| description | 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-naïve (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-naïve (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. |
| first_indexed | 2024-03-07T21:22:06Z |
| format | Article |
| id | doaj.art-8aa2dde967ba4373bed2e744a118ae40 |
| institution | Directory Open Access Journal |
| issn | 2040-6231 |
| language | English |
| last_indexed | 2024-03-07T21:22:06Z |
| publishDate | 2024-02-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Chronic Disease |
| spelling | doaj.art-8aa2dde967ba4373bed2e744a118ae402024-02-27T10:03:33ZengSAGE PublishingTherapeutic Advances in Chronic Disease2040-62312024-02-011510.1177/20406223241230180Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in KoreaByung Soo KimDong Hyun KimBong Seok ShinEun-So LeeSeong Jin JoChul Hwan BangYeojun YunYong Beom ChoeBackground: 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-naïve (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-naïve (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.https://doi.org/10.1177/20406223241230180 |
| spellingShingle | Byung Soo Kim Dong Hyun Kim Bong Seok Shin Eun-So Lee Seong Jin Jo Chul Hwan Bang Yeojun Yun Yong Beom Choe Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea Therapeutic Advances in Chronic Disease |
| title | Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea |
| title_full | Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea |
| title_fullStr | Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea |
| title_full_unstemmed | Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea |
| title_short | Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea |
| title_sort | real world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis results from postmarketing surveillance in korea |
| url | https://doi.org/10.1177/20406223241230180 |
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