PMID- 38415046 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240229 IS - 2040-6223 (Print) IS - 2040-6231 (Electronic) IS - 2040-6223 (Linking) VI - 15 DP - 2024 TI - Real-world safety and effectiveness of secukinumab in adult patients with moderate to severe plaque psoriasis: results from postmarketing surveillance in Korea. PG - 20406223241230180 LID - 10.1177/20406223241230180 [doi] LID - 20406223241230180 AB - 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. CI - (c) The Author(s), 2024. FAU - Kim, Byung Soo AU - Kim BS AD - Department of Dermatology, School of Medicine, Pusan National University, Busan, Republic of Korea. FAU - Kim, Dong Hyun AU - Kim DH AD - Department of Dermatology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea. FAU - Shin, Bong Seok AU - Shin BS AD - Department of Dermatology, Chosun University Hospital, Gwangju, Republic of Korea. FAU - Lee, Eun-So AU - Lee ES AD - Department of Dermatology, Ajou University School of Medicine, Suwon, Republic of Korea. FAU - Jo, Seong Jin AU - Jo SJ AD - Department of Dermatology, Seoul National University College of Medicine, Seoul, Republic of Korea. FAU - Bang, Chul Hwan AU - Bang CH AD - Department of Dermatology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. FAU - Yun, Yeojun AU - Yun Y AUID- ORCID: 0009-0007-4319-588X AD - Novartis Korea Ltd, Seoul, Republic of Korea. FAU - Choe, Yong Beom AU - Choe YB AD - Department of Dermatology, Konkuk University School of Medicine, Seoul 05030, Republic of Korea. AD - Research Institute of Medical Science, Konkuk University School of Medicine, Seoul 05030, Republic of Korea. LA - eng PT - Journal Article DEP - 20240226 PL - United States TA - Ther Adv Chronic Dis JT - Therapeutic advances in chronic disease JID - 101532140 PMC - PMC10898308 OTO - NOTNLM OT - effectiveness OT - psoriasis OT - real-world evidence OT - safety OT - secukinumab COIS- BSK served as a scientific adviser, a clinical study investigator, and/or a speaker for Abbvie, Astellas, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli Lilly, Galderma, GlaxoSmithKline, Green Cross, Janssen, Kyowa Hakko Kirin, LEO-Pharma, Novartis, Regeneron, Samsung, Sanofi, and UCB. SJJ reported receiving grants from AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion Healthcare, Green Cross Laboratories, Pfizer, and UCB and personal fees from AbbVie, Eli Lilly and Company, Janssen Pharmaceuticals, LEO Pharma, Novartis, and Sanofi. CHB has served as an investigator in clinical trials sponsored by AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Janssen, Novartis, Pfizer, and UCB biopharma, and has received consultancy fees from AbbVie, Boehringer Ingelheim, Janssen, Kolon Pharma, Lilly, and Novartis, and fees for speaking from AbbVie, Janssen, Lilly, and Novartis. DHK served as a scientific adviser, a clinical study investigator, and/or a speaker for AbbVie, Bristol-Myers Squibb, Celltrion, Eli Lilly, Green Cross, Janssen, LEO-Pharma, Novartis, and UCB. E-SL received grants for clinical research from AbbVie, Inc., Bristol-Myers Squibb, Celgene Corporation, Cell Biotech, Lilly, Janssen Pharmaceuticals, Inc., and Servier; served as an advisor or consultant for AbbVie, Inc., Celgene Corporation, Galderma Korea, Janssen Pharmaceuticals, Inc., Lilly, and Novartis Pharmaceuticals Corporation. YY is an employee of Novartis Korea Ltd. BSS and YBC report no competing interests. EDAT- 2024/02/28 06:43 MHDA- 2024/02/28 06:44 PMCR- 2024/02/26 CRDT- 2024/02/28 03:56 PHST- 2023/07/14 00:00 [received] PHST- 2024/01/10 00:00 [accepted] PHST- 2024/02/28 06:44 [medline] PHST- 2024/02/28 06:43 [pubmed] PHST- 2024/02/28 03:56 [entrez] PHST- 2024/02/26 00:00 [pmc-release] AID - 10.1177_20406223241230180 [pii] AID - 10.1177/20406223241230180 [doi] PST - epublish SO - Ther Adv Chronic Dis. 2024 Feb 26;15:20406223241230180. doi: 10.1177/20406223241230180. eCollection 2024.