PMID- 36482248
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231123
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 10
IP  - 2
DP  - 2023 Apr
TI  - Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in 
      South Korea: Real-World Post-marketing Surveillance Data.
PG  - 329-341
LID - 10.1007/s40744-022-00515-z [doi]
AB  - INTRODUCTION: SB4 is the first approved biosimilar of etanercept, a biologic 
      tumor necrosis factor inhibitor, to treat various autoimmune diseases including 
      axial spondylarthritis (axSpA), rheumatoid arthritis (RA), psoriatic arthritis 
      (PsA), and plaque psoriasis (PsO). This post-marketing surveillance (PMS) study 
      of SB4 investigated safety and effectiveness in routine clinical practice and is 
      part of the drug approval process in Korea. METHODS: This prospective, 
      multi-center, open-label, observational, phase IV PMS study was designed to 
      enroll patients with axSpA, RA, PsA, and PsO in Korea from September 2015 to 
      September 2019. Both etanercept-naive patients or patients switched from 
      reference etanercept were included. SB4 was administered weekly via subcutaneous 
      injections using pre-filled syringes. Safety was assessed by the incidence of 
      adverse events (AEs), adverse drug reactions (ADRs) and serious adverse events 
      (SAE). Effectiveness was assessed by the change from baseline of 
      investigator-rated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in 
      patients with ankylosing spondylitis (AS) and disease activity score-28 (DAS28) 
      in patients with RA. RESULTS: Among 316 enrolled patients, 314 were included in 
      the safety analysis (176 with AS and 138 with RA). The overall incidence of AEs, 
      ADRs and serious AEs were 17.8, 9.9, and 1.3%, respectively. Most AEs were mild 
      (66.7%) or moderate (31.1%) and not related to SB4 (58.9%). Most common AEs were 
      injection site pruritus (1.9%) and injection site rash (1.3%). At week 24, mean 
      disease activity scores significantly decreased compared to baseline in naive 
      patients with AS and RA (BASDAI 2.7 vs. 6.2, p < 0.0001; DAS28 3.8 vs. 5.7, 
      p < 0.0001) and in switched patients with AS and RA (BASDAI 1.0 vs. 1.3, 
      p = 0.0018; DAS28 2.4 vs. 2.9, p = 0.0893). CONCLUSION: This first real-world 
      evidence of SB4 from a phase IV PMS study in Korea shows comparable effectiveness 
      to historical SB4 real-world evidence without any new significant safety signals.
CI  - (c) 2022. The Author(s).
FAU - Yoo, Wan-Hee
AU  - Yoo WH
AD  - Division of Rheumatology, Department of Internal Medicine, Jeonbuk National 
      University Medical School and Research Institute of Clinical Medicine of Jeonbuk 
      National University Hospital, Jeonju, Korea.
FAU - Kang, Young Mo
AU  - Kang YM
AD  - Division of Rheumatology, Department of Internal Medicine, Kyungpook National 
      University Hospital, Daegu, Korea.
FAU - Kim, Dong Wook
AU  - Kim DW
AD  - Inje University Busan Paik Hospital, Busan, Korea.
FAU - Kang, Eun Ha
AU  - Kang EH
AD  - Division of Rheumatology Department of Internal Medicine, Seoul National 
      University Bundang Hospital, Seongnam, Korea.
FAU - Lee, Yeon-Ah
AU  - Lee YA
AD  - Division of Rheumatology, Department of Internal Medicine, Kyung Hee University 
      Hospital, Seoul, Korea.
FAU - Suh, Chang-Hee
AU  - Suh CH
AD  - Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea.
FAU - Sung, Yoon-Kyoung
AU  - Sung YK
AD  - Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 
      Seoul, Korea.
FAU - Lee, Sang-Hoon
AU  - Lee SH
AD  - Department of Rheumatology, Kyung Hee University Hospital at Gangdong, Kyung Hee 
      University, Seoul, Korea.
FAU - Gu, Dong-Ha
AU  - Gu DH
AD  - Samsung Bioepis, Incheon, Korea.
FAU - Lee, Jiwon
AU  - Lee J
AD  - Samsung Bioepis, Incheon, Korea.
FAU - Choe, Jung-Yoon
AU  - Choe JY
AUID- ORCID: 0000-0003-0957-0395
AD  - Division of Rheumatology, Department of Internal Medicine, Daegu Catholic 
      University School of Medicine, 33, Duryugongwon-Ro 17-Gil, Nam-Gu, Daegu, 
      Republic of Korea. jychoe@cu.ac.kr.
LA  - eng
PT  - Journal Article
DEP - 20221208
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC10011358
OTO - NOTNLM
OT  - Ankylosing spondylitis
OT  - Biosimilar
OT  - Effectiveness
OT  - Etanercept
OT  - Post-marketing surveillance
OT  - Real-world evidence
OT  - Rheumatoid arthritis
OT  - SB4
OT  - Safety
EDAT- 2022/12/10 06:00
MHDA- 2022/12/10 06:01
PMCR- 2022/12/08
CRDT- 2022/12/09 00:54
PHST- 2022/10/11 00:00 [received]
PHST- 2022/11/22 00:00 [accepted]
PHST- 2022/12/10 06:00 [pubmed]
PHST- 2022/12/10 06:01 [medline]
PHST- 2022/12/09 00:54 [entrez]
PHST- 2022/12/08 00:00 [pmc-release]
AID - 10.1007/s40744-022-00515-z [pii]
AID - 515 [pii]
AID - 10.1007/s40744-022-00515-z [doi]
PST - ppublish
SO  - Rheumatol Ther. 2023 Apr;10(2):329-341. doi: 10.1007/s40744-022-00515-z. Epub 
      2022 Dec 8.