PMID- 36757373
OWN - NLM
STAT- MEDLINE
DCOM- 20231102
LR  - 20231102
IS  - 1744-7682 (Electronic)
IS  - 1471-2598 (Linking)
VI  - 23
IP  - 8
DP  - 2023 Jul-Dec
TI  - A non-interventional, post-marketing surveillance study evaluating the safety and 
      effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice 
      in the Republic of Korea.
PG  - 737-747
LID - 10.1080/14712598.2023.2177101 [doi]
AB  - BACKGROUND: CT-P10 was the first licensed rituximab biosimilar. This Korean 
      post-marketing surveillance study evaluated CT-P10 safety and effectiveness in 
      approved indications. RESEARCH DESIGN AND METHODS: This prospective, open-label, 
      observational, phase 4 study collected routine clinical practice data across 27 
      centers in the Republic of Korea. Patients received their first CT-P10 treatment, 
      per prescribing information, for non-Hodgkin's lymphoma (NHL), chronic 
      lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with 
      polyangiitis (GPA), or microscopic polyangiitis (MPA) during the surveillance 
      period (16 November 2016-15 November 2020). Safety (including adverse events 
      [AEs] and adverse drug reactions [ADRs]) and disease-specific clinical response 
      (by best overall response [NHL/CLL], Disease Activity Score in 28-joints [RA], or 
      Birmingham Vasculitis Activity Score for Wegener's Granulomatosis [GPA/MPA]) were 
      assessed for </=1 year (NHL/CLL) or </=24 weeks (RA/GPA/MPA). RESULTS: The safety 
      population comprised 677 patients (604 NHL, 16 CLL, 42 RA, 7 GPA, 8 MPA). 
      AEs/ADRs were reported for 68.4%/27.7% (NHL/CLL), 31.0%/14.3% (RA), and 
      86.7%/13.3% (GPA/MPA) of patients. Serious AEs and unexpected ADRs did not raise 
      new safety signals. Pneumonia was the most frequent serious ADR overall. Positive 
      effectiveness outcomes were observed. CONCLUSIONS: Findings were consistent with 
      the known CT-P10/reference rituximab safety profile, with high effectiveness 
      observed in NHL/CLL and RA.
FAU - Jo, Jae-Cheol
AU  - Jo JC
AD  - Department of Hematology and Oncology, Ulsan University Hospital, University of 
      Ulsan College of Medicine, Ulsan, Republic of Korea.
FAU - Jeon, Youngwoo
AU  - Jeon Y
AUID- ORCID: 0000-0003-3362-8200
AD  - Department of Hematology, Lymphoma and Cell Therapy-Research Center, Yeouido St. 
      Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
FAU - Kim, DaJung
AU  - Kim D
AUID- ORCID: 0000-0003-2375-8140
AD  - Department of Internal Medicine, Kosin University College of Medicine, Kosin 
      University, Seo-gu, Busan, Republic of Korea.
FAU - Yang, Deok-Hwan
AU  - Yang DH
AD  - Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 
      Chonnam National University Medical School, Hwasun-gun, Jeollanam-do, Republic of 
      Korea.
FAU - Lee, Won Sik
AU  - Lee WS
AUID- ORCID: 0000-0002-7956-468X
AD  - Department of Internal Medicine, Hemato-oncology, Inje University Busan Paik 
      Hospital, Busangjin-gu, Busan, Republic of Korea.
FAU - Choi, Yoon Seok
AU  - Choi YS
AD  - Department of Hematology-Oncology, Ajou University Hospital, Suwon, Gyeonggi-do, 
      Republic of Korea.
FAU - Yi, Jun Ho
AU  - Yi JH
AUID- ORCID: 0000-0003-1499-7131
AD  - Department of Internal Medicine, Division of Hematology and Oncology, Chung-ang 
      University Hospital, Dongjak-gu, Seoul, Republic of Korea.
FAU - Yoon, Dok Hyun
AU  - Yoon DH
AD  - Department of Oncology, Asan Medical Center, Songpa-gu, Seoul, Republic of Korea.
FAU - Kong, Jee Hyun
AU  - Kong JH
AD  - Department of Hematology-Oncology, Division of Internal Medicine, Wonju Severance 
      Christian Hospital, Wonju, Gangwon-do, Republic of Korea.
FAU - Choe, Jung-Yoon
AU  - Choe JY
AD  - Department of Internal Medicine, Daegu Catholic University School of Medicine, 
      Nam-gu, Daegu, Republic of Korea.
FAU - Kim, SungHyun
AU  - Kim S
AD  - Celltrion, Inc., Yeonsu-gu, Incheon, Republic of Korea.
FAU - Ahn, KeumYoung
AU  - Ahn K
AUID- ORCID: 0000-0002-9370-5338
AD  - Celltrion, Inc., Yeonsu-gu, Incheon, Republic of Korea.
FAU - Park, TaeHong
AU  - Park T
AUID- ORCID: 0000-0003-1922-2810
AD  - Celltrion, Inc., Yeonsu-gu, Incheon, Republic of Korea.
FAU - Ju, Hana
AU  - Ju H
AUID- ORCID: 0000-0002-9504-9995
AD  - Celltrion, Inc., Yeonsu-gu, Incheon, Republic of Korea.
FAU - Kwon, Soonbum
AU  - Kwon S
AUID- ORCID: 0000-0002-0517-8647
AD  - Celltrion, Inc., Yeonsu-gu, Incheon, Republic of Korea.
FAU - Cho, Seok-Goo
AU  - Cho SG
AUID- ORCID: 0000-0002-5429-4839
AD  - Department of Hematology, Seoul St. Mary's Hospital, The Catholic University of 
      Korea, Seocho-gu, Seoul, Republic of Korea.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230308
PL  - England
TA  - Expert Opin Biol Ther
JT  - Expert opinion on biological therapy
JID - 101125414
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 0 (CT-P10)
RN  - 0 (Biosimilar Pharmaceuticals)
SB  - IM
MH  - Humans
MH  - Rituximab/adverse effects
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy
MH  - Prospective Studies
MH  - *Arthritis, Rheumatoid/diagnosis/drug therapy
MH  - *Lymphoma, Non-Hodgkin/drug therapy
MH  - *Granulomatosis with Polyangiitis/drug therapy
MH  - Republic of Korea
MH  - Product Surveillance, Postmarketing
MH  - Treatment Outcome
OTO - NOTNLM
OT  - CT-P10
OT  - Chronic lymphocytic leukemia
OT  - granulomatosis with polyangiitis
OT  - microscopic polyangiitis
OT  - non-Hodgkin's lymphoma
OT  - rheumatoid arthritis
OT  - rituximab
EDAT- 2023/02/10 06:00
MHDA- 2023/02/10 06:01
CRDT- 2023/02/09 11:02
PHST- 2023/02/10 06:01 [medline]
PHST- 2023/02/10 06:00 [pubmed]
PHST- 2023/02/09 11:02 [entrez]
AID - 10.1080/14712598.2023.2177101 [doi]
PST - ppublish
SO  - Expert Opin Biol Ther. 2023 Jul-Dec;23(8):737-747. doi: 
      10.1080/14712598.2023.2177101. Epub 2023 Mar 8.