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 Koreaopen access
- Authors
- Jo, Jae-Cheol; Jeon, Youngwoo; Kim, DaJung; Yang, Deok-Hwan; Lee, Won Sik; Choi, Yoon Seok; Yi, Jun Ho; Yoon, Dok Hyun; Kong, Jee Hyun; Choe, Jung-Yoon; Kim, SungHyun; Ahn, KeumYoung; Park, TaeHong; Ju, Hana; Kwon, Soonbum; Cho, Seok-Goo
- Issue Date
- Aug-2023
- Publisher
- TAYLOR & FRANCIS LTD
- Keywords
- Chronic lymphocytic leukemia; CT-P10; granulomatosis with polyangiitis; microscopic polyangiitis; non-Hodgkin's lymphoma; rheumatoid arthritis; rituximab
- Citation
- EXPERT OPINION ON BIOLOGICAL THERAPY, v.23, no.8, pp 737 - 747
- Pages
- 11
- Journal Title
- EXPERT OPINION ON BIOLOGICAL THERAPY
- Volume
- 23
- Number
- 8
- Start Page
- 737
- End Page
- 747
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/68633
- DOI
- 10.1080/14712598.2023.2177101
- ISSN
- 1471-2598
1744-7682
- Abstract
- BackgroundCT-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 methodsThis 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).ResultsThe 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.ConclusionsFindings were consistent with the known CT-P10/reference rituximab safety profile, with high effectiveness observed in NHL/CLL and RA.
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