PMID- 36447248
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221202
IS  - 2520-1026 (Electronic)
IS  - 2520-1026 (Linking)
VI  - 6
IP  - 1
DP  - 2022 Nov 30
TI  - Real world safety of CT-P10 (anti-CD 20 monoclonal antibodies biosimilar) in 
      rheumatic and autoimmune diseases.
PG  - 77
LID - 10.1186/s41927-022-00306-7 [doi]
LID - 77
AB  - BACKGROUND: Rituximab (RTX), anti-CD 20 monoclonal antibodies, has been approved 
      for many rheumatic and autoimmune diseases, the use of RTX is still limited due 
      to financial constrain. Biosimilar RTX may increase access by offering patients a 
      more affordable option, lead to improved patient outcomes. However, real-world 
      data related to its immediate and short-term safety is scarce. This study aimed 
      to evaluate the real-world immediate and short-term safety profiles of CT-P10, a 
      biosimilar of Rituximab, in patients with rheumatic and autoimmune diseases. 
      METHODS: This prospective study included patients diagnosed with rheumatic or 
      autoimmune diseases, aged >/= 18 years, who were treated with biosimilar RTX at 
      Siriraj or Ramathibodi Hospital during February 2019 to May 2019. Patients were 
      followed up through 6 months after the infusions. RESULTS: Of the 74 patients, 
      with 124 infusions, 84% were females with mean age (SD) of 49.4 (15.7) years. The 
      most common rheumatic and autoimmune disease included in this study was systemic 
      lupus erythematosus (26%). All immediate adverse events (AEs) (15 out of 124 
      infusions) were mild requiring only symptomatic and supportive treatment. 
      Short-term AEs included infection (N = 35), hematologic abnormalities (N = 33), 
      chylous ascites (N = 1), and others (N = 10). Two deaths were related to serious 
      bacterial and viral infection. Hematologic AEs comprised anemia (N = 5), 
      neutropenia (N = 10), lymphopenia (N = 15), and thrombocytopenia (N = 3). 
      CONCLUSION: In this real-world study, biosimilar RTX (CT-P10) has favorable 
      immediate and short-term safety profiles. However, further studies with large 
      sample size and long-term follow-up in real-world practice are still required to 
      confirm the result.
CI  - (c) 2022. The Author(s).
FAU - Katchamart, Wanruchada
AU  - Katchamart W
AUID- ORCID: 0000-0002-8952-5967
AD  - Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj 
      Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, 
      Thailand. wanruchada.kat@mahidol.ac.th.
FAU - Ngamjanyaporn, Pintip
AU  - Ngamjanyaporn P
AD  - Division of Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi 
      Hospital, Mahidol University, Bangkok, Thailand.
FAU - Orawongpaisarn, Annop
AU  - Orawongpaisarn A
AD  - Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj 
      Hospital, Mahidol University, 2 Wanglang Road, Bangkoknoi, Bangkok, 10700, 
      Thailand.
FAU - Phubangkertphon, Thossapoom
AU  - Phubangkertphon T
AD  - Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 
      Bangkok, Thailand.
FAU - Borrirukwisitsak, Sasimon
AU  - Borrirukwisitsak S
AD  - Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 
      Bangkok, Thailand.
FAU - Dechapaphapitak, Nichapa
AU  - Dechapaphapitak N
AD  - Division of Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi 
      Hospital, Mahidol University, Bangkok, Thailand.
LA  - eng
PT  - Journal Article
DEP - 20221130
PL  - England
TA  - BMC Rheumatol
JT  - BMC rheumatology
JID - 101738571
PMC - PMC9710159
OTO - NOTNLM
OT  - Adverse event
OT  - Biosimilar anti-CD 20 antibodies
OT  - CT-P10
OT  - Infusion reaction
OT  - Rituximab
COIS- The authors declare no conflicts of interest.
EDAT- 2022/11/30 06:00
MHDA- 2022/11/30 06:01
PMCR- 2022/11/30
CRDT- 2022/11/29 23:58
PHST- 2022/04/01 00:00 [received]
PHST- 2022/09/26 00:00 [accepted]
PHST- 2022/11/29 23:58 [entrez]
PHST- 2022/11/30 06:00 [pubmed]
PHST- 2022/11/30 06:01 [medline]
PHST- 2022/11/30 00:00 [pmc-release]
AID - 10.1186/s41927-022-00306-7 [pii]
AID - 306 [pii]
AID - 10.1186/s41927-022-00306-7 [doi]
PST - epublish
SO  - BMC Rheumatol. 2022 Nov 30;6(1):77. doi: 10.1186/s41927-022-00306-7.