PMID- 31734899
OWN - NLM
STAT- MEDLINE
DCOM- 20201005
LR  - 20210110
IS  - 1179-190X (Electronic)
IS  - 1173-8804 (Print)
IS  - 1173-8804 (Linking)
VI  - 34
IP  - 1
DP  - 2020 Feb
TI  - Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from 
      the Korean College of Rheumatology Biologics Registry.
PG  - 89-98
LID - 10.1007/s40259-019-00393-y [doi]
AB  - OBJECTIVE: The aim was to evaluate long-term drug retention, discontinuation, 
      efficacy and safety of CT-P13 and reference infliximab in patients with 
      rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology 
      Biologics (KOBIO) registry. METHODS: Patients included adults with RA who 
      received CT-P13 or reference infliximab between December 2012 and December 2017. 
      Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte 
      sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College 
      of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed 
      over 4-years' follow-up. RESULTS: Data from 199 RA patients (CT-P13: n = 147; 
      reference infliximab: n = 52) were analyzed. Median treatment duration was 
      1.22 years for CT-P13 and 1.40 years for reference infliximab (p = 0.67). 
      Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 
      versus reference infliximab was comparable for the overall population (p = 0.84) 
      and for first-line (p = 0.66) and subsequent treatment lines (p = 0.96). 
      Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 
      and 69.6% with reference infliximab. The most common reason for treatment changes 
      or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference 
      infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, 
      DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were 
      reported for CT-P13 and eight for reference infliximab. CONCLUSION: Long-term 
      data from patients with RA treated in routine clinical practice in Korea showed 
      that CT-P13 had a comparable drug retention rate to reference infliximab, with 
      similar efficacy and an acceptable safety profile. CLINICALTRIALS. GOV 
      IDENTIFIER: NCT01965132.
FAU - Kim, Hyoun-Ah
AU  - Kim HA
AUID- ORCID: 0000-0003-2609-3367
AD  - Department of Rheumatology, Ajou University School of Medicine, Suwon, Republic 
      of Korea.
FAU - Lee, Eunyoung
AU  - Lee E
AD  - Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, 
      Republic of Korea.
AD  - Office of Biostatistics, Ajou Research Institute for Innovative Medicine, Ajou 
      University Medical Center, Suwon, Republic of Korea.
FAU - Lee, Sun-Kyung
AU  - Lee SK
AD  - Division of Rheumatology, Seoul Metropolitan Government-Seoul National University 
      Hospital Boramae Medical Center, Seoul, Republic of Korea.
FAU - Park, Yong-Beom
AU  - Park YB
AD  - Department of Internal Medicine (Division of Rheumatology), Yonsei University 
      College of Medicine, Severance Hospital, Seoul, Republic of Korea.
FAU - Lee, Young Nam
AU  - Lee YN
AUID- ORCID: 0000-0003-2776-4708
AD  - Celltrion Healthcare Co. Ltd., Incheon, Republic of Korea.
FAU - Kang, Hee Jung
AU  - Kang HJ
AD  - Celltrion Healthcare Co. Ltd., Incheon, Republic of Korea.
FAU - Shin, Kichul
AU  - Shin K
AUID- ORCID: 0000-0002-6749-7598
AD  - Division of Rheumatology, Seoul Metropolitan Government-Seoul National University 
      Hospital Boramae Medical Center, Seoul, Republic of Korea. kideb1@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01965132
PT  - Journal Article
PL  - New Zealand
TA  - BioDrugs
JT  - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
JID - 9705305
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (CT-P13)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antirheumatic Agents
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Biosimilar Pharmaceuticals/*therapeutic use
MH  - Blood Sedimentation/drug effects
MH  - Drug Substitution/methods
MH  - Female
MH  - Humans
MH  - Infliximab/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Registries
MH  - Republic of Korea
MH  - Rheumatology/methods
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC6985057
COIS- Young Nam Lee and Hee Jung Kang are employees of Celltrion Healthcare Co., Ltd. 
      Hyoun-Ah Kim, Eunyoung Lee, Sun-Kyung Lee, Yong-Beom Park, and Kichul Shin have 
      no conflicts to declare.
EDAT- 2019/11/18 06:00
MHDA- 2020/10/06 06:00
PMCR- 2019/11/16
CRDT- 2019/11/18 06:00
PHST- 2019/11/18 06:00 [pubmed]
PHST- 2020/10/06 06:00 [medline]
PHST- 2019/11/18 06:00 [entrez]
PHST- 2019/11/16 00:00 [pmc-release]
AID - 10.1007/s40259-019-00393-y [pii]
AID - 393 [pii]
AID - 10.1007/s40259-019-00393-y [doi]
PST - ppublish
SO  - BioDrugs. 2020 Feb;34(1):89-98. doi: 10.1007/s40259-019-00393-y.