PMID- 32356239
OWN - NLM
STAT- MEDLINE
DCOM- 20210407
LR  - 20210407
IS  - 1179-190X (Electronic)
IS  - 1173-8804 (Print)
IS  - 1173-8804 (Linking)
VI  - 34
IP  - 4
DP  - 2020 Aug
TI  - Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with 
      Immune-Mediated Inflammatory Diseases in Observational Cohort Studies.
PG  - 513-528
LID - 10.1007/s40259-020-00421-2 [doi]
AB  - BACKGROUND: At EU marketing authorisation, safety data for CT-P13 (biosimilar 
      infliximab) were limited, particularly in some indications, and uncommon adverse 
      events (AEs) could not be evaluated among relatively small analysis populations. 
      OBJECTIVES: Our objective was to investigate the overall safety profile and 
      incidence rate of AEs of special interest (AESIs), including serious infections 
      and tuberculosis, in CT-P13-treated patients. METHODS: Data were pooled from six 
      observational studies representing authorised indications of CT-P13 (ankylosing 
      spondylitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, adult 
      and paediatric Crohn's disease and ulcerative colitis). Patients were analysed by 
      indication and treatment (patients who received CT-P13 or those who switched from 
      reference infliximab to CT-P13 </= 6 months prior to enrolment or during the 
      study). RESULTS: Overall, 4393 patients were included (n = 3677 CT-P13 group; 
      n = 716 switched group); 64.03% of patients had inflammatory bowel disease and 
      6.31% of patients were antidrug antibody positive. Overall, 32.94% and 9.58% of 
      patients experienced treatment-emergent AEs (TEAEs) and treatment-emergent 
      serious AEs, respectively. Across indications, TEAEs were more frequent with 
      CT-P13 than with the switched group. Infections including tuberculosis were the 
      most frequent serious AESI overall (2.48%) and by treatment group or indication. 
      In total, 14 patients (0.32%) reported active tuberculosis. Overall incidence 
      rates per 100 patient-years (95% confidence interval) were 3.40 (2.788-4.096) for 
      serious infections including tuberculosis and 0.44 (0.238-0.732) for active 
      tuberculosis. Infusion-related reactions were the second most frequent AESI 
      following infection including tuberculosis. CONCLUSION: The CT-P13 safety profile 
      appears consistent with previous studies for CT-P13 and reference infliximab, 
      supporting the favourable risk/benefit balance for CT-P13 treatment.
FAU - Lee, Sang Joon
AU  - Lee SJ
AUID- ORCID: 0000-0001-9897-2163
AD  - CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic 
      of Korea. sangjoon.lee@celltrion.com.
FAU - Baek, KyungMin
AU  - Baek K
AUID- ORCID: 0000-0002-7589-0656
AD  - CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic 
      of Korea.
FAU - Lee, Sujin
AU  - Lee S
AD  - CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic 
      of Korea.
FAU - Lee, Yoon Jee
AU  - Lee YJ
AUID- ORCID: 0000-0002-1727-0299
AD  - CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic 
      of Korea.
FAU - Park, Jeong Eun
AU  - Park JE
AUID- ORCID: 0000-0003-2842-2347
AD  - CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic 
      of Korea.
FAU - Lee, Seul Gi
AU  - Lee SG
AD  - CELLTRION, Inc., 19F, IBS Building, 263 Central-ro, Yeonsu-gu, Incheon, Republic 
      of Korea.
LA  - eng
PT  - Case Reports
PT  - Journal Article
PT  - Observational Study
PL  - New Zealand
TA  - BioDrugs
JT  - BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
JID - 9705305
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (CT-P13)
RN  - 0 (Pharmaceutical Preparations)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Child
MH  - Cohort Studies
MH  - Humans
MH  - *Inflammatory Bowel Diseases/drug therapy
MH  - Infliximab/adverse effects
MH  - Marketing
MH  - *Pharmaceutical Preparations
MH  - Treatment Outcome
PMC - PMC7223987
COIS- SJL, KMB, SL, YJL, JEP, and SGL are employees of CELLTRION, Inc. (Incheon, 
      Republic of Korea). SJL and KMB are shareholders in CELLTRION, Inc.
EDAT- 2020/05/02 06:00
MHDA- 2021/04/10 06:00
PMCR- 2020/05/14
CRDT- 2020/05/02 06:00
PHST- 2020/05/02 06:00 [pubmed]
PHST- 2021/04/10 06:00 [medline]
PHST- 2020/05/02 06:00 [entrez]
PHST- 2020/05/14 00:00 [pmc-release]
AID - 10.1007/s40259-020-00421-2 [pii]
AID - 421 [pii]
AID - 10.1007/s40259-020-00421-2 [doi]
PST - ppublish
SO  - BioDrugs. 2020 Aug;34(4):513-528. doi: 10.1007/s40259-020-00421-2.