PMID- 34223982
OWN - NLM
STAT- MEDLINE
DCOM- 20230407
LR  - 20230407
IS  - 1435-1250 (Electronic)
IS  - 0340-1855 (Linking)
VI  - 82
IP  - 3
DP  - 2023 Apr
TI  - Comparative efficacy and safety of tumor necrosis factor inhibitors and their 
      biosimilars in patients with rheumatoid arthritis having an insufficient response 
      to methotrexate : A network meta-analysis.
PG  - 248-255
LID - 10.1007/s00393-021-01041-z [doi]
AB  - OBJECTIVE: This study aimed to compare the effectiveness and safety of tumor 
      necrosis factor inhibitor (TNFI) biosimilars to TNFI originators in patients with 
      active rheumatoid arthritis (RA) who responded inadequately to methotrexate 
      (MTX). METHODS: We conducted a meta-analysis of randomized controlled trials 
      (RCTs) to compare the effectiveness and safety of TNFI biosimilars to TNFIs in 
      patients with RA who had not responded adequately to MTX. RESULTS: A total of 18 
      RCTs (8 adalimumab, 7 infliximab, and 3 etanercept) comprising 4039 patients 
      randomized to TNFI biosimilars and 3905 to TNFI treatment were included. The 
      American College of Rheumatology 20% improvement (ACR20) response rate was 
      significantly higher for TNFI biosimilar-treated patients than for TNFI-treated 
      patients (odds ratio, OR 1.140, 95% confidence interval, CI 1.031-1.261, 
      P = 0.011); however, subgroup analysis by the TNFI type showed that the ACR20 
      response rates were not different among the biosimilars of adalimumab, 
      infliximab, and etanercept compared with the originators. The ACR50 response rate 
      was significantly higher for TNFI biosimilar-treated patients than for TNFI 
      treated patients (OR 1.096, 95% CI 1.001-1.200, P = 0.047). Subgroup analysis by 
      the TNFI type showed that the ACR50 response rates did not differ among the 
      biosimilars of adalimumab and infliximab compared with the originators; however, 
      the ACR50 response rate was significantly higher in etanercept biosimilar-treated 
      patients than in etanercept-treated patients (OR 1.406, 95% CI 1.111-1.780, 
      P = 0.005). No significant difference was observed between the TNFI biosimilars 
      and TNFIs as per ACR70. There was no significant difference in the number of 
      patients who experienced adverse events (AEs) between TNFI biosimilars and TNFIs 
      (OR 0.961, 95% CI 0.876-1.055, P = 0.402); however, subgroup analysis by the TNFI 
      type showed that the adalimumab biosimilar caused fewer AEs than adalimumab (OR 
      0.865, 95% CI 0.756-0.989, P = 0.034). Serious AEs and withdrawals due to AEs did 
      not differ between TNFI biosimilars and TNFIs. CONCLUSION: This meta-analysis 
      showed that TNFI biosimilars had an overall comparable efficacy and safety 
      profile compared with their originators in RA patients.
CI  - (c) 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.
FAU - Ho Lee, Young
AU  - Ho Lee Y
AUID- ORCID: 0000-0003-4213-1909
AD  - Division of Rheumatology, Department of Internal Medicine, Korea University Anam 
      Hospital, Korea University College of Medicine, 73, Goryeodae-ro, 02841, 
      Seongbuk-gu, Seoul, Korea (Republic of). lyhcgh@korea.ac.kr.
FAU - Gyu Song, Gwan
AU  - Gyu Song G
AD  - Division of Rheumatology, Department of Internal Medicine, Korea University Anam 
      Hospital, Korea University College of Medicine, 73, Goryeodae-ro, 02841, 
      Seongbuk-gu, Seoul, Korea (Republic of).
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
TT  - Vergleich der Wirksamkeit und Sicherheit von Tumornekrosefaktor-Inhibitoren und 
      ihren Biosimilars bei Patienten mit rheumatoider Arthritis mit ungenugendem 
      Ansprechen auf Methotrexat : Eine Netzwerk-Metaanalyse.
DEP - 20210705
PL  - Germany
TA  - Z Rheumatol
JT  - Zeitschrift fur Rheumatologie
JID - 0414162
RN  - YL5FZ2Y5U1 (Methotrexate)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
RN  - OP401G7OJC (Etanercept)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Humans
MH  - Methotrexate/therapeutic use
MH  - *Biosimilar Pharmaceuticals/therapeutic use
MH  - Infliximab/adverse effects
MH  - Adalimumab/adverse effects
MH  - Etanercept/therapeutic use
MH  - Tumor Necrosis Factor Inhibitors/therapeutic use
MH  - Network Meta-Analysis
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - *Antirheumatic Agents/therapeutic use
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Biosimilar
OT  - Meta-analysis
OT  - Rheumatoid arthritis
OT  - TNFI
EDAT- 2021/07/06 06:00
MHDA- 2023/04/07 10:18
CRDT- 2021/07/05 12:21
PHST- 2021/06/06 00:00 [accepted]
PHST- 2023/04/07 10:18 [medline]
PHST- 2021/07/06 06:00 [pubmed]
PHST- 2021/07/05 12:21 [entrez]
AID - 10.1007/s00393-021-01041-z [pii]
AID - 10.1007/s00393-021-01041-z [doi]
PST - ppublish
SO  - Z Rheumatol. 2023 Apr;82(3):248-255. doi: 10.1007/s00393-021-01041-z. Epub 2021 
      Jul 5.