Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis

Roberto Caporali, Yannick Allanore, Rieke Alten, Bernard Combe, Patrick Durez, Florenzo Iannone, Mike T. Nurmohamed, Sang Joon Lee, Taek Sang Kwon, Jean Soo Choi, Gahee Park, Dae Hyun Yoo

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Objectives: There are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA). Methods: Historical data for reference product/biosimilar intravenous infliximab, or adalimumab and etanercept, were pooled and compared with phase 3 study results for a subcutaneous (SC) formulation of the infliximab biosimilar CT-P13, in a systematic review and meta-analysis (PROSPERO: CRD42019149621). Results: The authors identified 13 eligible controlled trials that randomized over 5400 participants to prespecified treatments of interest. Comparison with pooled historical data suggested a numerical advantage for CT-P13 SC over intravenous infliximab for almost every prespecified efficacy outcome evaluated, including Disease Activity Score in 28 joints (C-reactive protein/erythrocyte sedimentation rate), Clinical/Simplified Disease Activity Index scores, American College of Rheumatology responses, and multiple measures of disease remission and low disease activity; for the majority of outcomes, there was no overlap in 95% confidence intervals between groups. A numerical advantage for CT-P13 SC was also observed for safety outcomes (adverse events, infections, and discontinuations). Similar, but less marked, trends were observed for comparison with historical efficacy and safety data for adalimumab/etanercept. Conclusion: CT-P13 SC offers an improved or similar benefit-to-harm ratio compared with infliximab (intravenous) and adalimumab/etanercept, for the treatment of moderate-to-severe RA.
Original languageEnglish
Pages (from-to)85-99
Number of pages15
JournalExpert Review of Clinical Immunology
Issue number1
Early online date2020
Publication statusPublished - Jan 2021


  • Adalimumab
  • CT-P13
  • biosimilar
  • etanercept
  • infliximab
  • rheumatoid arthritis

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