ObjectivesThere are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).MethodsHistorical 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).ResultsThe 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.ConclusionCT-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.

Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis / R. Caporali, Y. Allanore, R. Alten, B. Combe, P. Durez, F. Iannone, M.T. Nurmohamed, S.J. Lee, T.S. Kwon, J.S. Choi, G. Park, D.H. Yoo. - In: EXPERT REVIEW OF CLINICAL IMMUNOLOGY. - ISSN 1744-666X. - 17:1(2021 Jan), pp. 85-99. [10.1080/1744666X.2020.1858803]

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

R. Caporali
Primo
;
2021

Abstract

ObjectivesThere are few comparative data for tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).MethodsHistorical 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).ResultsThe 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.ConclusionCT-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.
Adalimumab; CT-P13; biosimilar; etanercept; infliximab; rheumatoid arthritis; Administration, Cutaneous; Administration, Intravenous; Arthritis, Rheumatoid; Humans; Infliximab; Treatment Outcome; Adalimumab; Antirheumatic Agents; Biosimilar Pharmaceuticals; Etanercept
Settore MED/16 - Reumatologia
gen-2021
28-ott-2020
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/943201
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