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Abstract
Infliximab (IFX) therapy has considerably improved the treatment of rheumatoid arthritis (RA). However, some patients still do not respond adequately to IFX therapy, or the efficacy of the treatment diminishes over time. Although previous studies have reported a relationship between serum IFX levels and therapeutic efficacy, the potential applications of IFX therapeutic drug monitoring (TDM) in clinical practice remain unclear. The purpose of this study was to investigate the potential applications of IFX TDM by analyzing a Japanese cohort database. Data were collected retrospectively from the Kyoto University Rheumatoid Arthritis Management Alliance cohort between January 1, 2011, and December 31, 2018. Serum IFX levels were measured using a liquid chromatography-tandem mass spectrometer. Out of the 311 RA patients that used IFX, 41 were eligible for the analysis. Serum IFX levels were significantly higher in responders than in non-responders. An optimal cut-off value was determined to be 0.32 μg/mL based on a receiver operating characteristic curve. At the IFX measurement point, a better therapeutic response was observed in the high IFX group (n = 32) than in the low IFX group (n = 9). Conversely, at the maximum effect point, when DAS28-ESR was the lowest between IFX introduction and measurement points, there were no differences in responder proportions between the low and high IFX groups. IFX primary ineffectiveness could be avoided with appropriate dose escalation without blood concentration measurement in clinical practice. In conclusion, IFX TDM could facilitate the identification of secondary non-responders and in turn, proper IFX use.
Highlights
Infliximab (IFX) is a chimeric monoclonal antibody composed of human constant and murine variable regions that bind to tumor necrosis factor alpha (TNF-α)
Demographics and clinical characteristics at baseline are represented as means ± standard deviation (SD) for continuous data and numbers for categorical data
therapeutic drug monitoring (TDM) of infliximab in rheumatoid arthritis management results obtained from this study strongly suggested that physicians increased IFX doses to appropriate levels in each patient even without measuring blood levels, and that primary ineffectiveness could be avoided in clinical practice
Summary
Infliximab (IFX) is a chimeric monoclonal antibody composed of human constant and murine variable regions that bind to tumor necrosis factor alpha (TNF-α). IFX therapy has substantially improved the treatment of rheumatoid arthritis (RA). The result of Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy (ATTRACT) study has revealed that IFX therapy provided clinical benefits and halted joint damage progression [1, 2]. In some patients, the efficacy of IFX therapy is not adequate, or is gradually lost with the lapse of the treatment [3,4,5,6]. One of the current challenges in IFX therapy is to avoid secondary non-response in long-term treatment
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