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Potential application of measuring serum infliximab levels in rheumatoid arthritis management: A retrospective study based on KURAMA cohort data.

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.

SUBMITTER: Nakae K

PROVIDER: S-EPMC8513849 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundRheumatoid arthritis (RA) is a significant issue, particularly in bone health problems, because it can prolong diseases like secondary osteoporosis. Subsequently, the anchor of drug therapy for RA is methotrexate (MTX), which also has the potential to reduce the risk of secondary osteoporosis.ObjectiveThis study aims to examine the effect of MTX on calcium levels, an important parameter for monitoring bone health and the risk of secondary osteoporosis in patients with RA.MethodsA retrospective study was carried out by collecting data from the medical records of patients, which included demographic and patient characteristics, treatment data (drug and dosage), duration of treatment, and calcium levels. All patients were diagnosed with RA and fell within the age range of 18 to 59 years. Additionally, the effectiveness of MTX therapy was compared with other treatments, categorizing patient data accordingly. Statistical analyses, such as χ2 and ordinal regression, using IBM-SPSS Statistics version 25 (IBM-SPSS Inc, Armonk, New York) were used to establish associations between MTX treatment and calcium levels, reporting odds ratio and 95% CI values.ResultsThe data consisted of 123 patients with RA, comprising 99 who had a history of MTX use for more than 6 months and 24 who either did not use MTX or used it for <6 months. The majority of patients were women and their ages ranged between 40 and 59 years. MTX monotherapy was the most used with a dose range of 7.5 to 15 mg. Furthermore, this study observed that patients treated with MTX between 7.5 and 15 mg have lower serum calcium levels than those who received 17.5 to 25 mg (P = 0.022; odds ratio = 5.663; 95% CI, 0.251-3.218). Most patients with RA using MTX maintained normal calcium levels. No significant differences were observed between single MTX therapy and combination therapy.ConclusionsAlthough further investigation is needed, this study showed the potential properties of MTX in maintaining patients' serum calcium levels, which may help to reduce the risk of secondary osteoporosis in patients with RA.

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Potential application of measuring serum infliximab levels in rheumatoid arthritis management: A retrospective study based on KURAMA cohort data.

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