Regulatory effects of tofacitinib combined with methotrexate on gut microbiota and clinical efficacy in patients with rheumatoid arthritis
- VernacularTitle:托法替布联合甲氨蝶呤对类风湿性关节炎患者肠道菌群的调节作用及临床疗效
- Author:
Jingxu WANG
1
;
Xiangzhuo ZHAO
1
;
Jingfang SHEN
1
;
Lianju LI
1
Author Information
1. Dept. of Rheumatology and Immunology，Xingtai People’s Hospital，Hebei Xingtai 054000，China
- Publication Type:Journal Article
- Keywords:
rheumatoid arthritis;
tofacitinib;
methotrexate;
gut microbiota;
clinical efficacy
- From:
China Pharmacy
2026;37(11):1452-1456
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To investigate the regulatory effects of tofacitinib combined with methotrexate （MTX） on gut microbiota and the clinical efficacy of this regimen in patients with rheumatoid arthritis （RA）. METHODS A retrospective analysis was conducted on the clinical data of 182 patients with RA admitted to Xingtai People’s Hospital from January 2022 to June 2025. The patients were divided into a control group （ n ＝88， treated with MTX monotherapy） and an observation group （ n ＝94， treated with tofacitinib combined w ith MTX） based on their treatment regimen. Gut microbiota abundance， inflammatory and immunological indicators [C-reactive protein （CRP）， erythrocyte sedimentation rate （ESR）， rheumatoid factor （RF）， and anti-cyclic citrullinated peptide antibody （anti-CCP） ] ， clinical efficacy indicators [American College of Rheumatology 20% response rate （ACR20）， Disease Activity Score in 28 Joints （DAS28）， and Health Assessment Questionnaire （HAQ） score ] ， and adverse reactions during treatment were compared between the two groups before and after 12 weeks of treatment. RESULTS After treatment， the abundance of Lactobacillus and Bifidobacterium were significantly increased in both groups compared with before treatment， whereas the abundances of Enterococcus and Enterobacter ， as well as the levels of CRP， ESR， RF， anti-CCP， DAS28 score， and HAQ score， were significantly decreased （ P ＜0.05）. The degree of improvement in the observation group was significantly greater than that in the control group （ P ＜0.05）. The ACR20 response rate in the observation group was significantly higher than that in the control group （81.91% vs. 56.82%， P ＜0.05）. There was no statistically significant difference in the incidence of adverse reactions between the two groups （ P ＞0.05）， and the main adverse reactions were gastrointestinal reactions and abnormal liver function. CONCLUSIONS Tofacitinib combined with MTX can effectively improve gut microbiota balance in patients with RA by increasing the abundance of probiotics and reducing the abundance of opportunistic pathogenic bacteria， thereby improving immune and inflammatory status. In addition， this combination regimen can enhance clinical efficacy， reduce disease activity， and improve functional status， with a favorable safety profile.
