The Journal of Practical Medicine >

2026 , Vol. 42 >Issue 9: 1592 - 1599

DOI: https://doi.org/10.3969/j.issn.1006-5725.2026.09.014

Chronic Disease Control

The efficacy of high-dose tofacitinib combined with methotrexate in the treatment of refractory rheumatoid arthritis and its influence on serum anti-CCP and Th17 cytokines in patients

  • Yan LI ,
  • Tao LI ,
  • Yujing WANG ,
  • Hua ZHAO
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  • 1.Department of Rheumatology，Immunology and Hematology，Qingdao Traditional Chinese Medicine Hospital，Qingdao Hiser Hospital Affiliated of Qingdao University，Qindgao 266000，Shandong，Chin
    2Rheumatology and Immunology，Qingdao Traditional Chinese Medicine Hospital，Qingdao Hiser Hospital Affiliated of Qingdao University，Qindgao 266000，Shandong，Chin
    3Department of Orthopedics and Sports Medicine，Qingdao Traditional Chinese Medicine Hospital，Qingdao Hiser Hospital Affiliated of Qingdao University，Qindgao 266000，Shandong，China

Received date: 2026-01-07

  Online published: 2026-04-29

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Abstract

Objective To explore the clinical efficacy of high-dose tofacitinib in combination with methotrexate （MTX） for patients with refractory rheumatoid arthritis （RRA）， and its influence on serum anti-cyclic citrullinated peptide antibody （anti-CCP） and helper T cell 17 （Th17） -related cytokines. Methods The random number table method was used to divide 160 RRA patients treated in Qingdao Traditional Chinese Medicine Hospital from January 2023 to June 2025 into the high-dose group （54 cases）， the low-dose group （53 cases）， and the control group （53 cases）. These patients were respectively treated with high-dose tofacitinib （5 mg/time， twice a day） + MTX （10 mg/time， once a week）， low-dose tofacitinib （5 mg/time， once a day） + MTX （10 mg/time， once a week）， and Etanercept （25 mg/time， twice a week） + MTX （10 mg/time， once a week）， all for a 24-week treatment period. The clinical efficacy was evaluated according to the standards of the American College of Rheumatology （ACR） as the primary endpoint of the study. The secondary endpoints included changes in clinical symptoms， biochemical indicators ［erythrocyte sedimentation rate （ESR）， C-reactive protein （CRP）］， serum anti-CCP， Th17-related cytokines， Janus kinase （JAK） 3， signal transducer and activator of transcription （STAT） 3， and safety before and after treatment. Results The proportions of patients achieving ACR50 （76.92% vs. 50.00%） and ACR70 （48.08% vs. 24.00%） in the high-dose group were markedly higher than those in the control group （P < 0.05）. When compared with the pre-treatment state， the clinical symptom-related indicators， serum ESR， CRP， anti-CCP， rheumatoid factor （RF）， Th17 and its related cytokines， JAK3， and STAT3 levels in all three groups decreased significantly after treatment （P < 0.05）. Moreover， the above-mentioned indicators in the high-dose group were significantly lower than those in the other two groups after treatment （P < 0.05）. After treatment in the low-dose group， the pain visual analog score， the disease activity score based on ESR of 28 joints， serum Th17 and its related cytokines， JAK3， and STAT3 levels were significantly lower than those in the control group （P < 0.05）. There was no statistically significant difference in the incidence rates of adverse reactions among the three groups （25.00% vs. 15.38% vs. 20.00%） （P > 0.05）. Conclusions The efficacy of high-dose tofacitinib is superior to that of low-dose tofacitinib or etanercept in combination with MTX in the treatment of RRA. It can alleviate clinical symptoms， reduce the levels of serum anti-CCP， Th17-related cytokines， and JAK3/STAT3， without significantly increasing adverse reactions.

Key words： refractory rheumatoid arthritis; tofacitinib; methotrexate; anti-cyclic citrullinated peptide antibody; helper T cell 17

Cite this article

Yan LI , Tao LI , Yujing WANG , Hua ZHAO . The efficacy of high-dose tofacitinib combined with methotrexate in the treatment of refractory rheumatoid arthritis and its influence on serum anti-CCP and Th17 cytokines in patients[J]. The Journal of Practical Medicine, 2026 , 42(9) : 1592 -1599 . DOI: 10.3969/j.issn.1006-5725.2026.09.014

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