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Treatment efficacy and safety of tofacitinib versus methotrexate in Takayasu arteritis: a prospective observational study
  1. Xiufang Kong1,
  2. Ying Sun1,
  3. Xiaojuan Dai1,
  4. Li Wang1,
  5. Zongfei Ji1,
  6. Huiyong Chen1,
  7. Xuejuan Jin2,
  8. Lili Ma1,
  9. Lindi Jiang1,3
  1. 1 Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China
  2. 2 Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China
  3. 3 Center of Clinical Epidemiology and Evidence-based Medicine, Fudan University, Shanghai, People's Republic of China
  1. Correspondence to Dr Lindi Jiang, Rheumatology, Zhongshan Hospital Fudan University, Shanghai, China; zsh-rheum{at}


Objective To compare the treatment efficacy and safety of tofacitinib (TOF) versus methotrexate (MTX) in Takayasu arteritis (TAK).

Methods Fifty-three patients with active disease from an ongoing prospective TAK cohort in China were included in this study. Twenty-seven patients were treated with glucocorticoids (GCs) and TOF, and 26 patients were treated with GCs with MTX. The observation period was 12 months. Complete remission (CR), inflammatory parameter changes, GCs tapering and safety were assessed at the 6th, 9th and 12th month. Vascular lesions were evaluated at the 6th and 12th month, and relapse was analysed during 12 months.

Results The CR rate was higher in the TOF group than in the MTX group (6 months: 85.19% vs 61.54%, p=0.07; 12 months: 88.46% vs 56.52%, p=0.02). During 12 months’ treatment, patients in the TOF group achieved a relatively lower relapse rate (11.54% vs 34.78%, p=0.052) and a longer median relapse-free duration (11.65±0.98 vs 10.48±2.31 months, p=0.03). Average GCs dose at the 3rd, 6th and 12th month was lower in the TOF group than that in the MTX group (p<0.05). A difference was not observed in disease improvement or disease progression on imaging between the two groups (p>0.05). Prevalence of side effects was low in both groups (3.70% vs 15.38%, p=0.19).

Conclusion TOF was superior to MTX for CR induction, a tendency to prevent relapse and tapering of the GCs dose in TAK treatment. A good safety profile for TOF was also documented in patients with TAK.

  • autoimmune diseases
  • outcome assessment
  • health care
  • therapeutics

Data availability statement

Data are available upon reasonable request. All the data can be available upon reasonable request.

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Data availability statement

Data are available upon reasonable request. All the data can be available upon reasonable request.

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  • Handling editor Josef S Smolen

  • Contributors XK was responsible for data analysis and manuscript writing. YS was responsible for data collection of patients treated with MTX. XD helped data collection of patients treated with tofacitinib. LW helped with MRI analysis in this study. ZJ, HC and LM were responsible for the follow-up of patients. LJ was responsible for the whole study design.

  • Funding This work was supported by the National Natural Science Foundation of China (grant numbers 81771730 and 81801598), the Science and Technology Commission of Shanghai Municipality (20YF1406800 and 17140902000), China Postdoctoral Science Foundation (2020M671008), Clinical Research Project of Zhongshan Hospital (No. 2020ZSLC14) and the Youth Research Fund of Zhongshan Hospital, Fudan University (2020ZYYS-001).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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