This group of 38 TAK cases are prescribed with methotrexate tablets (Dose: 15.0 mg. qw. p.o.) for 24 weeks.

This group of 38 TAK cases are prescribed with tofacitinib tablets (Dose: 5.0 mg. bid. p.o.) for 24 weeks.

Takayasu Arteritis

Methotrexate

Inhibition

Treatment

The methotrexate group is prescribed with methotrexate Tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
After 24 weeks of treatment, if the disease is alleviated, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead.

Methotrexate Tablets

The tofacitinib group is prescribed with tofacitinib tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
After 24 weeks of treatment, if the disease is alleviated, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead.

Tofacitinib tablet

Lindi Jiang

Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

Randomized Open-label Study in Mild and Moderate Patients With Takayasu Arteritis Between Methotrexate and Tofacitinib Based on the ECTA Cohort.

comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 24th week follow-up;

comparison of clinical remission rate between tofacitinib and methotrexate groups at the end of 48th week follow-up;

comparison of targeted prednisone usage between tofacitinib and methotrexate groups at the end of 24th and 48th week follow-up;

comparison of relapse between tofacitinib and methotrexate groups; (Relapse is defined as: (1) Major relapse: Major relapse Recurrence of active disease with either of the following: a. Clinical features of ischaemia* (including jaw claudication,visual symptoms, visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. (2) Minor relapse: Recurrence of active disease, not fulfilling the criteria for a major relapse. )

comparison of vascular change with MRA, CTA, or doppler ultrasound angiographic examinations between tofacitinib and methotrexate groups;

comparison of quality of life between tofacitinib and methotrexate groups with the 36-Item Short Form Health Survey questionnaire (SF-36) (Scores:0~100, lower score means more disability)

comparison of quality of life between tofacitinib and methotrexate groups with the questionnaire of sleep scale from medical outcomes study (MOS-sleep scale) (Scores: 11-65, lower scores indicates more difficulty in sleep)

comparison of quality of life between tofacitinib and methotrexate groups with the Fatigue severity scale (Scores: 9-63, higher score means severe fatigue)

Shanghai Zhongshan Hospital

Mild and moderate TAK patients were divided into two groups, with 38 cases for each group at the randomized ratio 1:1, prescribed with methotrexate (15mg.qw.po) and tofacitinib (5mg.bid.po) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated, the strategy would be maintained for another 24weeks, otherwise, the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint)

This group of 20 TAK cases are prescribed with tocilizumab (Dose: 8mg/kg. qm. ivgtt.) for 24 weeks.

This group of 20 TAK cases are prescribed with adalimumab (Dose: 40mg.bim.IH.) for 24 weeks.

Tocilizumab

Adalimumab

The tocilizumab group is prescribed with tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead.

The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks instead.

Department of Rheumatology in Zhongshan hospital, Fudan University

A Pilot Study in Severe Patients With Takayasu Arteritis.

A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort

comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 24th week follow-up;

comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 48th week follow-up;

comparison of targeted prednisone usage between adalimumab and tocilizumab groups at the end of 24th and 48th week follow-up;

comparison of disease relapse between adalimumab and tocilizumab groups; (Relapse is defined as: (1) Major relapse: Major relapse Recurrence of active disease with either of the following: a. Clinical features of ischaemia* (including jaw claudication,visual symptoms, visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. (2) Minor relapse: Recurrence of active disease, not fulfilling the criteria for a major relapse.)

comparison of vascular change with MRA, CTA, or doppler ultrasound angiographic examinations between adalimumab and tocilizumab groups;

comparison of quality of life between adalimumab and tocilizumab groups with the 36-Item Short Form Health Survey questionnaire (SF-36) (Scores:0~100, lower score means more disability)

comparison of quality of life between adalimumab and tocilizumab groups with the questionnaire of sleep scale from medical outcomes study (MOS-sleep scale) (Scores: 11-65, lower scores indicates more difficulty in sleep)

comparison of quality of life between adalimumab and tocilizumab groups with the Fatigue severity scale (Scores: 9-63, higher score means severe fatigue)

Severe TAK patients were divided into two groups, with 20 cases for each group at the randomized ratio 1:1, prescribed with adalimumab (40mg.bim.IH) and tocilizumab (8mg/kg.qm.ivgtt) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated (remission), the strategy would be maintained for another 24weeks, otherwise (resistant), the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint).

hemoptysis/احتشاء

Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

A Pilot Study in Severe Patients With Takayasu Arteritis.

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