Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches. For TKA refractory to TNF-α, Baricitinib, a reversible inhibitor of Janus kinases (JAK) family members JKA1 and JAK2, represents a potential treatment option. This study aims to assess the efficacy and safety of Baricitinib in TKA refractory to TNF-α inhibitors.
This is a multi-center, single-arm trial conducted to evaluate the safety and efficacy of baricitinib in Takayasu arteritis (TKA) refractory to TNF-α inhibitors. Patients in active TKA and unresponsive to at least 6 months of TNF-α inhibitors therapy were enrolled. Patients discontinued TNF-α inhibitors and received baricitinib at 4 mg/day for up to 48 weeks, which was added to the glucocorticoid and immunosuppressants. The clinical manifestations, inflammatory indicators, imaging and treatment of patients were recorded by investigators during the follow up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The patients received Baricitinib for 48 weeks. The method is to take Baricitinib 4mg every day for a period of 48 weeks. All the patients will be followed up prospectively for 48 weeks.
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Patients achieving complete remission and partial remission
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.
Time frame: Week 24
Changes of National Institutes of Health (NIH) score of patients
The manifestations, imaging findings and laboratory parametes were recorded during the follow-up. The disease activity of patients were accessed by National Institutes of Health (NIH) score. (Range: 0\~4, higher scores mean higher disease activity)
Time frame: Week 24 and week 48
Changes of Indian Takayasu Clinical Activity Score (ITAS2010) of patients
The manifestations, imaging findings and laboratory parameters were recorded during the follow-up. The disease activity of patients were accessed by Indian Takayasu Clinical Activity Score (ITAS2010). (Range: 0\~51, higher scores mean higher disease activity)
Time frame: Week 24 and week 48
Changes of C-reactive protein
Blood samples were collected from all patients and the concentration of C-reactive protein (mg/L) were recorded.
Time frame: Week 24 and week 48
Changes of erythrocyte sedimentation rate
Blood samples were collected from all patients and the erythrocyte sedimentation rates (mm/h) were recorded.
Time frame: Week 24 and week 48
Changes of dosage of glucocorticoids from baseline.
The dosage of glucocorticoids (mg/day) of all patients were recorded during the follow-up.
Time frame: Week 24 and week 48
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