Efficacy and safety of tofacitinib versus leflunomide with glucocorticoids treatment in Takayasu arteritis: A prospective study.

To investigate the efficacy and safety of leflunomide (LEF) versus tofacitinib (TOF) in Takayasu arteritis (TAK) patients. Sixty-seven active patients were recruited from an ongoing observational TAK cohort, including 35 patients treated with glucocorticoids (GCs) and LEF and 32 patients treated with GCs and TOF. The observation period was 12 months. The effectiveness rate (ER), remission rate, inflammatory parameters reduction, vascular imaging changes, GCs tapering, disease relapse and side-effects were evaluated between two groups. These aspects were also assessed separately among treatment-naïve or -refractory patients. The ER at 6 and 12 months was 88.57% (31/35) vs. 87.50% (28/32) (p = 1.00) and 71.43% (25/35) vs. 71.88% (23/32) (p = 1.00) in the LEF and TOF group. The percentage of patients with persistent remission from 6th to 12th months and GCs≤7.5 mg/day at 12 months was higher in TOF group (15 (46.88%) vs. 6 (17.14%) p = 0.02). The relapse prevalence was 6 (17.14%) and 7 (21.88%) (p = 0.76), respectively. Erythrocyte sedimentation rate (ESR) was decreased significantly at 6 months in both groups (p<0.05), whereas C-reactive protein (CRP) level was reduced significantly at 6 months only in the TOF group (p = 0.007). The proportion of patients with imaging improvement was higher in the TOF group (eight (25.00%) and two (5.71%), p = 0.04). Side-effect prevalence was higher in the LEF group (11 (31.43%) vs. 3 (9.38%), p = 0.04). In conclusion, LEF and TOF were comparable for TAK treatment. TOF might be a potential agent to maintain disease remission at a low dose of glucocorticoids in TAK.