Effectiveness and safety of methotrexate versus leflunomide in 12-month treatment for Takayasu arteritis

Abstract

Aims: The study investigates the effectiveness and safety of methotrexate (MTX) versus leflunomide (LEF) in 12-month treatment of Takayasu arteritis (TAK). Methods: This was a cohort study. Patients diagnosed with TAK between 1 January 2013 and 1 January 2019 were enrolled from First Hospital of China Medical University and Zhongshan Hospital of Fudan University. Patients had active disease and were treated with glucocorticoid combined with LEF or MTX. Treatment response, imaging assessment and side-effects were evaluated during 12-month follow-up. Results: In total, 68 patients were enrolled (40 cases treated with LEF and 28 treated with MTX). At baseline, age, sex, disease duration and disease activity index showed no significant differences between groups. Prevalence of complete remission (CR) at 6 months was significantly higher in the LEF group than that in the MTX group (LEF versus MTX: 72.50% versus 53.57%, p = 0.04), though the CR prevalence at 9 months and 12 months showed no significant differences between groups. At 9 months, the prevalence of treatment resistance was much lower in the LEF group compared with MTX group (5.41% versus 11.54%, p = 0.03). Furthermore, prevalence of disease relapse in the LEF group was lower than that in MTX group at 12 months (7.24% versus 16.67%, p = 0.03). Patients with high baseline C-reactive protein levels (⩾15 mg/L) carried a higher risk of treatment resistance (OR = 1.36, 95% CI 1.07–13.41, p = 0.06) and disease relapse (HR = 2.51, 95% CI 1.36–12.98, p = 0.04). Conclusion: LEF might provide a quicker treatment response with lower prevalence of disease relapse compared with that elicited in MTX during 12 months follow-up for TAK.

Disease-modifying anti-rheumatic drugs for the management of Takayasu arteritis—a systematic review and meta-analysis

“…Five observational studies assessed methotrexate in TAK [ 33 , 60 , 64 , 67 , 93 ]. Among the two studies reporting outcomes with methotrexate alone [ 33 , 64 ], pooled proportion of patients attaining at least partial clinical response was 50% (95% CI 33–67%, 34 patients, I 2 not assessable, Fig.…”

“…4c )[ 33 ]. The three studies comparing methotrexate with other DMARDs [ 60 , 67 , 93 ] shall be discussed subsequently.…”

“…Six observational studies (and a seventh study, a longer-term follow-up of one of the previous ones) assessed leflunomide in TAK [ 42 , 57 , 82 , 83 , 93 , 94 , 99 ]. For the three uncontrolled observational studies, the pooled proportion of patients achieving at least a partial clinical response was 80% (95% CI 70–89%, 3 studies, 73 patients, I 2 not assessable, Fig.…”

“…The four studies comparing leflunomide with other DMARDs [ 57 , 83 , 93 , 94 ] shall be subsequently discussed.…”

“…95% CI 0.84–1.21, 26 methotrexate, 37 leflunomide). Frequency of relapses was similar in both groups at 12 months (risk ratio for leflunomide versus methotrexate 0.47, 95% CI 0.08–2.61, 26 methotrexate, 37 leflunomide) with no difference in proportions of patients developing adverse effects (risk ratio for leflunomide versus methotrexate 1.05, 95% CI 0.42–2.62, 26 methotrexate, 37 leflunomide) [ 93 ].…”