The addition of leflunomide (Arava) to prednisone (Deltasone) may not improve rate of remission in Takayasu arteritis

1. Leflunomide (LEF) plus prednisone was well tolerated but did not significantly increase clinical remission of Takayasu arteritis (TAK) compared to placebo plus prednisone.

Evidence Rating Level: 1 (Excellent)

TAK is a large-vessel vasculitis that can cause severe ischemic events, potentially leading to death. While glucocorticoids are first-line therapy, disease recurrence can occur in up to 60% of patients during glucocorticoid tapering, and prolonged use has numerous side effects. Thus, there is a need for additional pharmacotherapy in TAK. While immunosuppressive therapies are used, there are few randomized clinical trials to help guide management. This multicenter, randomized, double-blind, placebo-controlled trial investigated the efficacy of LEF in active TAK. Patients with active TAK were randomized to receive LEF 10 mg twice daily (n = 54; mean [SD] age, 35.7 [11.5] years; 85.2% female) or placebo (n = 57; mean [SD] age, 33.4 [10.9] years; 92.9% female) for 24 weeks. All patients received prednisone 0.6 mg/kg/day with a taper starting at week 4. Patients in the LEF group who did not achieve clinical remission by week 24 discontinued the study; all other patients (both LEF and placebo groups) received LEF from week 25 to week 52. The primary outcome was clinical remission at week 24. At 24 weeks, 44 of 54 (81.5%) patients in the LEF arm and 45 of 57 (78.9%) patients in the placebo arm achieved remission (risk difference: 2.6, 95%CI [-12.5, 17.2]). Disease recurrence was seen in 7 and 5 patients in the LEF and placebo groups, respectively (HR: 1.36 [0.43, 4.31]). Prednisone dosage was lower in the LEF arm, although this did not reach significance (mean difference: -2.1, [-4.3, 0.1] mg/d). There were no significant differences in the incidence of adverse events.

Click here to read this study in BMC Medicine

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