Clinical and angiographic outcomes of mycophenolate versus methotrexate in South Asian patients of Takayasu arteritis: Results from an open-label, outcome-assessor blinded randomized controlled trial

Abstract

ABSTRACT Objective To compare the clinical and angiographic responses of mycophenolate mofetil (MMF) versus methotrexate (MTX) in Takayasu arteritis (TAK). Methods This was an open-label, outcome assessor–blinded trial. Adult patients with active TAK were randomized 1:1 to MMF 1 g twice daily or MTX 20 mg once weekly by a computer-generated program. All patients were started on 0.5 mg/kg of steroids with a predetermined tapering protocol. The primary outcome was the treatment response as defined by Indian Takayasu arteritis score at 9 months. The secondary end points included the time to first failure and angiographic progression. Results A total of 52 patients (26 in each arm) were recruited. The rate of responders was 71.43% (15/21) in the MMF arm and 63.64% (14/22) in the MTX arm (P = .58). The median time to the first failure was 9 months (range: 3–9) and 4.5 months (range: 3–9) in the MMF and MTX arms, respectively (P = .052). In both groups, 15% of patients (n = 3) had a progressive disease in angiography. Conclusions The results showed numerically better outcomes favouring MMF, with a longer time to the first failure than MTX (9 months versus 4.5 months, P = .052). No significant difference was seen in the angiographic outcomes.