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.

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.