Pulse azathioprine (AZA) and low dose methotrexate (MTX) versus standard dose MTX in treatment of patients with moderate to severe psoriasis, a randomized controlled trial.

Abstract

Psoriasis is a common chronic, immune-mediated inflammatory skin disease. Despite the availability of several systemic therapeutic agents, treatment of psoriasis remains a challenge because of the associated adverse effects and/or the financial burden of these medications, given the chronicity of the disease. We aimed to compare the efficacy and safety of combined pulse azathioprine (AZA) and low dose methotrexate versus conventional dose of methotrexate (MTX) in patients with chronic plaque psoriasis. In this randomized controlled trial, 67 patients with moderate to severe plaque psoriasis were randomized into 2 groups, receiving either combined pulse AZA (300 mg weekly dose) and low dose MTX (10 mg weekly) or conventional dose MTX (0.3 mg/kg/week) for 16 weeks. Patients were assessed for treatment response using PASI score and for the development of any adverse effects at weeks 12 and 16 and for a further 3 months after stoppage of treatment. A statistically significant higher proportion of the patients receiving combined pulse AZA and low dose MTX achieved PASI 90 and PASI 100 at week 12 and PASI 100 at week 16, compared to those receiving conventional dose of MTX monotherapy. No serious adverse events were reported during the entire study period in the two groups. Combination therapy using pulse AZA and low dose MTX can be an efficacious treatment for moderate to severe plaque psoriasis with a relatively good safety profile.