Mycophenolate Mofetil Is Ineffective in the Treatment of Mucocutaneous Adamantiades-Behçet’s Disease

Abstract
Background: Cyclosporine A and azathioprine are effective on mucocutaneous lesions in Adamantiades-Behçet’s disease. Mycophenolate mofetil (MMF) is a drug resembling their activity but with comparably negligible adverse reactions. Objective: A prospective clinical proof-of-principle study was conducted to investigate the effectiveness and toxicity of MMF in mucocutaneous Adamantiades-Behçet’s disease. Methods: Thirty patients were to be treated with MMF 2 g/day p.o. for 6 months, in combination with prednisolone 30 mg/day p.o. during the first month of treatment. Inefficacy was followed by an increase in MMF dose to 3 g/day. The primary efficacy variable was the decrease in the disease activity index (DAI) according to a modified variant of the Iran Behçet’s Disease Dynamic Activity Measure system. Results: The study was interrupted due to inefficacy of the compound after the intermediate evaluation of the first 6 patients (aged 37.0 ± 7.7 years with disease duration of 10.0 ± 8.9 years) as required by the ethical committee. Although an improvement of the DAI from 5.2 ± 3.5 to 1.3 ± 0.5 was found after the first month of combination treatment, withdrawal of prednisolone led to quick relapses with a new index increase (3.0 ± 3.5). The treatment was discontinued in 3 patients after 3 months, in 2 patients after 4 months and in another one after 5 months due to deterioration of the disease. Introduction of interferon α2a (3 × 9 million IU 3×/week s.c.) in 3 patients decreased the activity index from 4.0 ± 1.0 to 0.0 ± 0.0. No adverse effects were detected under MMF treatment. Conclusion: MMF (2–3 g/day) is unable to control the signs of mucocutaneous Adamantiades-Behçet’s disease.