Comparison of Effectiveness of Leflunomide against High Dose Methyl-Prednisolone in Multiple Sclerosis

Abstract

Background: Leflunomide is a disease-modifying, anti-rheumatic drug, whose active metabolite Teriflu-nomide is licensed drug therapy for reducing progression in Multiple sclerosis. Intravenous high dose Methyl-Prednisolone is an established treatment for acute relapses of multiple sclerosis that escalates reco-very. Intravenous methyl-prednisone also being used anecdotally for the prevention of relapses. Methods: Each patient after enrollment in the study received treatment for 1 year. A total of 30 patients, 15 patients in each group were taken. Patients fulfilling inclusion criteria and giving written informed con-sent were randomly divided into 2 groups (Group A and Group B) using a computer-generated random numbers table. Group A patients received Leflunomide 20mg with a loading dose of 3 tablets for 3 days and then once daily for one year. And group B patients received high-dose intravenous Methyl Prednisolone 1g monthly for a period of one year. Results: Methyl Prednisolone group, 5 (33.3%) had only 1(%) relapse and 10 (66.7%) cases had no relapse. In contrast, Leflunomide group, no relapse was recorded. The frequency of relapse was consequently statistically higher in Methyl Prednisolone group, p-value < 0.05. In respect of, a number of lesions on MRI; Methyl Prednisolone group demonstrated no change in 4 (26.67%) cases and 11 (73.33%) cases had lesions increased from baseline. Whereas, in the Leflunomide group the number of lesions significantly decreased (p-value < 0.05). Significant improvement in Expanded disability status was observed leflunomide group (p-value < 0.05). Conclusion: Leflunomide was more effective in preventing relapses and in decreasing disease activity on MRI, as compared with high dose monthly Methyl-prednisone in patients with Multiple Sclerosis.