Comparative evaluation of efficacy of leflunomide versus combination of methotrexate and hydroxychloroquine in patients of rheumatoid arthritis - An Indian experience

Abstract Introduction Methotrexate (MTX) is most widely used both as monotherapy and in combination therapy for the treatment of rheumatoid arthritis (RA). Combinations of different disease modifying anti-rheumatic drug/s provide additional or even have potentiating effects and therefore have become widely used. Leflunomide (LEF) alone has been seen to improve both the subjective symptoms and the objective parameters in RA. Material and methods An open label, prospective, comparative clinical study was conducted with 100 patients, divided into two groups of 50 patients in each. Subjects in group-1 were given LEF (20 mg/day) and group-2 received a combination of MTX (initial dose of 7.5 mg/week escalated to 25 mg/week) and hydroxychloroquine (HCQ) (200 mg twice a day). The various scores and parameters of disease activity were compared every 4 weeks for 12 weeks using Disease Activity Score (DAS28) and Clinical Disease Activity Index (CDAI) scores. Results At 4 weeks, in group-1, DAS28 improved by 1.28 and CDAI improved by 16.82; while in group-2, DAS28 and CDAI improved by1.02 and 14.39 respectively. At 12 weeks, DAS28 and CDAI improved by 2.22 and 25.33 in group-1 and 2.35 and 26.53 in group-2 respectively. When DAS28 was compared in between groups, it was insignificant at baseline, 4 weeks, and 12 weeks with a p -value of 0.547, 0.960 and 0.182 respectively, which suggested that both groups were comparable throughout the study. The comparison of CDAI between the groups was insignificant at baseline, 4 weeks and 12 weeks with a p -value of 0.634, 0.893 and 0.333 respectively, which also suggested that disease activity in both group were comparable from baseline to 12 weeks. Conclusions LEF was found to have equal efficacy as the combination of MTX and HCQ in reducing DAS28 and CDAI score (i.e. from severe to moderate disease activity) and so may be considered as initial therapy in RA.