Abstract
Leflunomide (LEF) is a conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of rheumatoid arthritis. However, there are few reports on the comparison of efficacy between LEF alone and combined with other csDMARDs. Here, the efficacy and safety of LEF monotherapy (88) and combination (361) therapy groups were evaluated. After 3 months, there were no significant differences in 28-joint disease activity score (DAS28), health assessment questionnaire (HAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) between the monotherapy and combination groups (all P > 0.05). According to the European League Against Rheumatism (EULAR) response criteria, it was found that the DAS28 response rates were similar in the two groups (P > 0.05). Besides, the two groups presented similar safety profiles. Subgroup analysis found that there was no difference in efficacy among the three combined therapies (LEF + methotrexate (MTX), LEF + hydroxychloroquine (HCQ), and LEF + MTX + HCQ) and LEF monotherapy. Furthermore, when the dose of LEF was less than 40 mg/day, no significant difference in efficacy was observed between low and high doses. Overall, these results indicated that low dose LEF monotherapy was not inferior to the combination therapy.
Highlights
Leflunomide (LEF) is a conventional synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis
In the retrospective cohort study, we mainly compared the efficacy between Rheumatoid arthritis (RA) patients with LEF monotherapy and LEF combination therapy with csDMARDs
Our study reported that there were no significant differences in the primary endpoint DAS28 and multiple secondary endpoints between the monotherapy group and the combination group after 3 months of treatment
Summary
Leflunomide (LEF) is a conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of rheumatoid arthritis. There are few reports on the comparison of efficacy between LEF alone and combined with other csDMARDs. Here, the efficacy and safety of LEF monotherapy (88) and combination (361) therapy groups were evaluated. When the dose of LEF was less than 40 mg/day, no significant difference in efficacy was observed between low and high doses Overall, these results indicated that low dose LEF monotherapy was not inferior to the combination therapy. Economical and effective csDMARDs are the first treatment strategy recommended by the European League Against Rheumatism (EULAR)[8], including leflunomide (LEF), methotrexate (MTX), hydroxychloroquine (HCQ), sulfasalazine (SSZ), cyclosporine, azathioprine and gold salts. Most studies on csDMARDs mainly focus on the efficacy and toxicity evaluation of MTX monotherapy and/or in combination with other csDMARDs, while few studies report the efficacy of LEF monotherapy or combination
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