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Abstract
Objective
To compare the safety and efficacy associated with the addition of etanercept (ETN) with that of leflunomide (LEF) in Korean rheumatoid arthritis (RA) patients, who inadequately respond to methotrexate (MTX) in a randomized, open-label study.
Methods
Twenty-nine subjects suffering moderate to severe RA, despite MTX treatment were randomly assigned to a combination therapy with either ETN or LEF. The primary end-point was the proportion of subjects achieving American College of Rheumatology (ACR20) criteria at week 16.
Results
Ninety percent (n=18) of the ETN+MTX group (n=20) and 22.2% (n=2) of the LEF+MTX group (n=9) ach-ieved an ACR20 response (p=0.001). All patients (n=20) in the ETN+MTX group showed moderate or good EULAR response as compared with 55.6% (n=5) in the LEF+MTX group (p=0.012). All of the ETN+MTX subjects completed the study without adverse events. Adverse events occurred in 77.8% (n=7) of cases in the LEF+MTX group; sig-nificantly elevated serum AST/ALT levels in 6 subjects and mild neutropenia (ANC < 1,500/μ L) in 1 subject.
Conclusion
The ETN+MTX combination therapy was effective and safe, whereas the LEF+MTX combination therapy resulted in moderate efficacy in only half of the cases, and was accompanied by a high rate of adverse events. Elevated AST/ALT was the most common adverse event causing dose adjustment or discontinuation of therapeutic agent in the LEF+MTX group.
References
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Figure 1.
Patient disposition. LEF: lefunomide, MTX: methotrexate, ETN: etanercept, LFT: liver function test, ACR: American College of Rheumatology, EULAR: European League Against Rheumatism. ∗p=0.001, † p=0.012, ‡ p<0.001. Fisher's exact test.
Table 1.
Baseline demographics and characteristics of both patient groups.
All values are mean± SD unless otherwise specified. LEF: lefunomide, MTX: methotrexate, ETN: etanercept, BMI: body mass index, DM: diabetes mellitus, NSAIDS: nonsteroidal antiinflammatory drugs, INH: isoniazid, DAS28: disease activity score based on a 28-joint count, ESR: erythrocyte sedimentation rate. The Mann-Whitney U test was used to compare the variables
Table 2.
Characteristics of patients in the LEF+MTX treatment group
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