Survival and effectiveness of leflunomide compared with methotrexate and sulfasalazine in RA

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Ann Rheum Dis. 2003 Oct;62(10):944-51.

Survival and effectiveness of leflunomide compared with methotrexate and

sulfasalazine in rheumatoid arthritis: a matched observational study.

Aletaha D, Stamm T, Kapral T, Eberl G, Grisar J, Machold KP, Smolen JS.

Division of Rheumatology, Department of Internal Medicine III,

University of Vienna, Austria. daniel.aletaha@...

OBJECTIVE: To determine the survival and clinical effectiveness of

leflunomide (LEF) compared with methotrexate (MTX) and sulfasalazine

(SSZ) for RA in an observational study. METHODS: An observational

database of 1088 patients and 5141 patient years of DMARD treatment

(2680 courses) from two academic hospitals was filtered for treatment

with LEF, MTX, and SSZ. LEF treatment groups were matched for patients'

age, baseline ESR, number of previous DMARDs, and hospital cohort with

MTX and SSZ treatment groups. For these treatments, Kaplan-Meier

analyses of time until the drug was discontinued (drug " survival " ), and

the effectiveness and safety of continuation of treatment, were

performed. The change in disease activity markers (CRP, ESR) was

compared between the groups. RESULTS: The median dose during the study

increased from 10 to 15 mg MTX/week and from 1.5 to 2.0 g SSZ/day.

Matched survival analysis showed better retention rates for MTX (mean

(SEM) survival 28 (1) months) than for LEF (20 (1) months; p=0.001),

whereas retention rates of SSZ (23 (1) months) were similar to those of

LEF (p=NS). Treatments were stopped earlier because of adverse events

(AEs, 3 months) than because of ineffectiveness (IE, 10 months;

p<0.001). LEF and MTX were less likely to be stopped because of AEs than

SSZ. LEF courses were stopped earlier for AEs (p<0.001) than MTX.

CONCLUSIONS: Current dosing strategies should be re-evaluated, and

coping strategies for common AEs should be investigated. This will be

necessary to achieve better drug retention of LEF. At present, MTX

continues to be the most effective drug in clinical practice.

PMID: 12972472

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