The efficacy and safety of leflunomide in patients with active RA

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Arthritis Rheum. 2003 Jun;48(6):1513-20.

The efficacy and safety of leflunomide in patients with active

rheumatoid arthritis: a five-year followup study.

Kalden JR, Schattenkirchner M, Sorensen H, Emery P, Deighton C, Rozman

B, Breedveld F.

Department of Internal Medicine III, University of Erlangen-Nuremberg,

Erlangen, Germany. joachim.kalden@...

OBJECTIVE: To investigate the efficacy and safety of leflunomide beyond

2 years in a multinational, open-label extension of 2 phase III

double-blind studies. METHODS: Patients with rheumatoid arthritis (RA)

who received leflunomide (100 mg/day for 3 days, 10 mg/day or 20 mg/day

thereafter) in the 2 phase III studies and who completed 2 years of

treatment were offered inclusion in the open-label extension phase and

were maintained on the same dosage of leflunomide. The American College

of Rheumatology revised criteria for 20% improvement (ACR20), ACR50, and

ACR70 response rates, the Stanford Health Assessment Questionnaire (HAQ)

scores, and C-reactive protein (CRP) levels were assessed. Safety

measures included monitoring of adverse events and laboratory values.

RESULTS: A total of 214 patients (mean age 57 years) were treated with

leflunomide for >2 years; 74.8% of the patients were female. The mean

disease duration was 4.1 years (range 0.1-26.6 years), and in 44% of

patients, RA was first diagnosed within 2 years of entry into the phase

III studies. The mean duration of leflunomide treatment was 4.6 years

(range 2.8-5.8 years), and 32% of patients had received no previous

treatment with disease-modifying antirheumatic drugs. ACR20, ACR50, and

ACR70 response rates and HAQ scores at 1 year were maintained through

year 4 or until the end point. No new types of adverse events were

observed, and liver function was normal at baseline and at the end point

in the majority of patients.

CONCLUSION: The improvements in both

functional ability and physician-based efficacy measures seen with

leflunomide after 1 year were maintained for up to 5 years (maximum

treatment duration 5.8 years), demonstrating that the early efficacy of

leflunomide in patients with RA is sustained long-term, and that the

long-term safety profile of leflunomide is no different from that

observed in phase III trials.

PMID: 12794818

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