Clinical Benefits


Methotrexate Has Some Clinical Benefits Over Leflunomide, But May Be More Toxic

Rheumatology Online

By James Adams

A multi-center, double-blind study has shown that both methotrexate and leflunomide are effective for prolonged treatment of rheumatoid arthritis.

Methotrexate showed some clinical advantages over leflunomide(Arava), but also appeared to be more toxic.

Investigators randomized 999 rheumatoid arthritis patients to receive either methotrexate (n=498) or leflunomide (n=501) for 52 weeks. Methotrexate was administered at a dose of 10 to 15 mg/week, and with leflunomide, patients were given a loading dose of 100 mg/day for three days followed by a maintenance dose of 20 mg/day.

Patients were given the option to continue for a second year of double-blind treatment after their first 52 weeks.

Tender and swollen joint counts as well as patient and physician assessments were the evaluated end points. Adverse effects, including elevated plasma liver enzyme levels, were also recorded. Disease progression was radiographically assessed.

Results showed that after the initial 52-week treatment, both drugs improved tender and swollen joint counts and both patient and physician assessments, with the improvements in the methotrexate group being significantly higher than those seen in the leflunomide group.

There was a small degree of disease progression seen with both drugs.

After two years of treatment, the improvement to tender joint counts and patient assessments in the two groups equalized. However, significantly less disease progression occurred in the methotrexate group.

Adverse effects seen in both groups were diarrhea, nausea, alopecia, rash, headache and elevated levels of plasma liver enzymes.

Over the two-year period, 21 patients had to be withdrawn from the methotrexate group because of elevated plasma liver enzymes. Eight were withdrawn from the leflunomide group. There were also two drug-related deaths in the methotrexate group and none in the leflunomide group.

The investigators conclude that both drugs are effective, and while methotrexate had some clinical benefit over leflunomide, its toxicity must be taken into account.

Rheumatology Online

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