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Increased Incidence of Pulmonary Disease Detected with Methotrexate But Not Rheumatoid Arthritis Drugs: Presented at ACR

By Rabiya S. Tuma

NEW ORLEANS, LA -- October 29, 2002 -- A meta-analysis of three previously published clinical trials shows that drug-induced pulmonary disease is more common among rheumatoid arthritis patients treated with methotrexate.

The same analysis showed that among those patients treated with leflunomide (Arava) or with etanercept (Enbrel) there were no cases of drug-induced pulmonary disease.

Dr. Grant Cannon, from the University of Utah in Salt Lake City, Utah, and researchers from Immunex Corporation in Seattle, Washington, as well as Aventis in Bridgewater, New Jersey and Stanford University in Stanford, California, United States, presented the findings here October 26 at the annual meeting of the American College of Rheumatology (ACR).

Methotrexate is considered the standard treatment for rheumatoid arthritis. However, Dr. Barbara Finck, with the Immunex Corporation and one of the authors of the new study, said that because of the drug's rapid approval by the Food and Drug Administration, researchers did not have until now enough patient data to determine the rate or incidence of relatively uncommon side effects.

Now that methotrexate is used as a comparator drug in efficacy studies for newer therapies, "we have larger and longer prospective studies that are large enough to allow us to calculate the rate of methotrexate-induced pulmonary disease", Dr. Finck said. Previous estimates indicated that the incidence was between 1 and 3 percent, she said.

To determine the actual rate of pulmonary complications, the researchers tallied the number of investigator-reported cases of drug-induced pulmonary disease in each of three previously published prospective, randomised, controlled trials.

They found that 9 of 987 (1 percent) patients treated with methotrexate experienced serious pulmonary complications. No such cases were reported among 683 treated with leflunomide, among 415 treated with etanercept, and 118 patients treated with placebo.

The meta-analysis indicates that the incidence of drug-related pulmonary disease was 0.92 cases per 100 patient years during the first year of treatment with methotrexate and was 0.57 cases per 100 patient years during the second year.

The only risk factor significantly associated with developing pulmonary complications according to the study's findings is increased age. The mean age of patients who developed pulmonary complications was 66 years, whereas that of patients who did not develop the complication was 55 years (p<0.001).

Researchers involved in the study had grants from Aventis, in Bridgewater, New Jersey, and Immunex, in Seattle, Washington, United States.

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