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No Need for Concern about Malignancies with Etanercept Treatment: Presented at IPS

By Jill Stein

NEW YORK, NY -- June 24, 2003 -- Patients with rheumatoid arthritis taking long-term etanercept therapy do not have an increased rate of malignancies, researchers reported June 19^th here at the Ninth International Psoriasis Symposium (IPS) sponsored by the Skin Disease Education Foundation.In particular, the rate of squamous-cell carcinoma is well below the expected rate, said Mark G. Lebwohl, MD, Chairman and Professor of Dermatology at Mount Sinai Hospital, in New York.

Dr. Lebwohl led a team of researchers in examining a possible link between etanercept therapy and squamous-cell carcinoma in patients with rheumatoid arthritis.

The study was prompted by a report that described seven cases of cutaneous squamous-cell carcinoma in seven patients treated with etanercept for rheumatoid arthritis (J Am Acad Dermatol 2001 Dec;45(6):953-6).

Dr. Lebwohl's group calculated the observed and anticipated incidence of squamous-cell carcinoma from pooled clinical trials and long-term extension studies of etanercept. Through April, 2002, 1,442 rheumatoid arthritis patients in these studies had received etanercept therapy, accumulating 4,044 patient-years of exposure.

The National Cancer Institute's Cancer Registry, which covers approximately 14% of the U.S. population, was used to determine the expected number of all malignancy types for the general population. The Registry provides incidence, prevalence, and mortality data for cancers but does not include information on squamous-cell or basal-cell carcinoma. The researchers therefore used two published reports from northern and southern U.S. latitudes were used to calculate the expected squamous-cell carcinoma incidence in the general U.S. population.

Results showed that in patients receiving etanercept in clinical trials the overall cancer rate was not higher than in the general population.

The incidence of lymphoma in clinical trials of etanercept for rheumatoid arthritis was consistent with the expected incidence in these patients, and was not statistically different from the expected incidence in the general population, according to the researchers.

While a population matched for age and gender would be expected to have six to 13 cases of squamous-cell carcinoma in this observation period, only four cases were observed in the studies. The median exposure duration was 3.7 years, and the maximum exposure duration was 5.7 years. The observed cases were late in onset, in contrast to anecdotal reports.

"Our results indicate that the overall incidence of cancer is not increased in patients receiving long-term etanercept therapy," Dr. Lebwohl said.

Etanercept is approved for use in psoriatic arthritis, and adult and juvenile (ages 4 to 17 years) rheumatoid arthritis; it is currently undergoing evaluation for use in psoriasis.


This study was sponsored by Amgen Inc., of Thousand Oaks, California.

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