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Taking Humira or Remicade triples risk of getting cancer, study says

Rheumatoid arthritis report called flawed

CHICAGO -- The risk of developing several kinds of cancer triples for rheumatoid arthritis patients taking Humira or Remicade, and the danger of them getting a serious infection doubles with the use of the drugs, a study found.

The analysis builds on previous reports about the risks associated with Abbott Laboratories' Humira and Centocor's Remicade. But the earlier research focused mostly on one kind of cancer, lymphoma, and infections such as tuberculosis and pneumonia.

The new study found an apparent link to other cancers, too, including skin, gastrointestinal, breast, and lung tumors. It also quantifies the risks and says high doses appear to be the riskiest.

The drugs' packaging information mentions some of the risks. The manufacturers said the new study does not prove the medication is at fault, and they said the research was flawed.

Dr. Eric Matteson, a Mayo Clinic rheumatologist and coauthor of the study, stressed that the overall chances of developing cancer while using these drugs are still small. The researchers also said the medications' benefits include improving flexibility and range of movement, easing pain, and increasing life expectancy, which arthritis can shorten.

The researchers also said the risks for individuals probably vary widely. Older, sicker people who have taken the drugs for several years probably face the highest risks, they said.

Still, the researchers said, patients should be made aware of the dangers and told to seek medical help if they develop fevers, coughs, or other symptoms of infection. They should also be sure to undergo the cancer screenings recommended for the general public, the researchers said.

Their study appears in today's Journal of the American Medical Association.

Matteson is working with Centocor in developing a drug that works similarly, and he and coauthor Dr. Tim Bongartz have been paid consultants to Abbott for unrelated work. Neither company funded the study, however; the Mayo Foundation sponsored the research.

Rheumatoid arthritis is caused by the immune system attacking joints throughout the body, causing pain, deformities, and disability.

Dr. John Klippel, president of the Arthritis Foundation, said the study will probably not change doctors' minds, because scores of patients have benefited from the drugs. More than a half-million patients have been treated with the two drugs and a third similar medication, Enbrel, all of which block the production of a protein linked with inflammation.

Enbrel was not included in the study because it differs at the molecular level, Matteson said.

He said he is getting paid by Enbrel marketers Wyeth and Amgen to do an analysis on Enbrel.

Matteson's ties to Centocor and his work on Enbrel were among several omissions and errors included in disclosure statements that accompanied the study in the journal.

He said the omissions were an office mistake. But in an unusual move, journal editors posted a correction yesterday on its website disclosing that they have asked the Mayo Clinic College of Medicine to investigate.

The researchers analyzed data from nine studies comparing Humira or Remicade with placebos. There were 29 cancers in 3,493 patients who received at least one dose of either drug, compared with three cancers in 1,512 patients on placebos. Serious infections occurred in 126 patients on drugs and 26 on placebos.

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