Biologic drug risk

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Cancer Risks Detailed for Arthritis Drugs

Study: Arthritis patients taking Humira or Remicade face triple the

risk of developing cancer

CHICAGO, May. 17, 2006

By LINDSEY TANNER AP Medical Writer

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(AP) Rheumatoid arthritis patients taking Humira or Remicade face

triple the risk of developing several kinds of cancer and double the

risk of getting serious infections, a study led by the Mayo Clinic

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.

While the drugs' packaging information mentions some of the risks,

the manufacturers said the new study does not prove that the

medication is at fault, and they said the research was flawed.

Study co-author Dr. Matteson, a Mayo Clinic rheumatologist,

stressed the overall chances of developing cancer while using these

drugs is still small. The researchers also noted that the

medications' benefits include improving flexibility and range of

movement, easing pain and increasing life expectancy, which arthritis

can shorten.

In addition, the researchers noted that the risks for individual

patients 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 Wednesday's Journal of the American Medical

Association.

Matteson is working with Centocor in developing a new drug that works

similarly, and he and co-author Dr. Tim Bongartz have been paid

consultants to Abbott for unrelated work, but neither company funded

the study. The Mayo Foundation sponsored the research.

Rheumatoid arthritis affects more than 2 million Americans, and

involves a malfunctioning immune system that attacks joints

throughout the body, causing pain, deformities and disability.

Dr. Klippel, president of the Arthritis Foundation, said the

study will probably not change doctors' minds, because scores of

patients have benefited from the drugs. Remicade was approved in

1998, Humira in 2002.

More than a half-million patients have been treated with the two

injectable drugs and a third similar medication, Enbrel, all of which

block 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 a similar analysis on Enbrel alone.

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 JAMA.

He said the omissions were " errors of oversight on my part " and that

he was not attempting to conceal anything. Matteson said he brought

the issues to JAMA's attention on Friday.

But in an unusual move, journal editors posted a correction Tuesday

on JAMA's Web site revealing that they have asked the Mayo Clinic

College of Medicine to investigate.

The editors cited " the nature and extensiveness of this incorrect and

incomplete reporting. "

In a telphone interview Tuesday, Dr. Phil Fontanarosa, JAMA's

executive deputy editor, said that " journals are not in a position to

conduct full-scale, intense investigations when there are

concerns. ... We ask the institutions to help us in getting to the

bottom of these sorts of issues. "

The researchers analyzed data from nine studies comparing Humira or

Remicade with placebos and pooled the results. 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. They included pneumonia and cellulitis.

An Abbott spokesperson said the analysis " doesn't reflect all the

data " on Humira and said the studies were too short to sufficiently

monitor cancer incidence.

Tom Schaible, Centocor vice president of medical affairs, said most

of the analyzed studies used higher-than-recommended Remicade

doses. " There's clearly a favorable benefits-risks ratio " with

recommended doses, Schaible said.

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On the Net:

JAMA: http://jama.ama-assn.org

Arthritis Foundation: http://www.arthritis.org

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