RESEARCH - Cancer risk with Humira and Remicade

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Medscape

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Arthritis Drugs May Up Cancer Risk

Miranda Hitti

May 16, 2006 -- Rheumatoid arthritis patients who take the newer biologic

medications have a threefold increase in cancer risk over patients who don't

take them, a new analysis suggests.

Researchers also concluded that the patients taking the tumor necrosis

factor (TNF)-blocking drugs Remicade and Humira were twice as likely to

develop serious infections.

Rheumatoid arthritis patients are at increased risk for infections,

regardless of their treatment, and recent studies indicate that patients are

also more likely to develop malignancies.

In rheumatoid arthritis, the bodys immune system attacks the joints and

sometimes other organs. For those patients with moderate to severe disease,

drugs (such as TNF blockers and methotrexate) which help suppress the immune

system can be used for treatment.

Putting Risk in Perspective

The new analysis, published in the May 17 issue of The Journal of the

American Medical Association, offers some of the strongest evidence yet that

TNF-blocking drugs, which have been used by more than half a million

patients, further increase the risk of malignancies.

Patients should be made aware of the risks associated with treatment, but

these risks should not be overstated, says researcher Matteson, MD, of

the Mayo Clinic in Rochester, Minn.

He points out that the long-term cancer risk among patients who use the

drugs is not known because none of the studies has lasted much longer than a

year.

Rheumatoid arthritis is a bad disease, and patients have severe functional

limitations and even decreased life expectancy, he tells WebMD. There is no

question that these drugs represent a major advance in the treatment of this

disease. The drugs improve function, reduce joint destruction, and even

improve survival.

Higher Doses, More Cancers

Three TNF-inhibiting biologics have been approved for the treatment of

rheumatoid arthritis Remicade, Humira, and Enbrel.

Enbrel studies were not included in the analysis because the drug acts

somewhat differently than the other two medications. But there is no

suggestion that it is any safer or less safe than the others with regard to

cancer and infection risk, Matteson says.

The analysis included nine trials of Remicade and Humira involving 3,493

patients treated with the TNF-blocking antibodies and 1,512 patients treated

with placebo instead of the biologics. The shortest trial in the analysis

was 12 weeks long and the longest was 54 weeks.

All data on serious infections (such as pneumonia) and cancers were pooled;

the cancer risk among patients taking the biologics was found to be 3.3

times that of placebo-treated patients.

Twenty-nine malignancies were reported among the roughly 3,500 patients who

got the active biologic, compared to three malignancies among the roughly

1,500 placebo-treated patients.

The most cancers were seen among patients treated with the highest doses of

the TNF-inhibiting drugs; lymphomas and basal cell cancers were the most

commonly reported malignancies.

Few Other Options

Matteson says he continues to use the biologics in many of his patients, but

he adds that it is important to make patients aware of the potential risks

when considering treatment options.

Most of the patients appropriate for this therapy do not have other good

options, he says. TNF-blocking agents " have revolutionized the way we treat

rheumatoid arthritis, especially in patients who do not respond to

conventional therapies.

Mount Sinai School of Medicine rheumatologist Lahita, MD, PhD,

agrees. He says the newly published analysis is important because it is the

first study to quantify the cancer risk associated with the use of these

drugs.

He points out that the cancers seen most often in the study tend to be

highly treatable. And he adds that patients with few other arthritis

treatment alternatives will probably consider the risk acceptable.

The change in patients who are virtually crippled by this disease when you

give them a TNF-inhibitor can be miraculous, he says. For these patients,

the benefits of taking these drugs will continue to outweigh the risks.

Remicade is also used to treat other conditions including Crohns disease,

ankylosing spondylitis, ulcerative colitis, and psoriatic arthritis.

--------------------------------------------------------------------------------

SOURCES: Bongartz, T. The Journal of the American Medical Association, May

17, 2006; vol 295: pp 2275-2285. L. Matteson, MD, MPH, professor of

medicine, department of rheumatology, Mayo Clinic, Rochester, Minn.

Lahita, MD, professor of medicine, Mount Sinai School of Medicine, New York

City; chairman of medicine, Jersey City Medical Center.

Reviewed by Louise Chang

http://www.medscape.com/viewarticle/532410

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Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

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