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Downside to Biologics Is Lower Immunity, Increased Risk of Shingles, Others Find
By Kathleen Doheny
WebMD Health News
Reviewed by Brunilda Nazario, MD
June 8, 2012 -- Rheumatoid arthritis patients who take medications known as anti-TNFs may be treating more than their disease. According to new research presented at a European meeting, these patients may be less likely to have a heart attack and are more likely to live longer than those with RA who are not taking the drugs.
In one study, the longer the patients take the anti-TNF drugs, the more protected they are from heart attacks.
"The unique feature of this study is, we have tied the time on the drugs with the reduction of heart attacks and other problems," says researcher Michael Nurmohamed, MD, PhD, of the VU University Medical Centre and Jan van Breemen Research Institute in Reade, Netherlands.
"After one year on anti-TNFs, we saw a 24% reduction, after two years, 42%, and after three years, 56%, compared to those not on the drugs," he tells WebMD.
He presented the findings this week at EULAR 2012, the Annual Congress of the European League Against Rheumatism. The study was funded by Abbott, which makes the anti-TNF drug Humira.
At the same meeting, other researchers also reported those on biologic treatments (such as anti-TNFs) have a reduced risk of death compared with those treated with traditional RA drugs.
Other researchers found earlier control and resolution of disease activity reduced the risk of death.
Not all of the research was positive, though. In a fourth study, researchers reported an increased risk of getting shingles while on the anti-TNF drugs. The often painful condition is caused by the herpes zoster virus in adults.
RA & RA Drugs
About 1.3 million Americans have RA, in which inflammation of the joints and surrounding tissue can cause pain and stiffness.
Drugs known as disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (Rheumatrex, Trexall), are typically prescribed first.
If they don't give enough relief, other drugs, including anti-TNFs, are often added. Among them: Cimzia (certolizumab), Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), and Simponi (golimumab).
Anti-TNF drugs belong to a class known as biologics, which are designed to inhibit parts of the immune system that cause inflammation.
DMARDs cost about $45 to $120 a month. Anti-TNF drugs, given intravenously or injected, cost about $1,700 a month or more, according to the American College of Rheumatology.
Anti-TNFs & Heart Attacks Study
In his study, Nurmohamed evaluated nearly 110,000 patients with RA on various types of RA drugs.
He then calculated risk reduction with the anti-TNF drugs.
The reduced risk for heart attacks, he says, is tied to suppressing inflammation.
"We know now that inflammation is important for atherosclerosis," so suppressing it is good not only for the RA but for heart attack risk reduction, he says.
"The take-home message is that disease activity should be reduced a much as possible, first by DMARDS. If that is not enough, biologics should be considered from a cardiovascular point of view."
Nurmohamed reports speaker's fees and consultant work for Abbott and other pharmaceutical companies.
RA, Biologics & Life Expectancy Study
In another study of nearly 9,000 RA patients, German researchers found those on the anti-TNF drugs had about half the risk of death as those on DMARDs during the follow-up period of about 3.5 years.
Nearly the same benefit was found for those on rituximab (Rituxan), another type of biologic treatment that suppresses the immune system inflammatory response and is often used with anti-TNFs when anti-TNFs don't work well enough
The study was sponsored by Abbott and other drug companies.
A third study found that early control and resolution of disease activity, when achieved with RA medicines, is linked with better overall survival in those with RA affecting more than four joints.
Researchers evaluated more than 2,700 RA patients and followed them up for about nine years. Those who were in remission a year after the first assessment had the biggest reduction in death risk, about 25% or more.
RA, Biologics, & Shingles Risk
For the shingles study, Helene Che of the Lapeyronie Hospital in Montpellier re-evaluated 22 published studies and 28 abstracts.
Patients were on DMARDs and biologics.
Those on anti-TNFs had a 75% higher risk of getting shingles than those on DMARDs.
Perspectives on Biologics for RA
The studies about heart attack prevention and better survival are confirming previous research, says Patience White, MD, vice president for public health at the Arthritis Foundation. She reviewed the findings for WebMD.
The research is also "confirming that remission, which we can do with these new biologics, is really important, not only in improving joint pain and disability but now for death risk," she says.
Vivian Bykerk, MD, a rheumatologist at the Hospital for Special Surgery in New York, also reviewed the findings. She put the shingles risk in perspective.
While 75% may sound like a large increase, Bykerk says it "would still be less than double a small number."
Patients considering the shingles vaccine should get it before they start the anti-TNFs, she says.
Bykerk has consulted for companies that make biologics.
These findings were presented at a medical conference. They should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.
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