Rheumatoid Arthritis Drugs Tied to Skin Problems
Study Links Humira, Remicade, and Enbrel to Skin Conditions
April 4, 2005 -- Dutch researchers have linked a group of rheumatoid
arthritis drugs to skin problems.
adalimumab), (infliximab), and
mentioned in the study, which appears in the journal Arthritis Research and
All of those medications are biologic treatments for rheumatoid arthritis
(RA). They are that inhibits TNF, a chemical made by the body to induce
inflammation. These chemical substances lead to joint inflammation seen in
The study "shows that dermatological conditions are a significant and
clinically important problem in RA patients receiving TNF-alpha-blocking
therapy," write the researchers.
Out of 289 RA patients taking biologic agents, 72 (25%) consulted a
dermatologist about skin problems over an average of two years. In comparison,
in a group of RA patients who had never received these drugs, 37 (13%)
consulted a dermatologist. The comparison group tended to have less severe
cases of RA, say the researchers.
Most Common Problems
There were a total of 128 skin problems among the 72 patients taking
biologic agents who had consulted a dermatologist. Their most common conditions
were skin infections (33 cases), eczema (20 cases), and drug-related skin
eruptions (15 cases). None required hospitalization but seven patients decided
to stop taking the drugs because of skin problems.
The number of skin problems reported during or after treatment was 56 for
Humira, 49 for Remicade, and 16 for Enbrel, write the researchers, who included
Marcel Flendrie of Radboud University Njimegen Medical Centre in the
Most of the skin eruptions occurred in the first five months of treatment
with the biologic agents and were caused by all of the drugs, the researchers
report. Reports of skin problems had surfaced in study trials of the drugs but
this is the first large study that tracked problems as they unfolded, say
Flendrie and colleagues.
Who Took What Drugs
The group included 70 patients who were taking more than one TNF blocker.
Eight patients took more than two anti-TNF drugs, say researchers.
Humira was taken by 108 patients, Remicade by 167, and Enbrel by 78
"Based on the information in the article, we really can't address [the
study]," says Candace Steele, director of global public relations for Wyeth
Pharmaeuticals, which markets Enbrel in the U.S. together with the drug company
"I can tell you that we have seen dermatological effects with some
patients who've used Enbrel," says Steele. "Essentially, if a physician
were to contact us about dermatological effects, we have standard information
[stating that] skin rash has been described in clinical trials, postmarketing
experience, and literature reports."
Patients should report any skin conditions to their doctors, she adds.
"Injection site reaction is a possible side effect that's listed in our
label. In fact,
" says Jim Bozikis, manager of pharmaceutical public
affairs for Abbott Laboratories, which makes Humira.
"Our experience with RA patients and Humira is that when side effects do
occur, they're so mild that patients choose to continue therapy because the
benefits greatly outweigh any side effects," he says.
"In general, with anti-TNF therapy, patients are more susceptible to
infection and the key is for patients to work closely with their physicians and
carefully monitor their progress," says Bozikis.