Rheumatoid Arthritis Drugs Tied to Skin Problems

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Rheumatoid Arthritis Drugs Tied to Skin Problems

Study Links Humira, Remicade, and Enbrel to Skin Conditions

By Miranda Hitti

WebMD Medical News Reviewed By Brunilda Nazario, MD

on Monday, April 04, 2005

April 4, 2005 -- Dutch researchers have linked a group of rheumatoid

arthritis drugs to skin problems.

HumiraHumira (adalimumab), RemicadeRemicade (infliximab), and

EnbrelEnbrel (etanercept) are mentioned in the study, which appears in

the journal Arthritis Research and Therapy.

All of those medications are biologic treatments for rheumatoid

arthritis (RA). They are a new type of treatment approacha new type of

treatment approach that inhibits TNF, a chemical made by the body to

induce inflammation. These chemical substances lead to joint

inflammation seen in RA.

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 Netherlands.

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

people.

Drug Companies Respond

" 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 Amgen.

" 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, it's in the label of all TNF inhibitors,it's in the

label of all TNF inhibitors, " 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.

SOURCES: Flendrie, M. Arthritis Research and Therapy, April 3, 2005.

News release, BioMed Central. Candace Steele, director, global public

relations, Wyeth Pharmaceuticals. Jim Bozikis, manager, pharmaceutical

public affairs, Abbott Laboratories.

http://my.webmd.com/content/Article/103/107214.htm