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As Use of Biologicals Rises, So Too Will Cutaneous Reactions to Them: Presented at AAAAI

By Maggie Schwarz

PHILADELPHIA -- March 24, 2008 -- Serious cutaneous reactions to biological agents are rare but can be expected to increase along with use of these medications, according to a presentation made here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

Anthony A. Gaspari, MD, Shapiro Professor and Chairman, Department of Dermatology, University of Maryland School of Medicine, Collegeville, Maryland, urged physicians to become familiar with common and rare cutaneous toxicities of these agents, which are being used increasingly to treat a variety of inflammatory and autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and psoriasis.

Dr. Gaspari said that biologicals are also used off label for a number of dermatological diseases. Nearly 1 billion patients have been treated with infliximab, nearly 500,000 with etanercept, and about 200,000 with adalimumab.

Dr. Gaspari said that quantification of toxicities of antitumor necrosis factor (anti-TNF) agents is difficult because reporting is anecdotal and hard to identify, comorbidities and concomitant medications are often unreported, background rates of infection in healthy and disease-affected populations are unknown, large registries are in the process of being established, and no reliable laboratory assessment of immunocompetency is available.

Anti-TNF-induced skin changes include possible hypersensitivity reactions, autoimmune/immune dysfunction and miscellaneous skin changes, Dr. Gaspari said in a workshop on March 15.

The incidence of injection-site reactions with etanercept in clinical trials of patients with rheumatoid arthritis was 20% to 40%. The reactions are not dose limiting and incidence decreases over time. With adalimumab, injection-site reactions are estimated to occur in 20% of patients. These reactions are of concern because they are likely mediated by immunoglobulin E (IgE) and IgE response may increase over time, increasing the risk of anaphylaxis.

Vasculitis affects all age groups equally, can occur at any time, and tends to occur on the lower extremities. Treatment of vasculitis consists of corticosteroids and antihistamines, as well as discontinuing the anti-TNF medication. The TNF inhibitor can be restarted, Dr. Gaspari said.

Drug-induced systemic lupus erythematosus is also rare, has occurred mostly in women in their 50s with rheumatoid arthritis, and almost always resolves with discontinuation of the TNF inhibitor.

Disseminated and life-threatening fungal infections have been reported with anti-TNF monotherapy and when combined with other immunosuppressive medications.

Psoriasis has been reported with anti-TNF agents in patients without prior psoriasis. Patients are female at a ratio of 3:1, and onset is typically at more than 12 weeks of therapy.

Interstitial granulomatous dermatitis has also been reported, and it is been remitted completely on withdrawal of the TNF inhibitor.

Dr. Gaspari concluded that, although injection-site reactions are the most common cutaneous effects of biological agents and serious cutaneous reactions are rare, physicians must become familiar with common and rare toxicities of TNF inhibitors.


[Presentation title: Drug Eruptions From Biologics.]

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