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Dermatological complications and safety of anti-TNF treatments
  1. Joseph F Kerbleski,
  2. Alice B Gottlieb
  1. Tufts Medical Center, Department of Dermatology, Boston, Massachusetts, USA
  1. Dr Joseph F Kerbleski, Department of Dermatology, Tufts Medical Center, 800 Washington St, Box 114, Boston, MA 02111, USA; JKerbleski{at}

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It has been reported that tumour necrosis factor (TNF) inhibitors have adverse side-effects including infections, malignancies, demyelinating disease, and induction of autoimmune conditions. Dermatological complications of anti-TNF therapy include injection site reactions, cutaneous infections, allergic rashes, psoriasis, non-melanoma skin cancer (NMSC), and rare reports of lupus-like syndrome, erythema multiforme (EM), Steven’s Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).


Currently, there are four TNF inhibitors approved by the US Federal Drug Administration (FDA): etanercept (Enbrel; Amgen, Thousand Oaks, California, USA, and Wyeth Pharmaceuticals, Philadelphia, USA), infliximab (Remicade; Centacor, Horsham, Philadelphia, USA), adalimumab (Humira; Abbott Laboratories, Abbott Park, Illinois, USA), and certolizumab pegol (Cimzia; UCB, Smyrna, Georgia, USA). They are prescribed for and have revolutionised the treatment of various immune-mediated inflammatory disorders, most notably Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA), psoriasis, psoriatic arthritis, and ankylosing spondylitis (AS). Almost 2 million patients worldwide have been treated with them since their introduction.1

Although TNF inhibitors exhibit impressive efficacy, a number of dermatological complications exist: injection site reactions, allergic rashes, cutaneous manifestations of infusion reactions, cutaneous infections, psoriasis, NMSCs, and rare lesions including lupus-like syndrome, EM, SJS, TEN, and cutaneous vasculitis. Indeed, two recent prospective studies of 289 and 150 rheumatological patients started on TNF inhibitors found that 23–25% had a dermatological complication.2 3

The following is a review of safety data based upon reports from the FDA, review articles, company data, and reports from the German Register and from the British Society for Rheumatology Biologics Register (BSRBR). Management of these reactions is presented extensively elsewhere and briefly discussed in each section, the final table, and the conclusion.


Injection site reactions occur with the use of etanercept, adalimumab and certolizumab pegol. Signs and symptoms include redness, itching, bruising, pain, swelling and/or irritation at the site of injection. These occurred more often …

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  • Competing interests: None.

  • Funding: Centocor, Amgen, Wyeth, Immune Control, Celgene, Pharmacare, Incyte, Abbott Labs, Pfizer, Novo Nordisk.

  • Speakers’ Bureau Memberships: Dr A Gottlieb is on the panels of Amgen, and Wyeth Pharmaceuticals

    Current Consulting/Advisory Board Agreements: Dr Alice Gottlieb has agreements with Amgen, Centocor, Wyeth Pharmaceuticals, Celgene, Bristol Myers Squibb, Beiersdorf, Warner Chilcott, Abbott, Roche, Sankyo, Medarex, Kemia, Celera, TEVA, Actelion, UCB, Novo Nordisk, Almirall, Immune Control, RxClinical, Dermipsor, Medacorp, DermiPsor, Can-Fite, Incyte, Pure-Tech, Magen Biosciences