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We report on a 52-year-old woman with a history of severe seronegative rheumatoid arthritis. Several conventional therapies and biological therapy with etanercept and infliximab had been unsuccessful. In 2010 she was given golimumab subcutaneously at a monthly dose of 50 mg. She had a negative ANA titre. After 16 months of uninterrupted therapy and sustained response, she developed skin lesions on the upper trunk, back and upper extremities, which worsened on exposure to the sun. The skin biopsy was compatible with subacute lupus erythematosus. Laboratory findings included an ANA titre 1:640, negative anti-Ro/SSA and anti-DNA antibodies. Topical corticosteroid therapy proved inadequate. The patient's condition improved only after discontinuation of golimumab. The causal relationship between subacute cutaneous lupus erythematosus and golimumab is not dose-related and occurs with some delay (a typical feature of immunological adverse reactions). The association is likely, but not confirmed (because re-challenge was not performed). However, a clear improvement was noted after withdrawal. Based on this case, we hypothesized the aetiological role of golimumab-associated immunogenicity. TNF-α antagonist-induced lupus-like syndrome (TAILS) is a well-known side effect of this class of substances. The British Society of Rheumatology recommends discontinuation of the causal anti-TNF-α treatment in patients with TAILS.

Objectives: To identify all of the patients affected by chronic hepatitis C infection treated with TNF-α blockers (adalimumab, certolizumab pegol, etanercept, golimumab and infliximab) in order to evaluate the safety profile., Methods: A systematic review of the literature from January 1990 to October 2010., Results: In total, 37 publications with data on 153 patients who were treated with anti-TNF-α agents in the setting of HCV infection were found. The mean anti-TNF-α treatment duration was 11.9 months. Ninety-one patients had RA, 22 had psoriasis, 6 had Crohn's disease and 14 patients had other chronic inflammatory diseases. To date, etanercept is the biological agent that has been most extensively used in the patients with HCV infection, with only one definitely confirmed case of HCV hepatitis worsening and five suspected cases (elevation of transaminases not associated with an increase in the HCV viral load and vice versa) in 110 treated patients. Treatment with this agent resulted in stable levels of liver transaminases and a stable viral load in 74 patients, with an improvement in HCV chronic liver disease in combination with IFN-ribavirin therapy in 29 patients., Conclusions: The safety profile of anti-TNF-α agents in the setting of HCV infection seems to be acceptable, even if differences in the hepatotoxic profile are apparent between different agents. In the absence of long-term and large, controlled clinical trials a definitive statement on the safety of anti-TNF-α therapies in the setting of chronic HCV infection cannot be made.