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Objectives: The aim of the study was to retrospectively evaluate the long-term safety profile of anti-tumour necrosis factor (TNF)-α agents on the liver of patients with spondyloarthritis (SpA) and a previously resolved hepatitis B virus (HBV) infection., Methods: Medical records from 992 consecutive outpatients receiving anti-TNF-α therapy between 2007 and 2015 were retrospectively reviewed. HBV infection was assessed evaluating HBV surface antigen (HBsAg), antibodies to HBsAg (anti-HBs), antibodies to hepatitis B core (anti-HBc), and HBV-DNA levels. In patients with a previously resolved HBV infection, serum levels of aminotransferase (AST/ALT) were also assessed every three months, while HBsAg and HBV-DNA every six months., Results: We identified 131 consecutive patients (70 males, 61 females) with SpA and resolved HBV infection. At baseline none of the patients were positive for HBV-DNA, and AST/ALT levels were within the normal range with no subsequent increase during the observational treatment period. None received antiviral therapy prior to or during anti-TNF drug administration. At the end of the follow-up period (75.50±33.37 months) no viral reactivation was observed in anti-HBc positive patients, regardless of anti-HBs positivity. During the whole follow-up, HBV-DNA was undetectable in all patients, HBsAg remained negative, and it was not necessary to discontinue biologic therapy because of liver damage., Conclusions: Our results confirm that pre-emptive antiviral prophylaxis may not be necessary routine, but strict monitoring for AST/ALT levels, as well as for changes in HBV serology and HBV-DNA remain necessary and seem a realistic and cost-effective approach to identify early viral reactivation.

Objectives: Rheumatoid arthritis is associated with an increased risk of adverse pregnancy outcomes. TNF inhibitors are effective in the treatment of signs and symptoms of the disease although their safety during pregnancy is debated., Methods: Two cases of women with rheumatoid arthritis in complete remission of the disease with etanercept who decided to continue the therapy throughout their pregnancy are presented. A longitudinal evaluation of the disease activity showed a satisfactory control and good pregnancy outcomes were obtained. A flare of the disease after delivery was not observed., Conclusions: Etanercept seems to be safe during pregnancy and lactation. A good control of the activity of the disease was reported throughout the pregnancy and during puerperium, when a reactivation of rheumatoid arthritis is often observed.