Background Prevalence rate of hepatitis B virus (HBV) infection in China (13%) and many other developing countries are much higher than that in developed countries. When more and more biologicals are more available and affordable in developing countries, the safety of anti-IL-6 therapy in terms of reactivation of hepatitis B infection needs more concern. No data from a prospective study focus on the use of IL-6 antagonists in patients with concurrent rheumatoid arthritis (RA) and HBV infection is available by now.
Objectives To evaluate the influence of tocilizumab on reactivation of HBV infection in HBsAg carriers with RA.
Methods In this 24 weeks observation, HBsAg carriers with active RA (DAS28>5.1) despite failed combined treatment with MTX and other non-biological DMARD were enrolled. Patients must have normal liver function prior to the study. All patients received therapy with tocilizumab (4-8mg/kg). Lamivudin were prescribed preventively regardless of individual viral load. Pre-existing MTX, NSAIDs and corticosteroids (a maximum prednisone-dose equivalent of 10 mg/day) were allowed. During the study, serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and HBV viral load (polymerase chain reaction) were monitored every 4 weeks. Increased viral load and abnormal liver function were managed and monitored according to expert opinion.
Results Seven female patients were recruited. At baseline, two patients (group 1) had increased viral load (5.6e4, 3.8e6 respectively), and the other five patients (group 2) had normal viral load (<100 copy/ml). Only one patient from group 2 discontinued tocilizumab at week 8 due to ineffectiveness. Reactivation of hepatitis B occurred in one patient from group 1. At week 8, the patient (baseline viral load 5.6e4) underwent a mild increase of both ALT and AST (63 and 51 IU/L, respectively). A elevated viral load (6.9e7) and a HBV YMDD mutant were also found. The tocilizumab treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 8 weeks and remained normal. In the other patient from group 1 and all patients from group 2, no significant increase of AST/ALT or viral load was seen during 24 weeks follow-up.
Conclusions A aggressive Tocilizumab therapy may be a safe option for HBsAg carriers with DMARDs refractory RA. In order to reduce the risk of reactivation of hepatitis B infection, prophylaxis strategy with more effective anti-viral drugs is recommended. Large cohorts are highly needed to further evaluate the use of anti-IL-6 agents in patients with concurrent rheumatic diseases and different HBV infection status, including inactive and active infection.
Disclosure of Interest None declared
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