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THU0217 Safety of Infliximab Therapy in HbsAg Carriers with Rheumatoid Arthritis: A Prospective Study
  1. L. Fang1,
  2. Y. Pan1,
  3. X. Guo1,
  4. X. Guo1,
  5. Z. Liao1,
  6. Z. Lin1,
  7. J. Gu1
  1. 1Rheumatology Division, 3rd Hospital of Sun Yat-Sen University, Guangzhou, China

Abstract

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 anti-TNF agents are more available and affordable in developing countries, the safety of anti-TNF therapy in terms of reactivation of hepatitis B infection needs more concern. No data from a prospective study focus on the use of TNF antagonists in patients with concurrent rheumatoid arthritis (RA) and HBV infection is available by now.

Objectives To evaluate the influence of infliximab on reactivation of HBV infection in HBsAg carriers with RA.

Methods In this 52 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 infliximab (5mg/kg) and a low dose concomitant MTX (10-12.5mg). Lamivudin were prescribed preventively regardless of individual viral load. Pre-existing 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 Nine female patients were recruited. At baseline, three patients (group 1) had increased viral load (4.3e4, 3.6e8, 5.6e5 copy/ml, respectively), and the other six patients (group 2) had normal viral load (<100 copy/ml). Only one patient from group 2 discontinued infliximab at week 6 due to ineffectiveness.

Reactivation of hepatitis B occurred in one patient from group 1. At week 28, the patient (baseline viral load 5.6e5) underwent a mild increase of both ALT and AST (69 and 58 IU/L, respectively). A elevated viral load (8.9e8) and a HBV YMDD mutant were also found. The infliximab treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 12 weeks and remained normal. In the other two patients from group 1 and all patients from group 2, no significant increase of AST/ALT or viral load was seen during the 52 weeks follow-up.

Conclusions A aggressive Infliximab + MTX 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-TNF 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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