FRI0314 Safety of the Newer Biological Dmards, TOCILIZUMAB and Abatacept, in Rheumatoid Arthritis (RA) Patients with A History of HBV Infection: A REAL Life Experience. (10th June 2014) - De Nard, F.
Abstract : Background: HBV infection represents a major issue in RA patients undergoing biological disease-modifying anti-rheumatic drugs (bDMARDs) treatment (1). While several studies deal with the risk of hepatitis reactivation under anti-TNF agents, there is limited experience with newer drugs as tocilizumab (TCZ) and abatacept (ABA) (2). Objectives: To assess the risk of hepatitis B reactivation in real-life RA patients undergoing treatment with ABA and TCZ. Methods: RA patients with a history of HBV infection ("HBV chronic inactive carriers" with HBsAg+ and undetectable or <2, 000 IU/mL viral load + normal liver function tests and "occult carriers" with only HBcAb+) and treated with ABA or TCZ have been retrospectively analyzed for the risk of "viral re-activation" (increase in HBV DNA>1 log10 IU/mL or detection of previously undetected HBV DNA) and/or "viral hepatitis B" (increase in aminotransferases, increase in serum HBV-DNA, presence of necroinflammation and/or fibrosis in liver biopsy) by regularly detecting HBsAg, HBV viral load, aminotransferases throughout follow-up visits (at 6, 12 and 18 months). Results: Out of 125 RA patients consecutively treated with ABA or TCZ at a single center, 17 (13, 6%) were HbcAb-pos: 16 occult carriers (8 treated with ABA+8 with TCZ), and 1 chronic inactive carrier treated with ABA. Patients were followed for a median (IQR) of 1.2 (0.7-1.5) years. They were previously treated with a median (IQR) number of 1 (1-2) synthetic DMARDs (sDMARDs) and 0 (0-1) bDMARDs. The mean age (sd) was 54.7 (16.3) years, the median disease duration was 5.8 (1.8-7.5) years. Most patients in both groups were treated with concomitant methotrexate (8/9 in the ABA, 5/8 in the TCZ group) and low dose corticosteroids. In the ABA group, 1 patient with comorbid HCV chronic infection (HCV-RNA+) started lamivudine for aminotransferases elevation (less than 2-fold ULN) occurring 2 months after ABA initiation, with a gradual amelioration of lab levels along with undetectable viral load throughout the follow-up. 2 patients (1 occult carrier and 1 chronic inactive carrier) underwent lamivudine before ABA with no adverse events related to HBV, whilst among the other 6 patients not receiving antiviral prophylaxis only 1 experienced positivization of viral load under the cut-off limit for viral reactivation (85 UI/mL) without aminotransferases elevation at 12 months. In the TCZ group, no patient received antiviral prophylaxis without hepatitis B reactivation. Conclusions: Despite limited to few patients and short follow-up, use of ABA and TCZ in RA patients with past history of HBV infection (chronic inactive/occult carrier) seems safe. However, periodic monitoring of liver function tests and viral load is mandatory. Viral prophylaxis might be considered mainly in patients undergoing ABA, according to scientific literature too. Further data are needed to fully clarify long-term safety issues. References: Vassillopoulos D et al. Management of rheumatic disease with comorbid HBV or HCV infection. Nat Rev Rheumatol 2012; 8(6):348-57. Kim PS et al. Safety and efficacy of abatacept in eight rheumatoid arthritis patients with chronic hepatitis B. Arthritis Care Res 2012; 64(8):1265-8. Disclosure of Interest: None declared DOI: 10.1136/annrheumdis-2014-eular.5021