THU0215 Hepatitis B Virus Infection Status of Patients with Spondyloarthritis During and After a Biosimilar of Tumor Necrosis Factor-α Antagonists Therapy
Authors: Y.-H. Li, Y.-Q. Mo, J.-J. Liang, D.-H. Zheng, L. Dai
Journal: Annals of the Rheumatic Diseases (2015)

<h3>Background</h3> Recent studies showed that positive rate of HBsAg was 19–24% in Chinese spondyloarthritis (SpA) patients. Since biosimilar of TNF-α antagonists such as TNF-α recptor II: IgG Fc fusion protein (TNFR: Fc) can be paid partly by Chinese medical insurance and is much cheaper than other TNF-α antagonists, TNFR: Fc is the most widely used in Chinese SpA patients. However, little is known about the influence of TNFR: Fc on HBV infection status in SpA patients with different HBV infection status. <h3>Objectives</h3> To investigate the influence of TNFR: Fc on HBV reactivation and liver function in SpA patients with chronic or past HBV infection. <h3>Methods</h3> Patients with active SpA were enrolled from Dec 2013 to Aug 2014. HBV infection was screened at baseline. All patients were treated with TNFR: FC (50mg/w, at least 12 weeks) plus Salazosulfadimidine (SSZ), thalidomine, and/or methotrexate (MTX). Antiviral prophylaxis was recommended for HBsAg+ patients. Clinical inflammatory indexs, HBV biomarkers, HBV-DNA load and liver function were evaluated at 4th, 12th, 24th week. HBV reactivation was defined as a 10-fold rise of HBV-DNA compared to baseline or switch from undetectable to detectable or HBsAg/HBeAg seroconversion from negative to positive. <h3>Results</h3> (1) Among 81 patients enrolled, 85% (69/81) were male, age (median and IQR, similarly hereinafter) was 27 (21–33) years, disease duration was 36 (8–84) months, ESR was 42 (17–68) mm/H, CRP was 21 (9–35) mg/L, and SAA was 51 (10–158) mg/L at baseline. 21% (17/81) received TNFR: FC monotherapy. (2) Patients with active SpA were divided into chronic HBV infection group (HBsAg and/or HBV-DNA +, n=21), past HBV exposure group (HBcAb or HBeAb + but HBsAg or HBV-DNA -, n=25), and free of HBV infection group (only HBsAb + or all the serum HBV biomarkers -, n=35). There was no significant difference of the change of ESR, CRP, SAA and transaminases before and 4, 12, 24 weeks after therapy (all P&gt;0.05). Each group has 1 case of transaminases elevated to more than 2-times upper limit of normal (ULN) at 12th week. And 2 patients9 transaminases elevated to more than 2-times ULN at 24th week in free of HBV infection group.(3) Chronic HBV infection group (n=21) were divided into negative HBV-DNA subgroup (HBV-DNA load less than 500 copies/ml, n=8) and positive HBV-DNA subgroup (n=13) according to HBV-DNA load. In negative HBV-DNA subgroup, 3 patients developed HBV reactivation with normal aminotransferases, and one of them received antiviral prophylaxis. In positive HBV-DNA subgroup, the baseline HBV-DNA load was 2.95×10<sup>3</sup>–5.07×10<sup>8</sup>copies/mL, 5 patients received antiviral prophylaxis and one of them developed HBV reactivation with normal aminotransferases. The patient received antival drug lamivudine (LMF) in baseline, and the HBV-DNA load reduced to normal but reparidly elevated to 1.6×10<sup>6</sup>copies/mL at 24th week with resistance to LMF, the HBV-DNA load returned to normal 20 weeks after combination with LMF and adefovir. <h3>Conclusions</h3> Liver function should be monitored during TNFR: FC therapy regardless of HBV infection status and HBV-DNA load should be monitored closely for SpA patients with HBV infection during and after TNFR: FC therapy. <h3>Disclosure of Interest</h3> None declared