Background 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.
Objectives To investigate the influence of TNFR: Fc on HBV reactivation and liver function in SpA patients with chronic or past HBV infection.
Methods 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.
Results (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>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 patients' 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 2.95×103–5.07×108copies/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 1.6×106copies/mL at 24th week with resistance to LMF, the HBV-DNA load returned to normal 20 weeks after combination with LMF and adefovir.
Conclusions 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.
Disclosure of Interest None declared
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.