Biologic non-TNF inhibitors increase HBV reactivation risk in rheumatic diseases
Patients with rheumatic diseases who have a history of hepatitis B virus and who are receiving treatment with non-TNF inhibitor biologic therapies are at risk for hepatitis B virus reactivation, and may need to be monitored, according to findings published in Clinical and Experimental Rheumatology.
“This was the first study to directly compare non-anti-TNF biologic agents, as a group, with anti-TNFs in terms of risk for HBV reactivation in patients with past HBV infection,” Antonis Fanouriakis, MD, of the University Hospital of Heraklion, in Greece, told Healio Rheumatology. “In patients with the latter, optional means of protection from HBV reactivation is not clear.”
To analyze the safety of non-TNF inhibitor biologics compared to TNF inhibitors among patients with a history of HBV in a real clinical setting, the researchers conducted a retrospective cohort-based study at the University Hospital of Heraklion. They identified 101 patients with previous HBV who had received a non-TNF inhibitor biologic from 2003 to 2016 for treatment of rheumatic diseases. Previous HBV was defined as serologic evidence of past exposure to the disease, including those who were HbsAg(-), anti-HBc(+), anti-HBs(±) at baseline.
Among the patients who received non-TNF inhibitor biologics, 39 were treated with abatacept (Orencia, Bristol-Myers Squibb), 32 received rituximab (Rituxan, Genentech) and 30 were given tocilizumab (Actemra, Genentech). A total of 111 patients with previous HBV who were treated with TNF inhibitors were identified to act as a control group.
According to the researchers, two patients in the non-TNF inhibitor group experienced HBV activation after a median period of 24 months. One of the patients, who was treated with abatacept, was successfully treated for HBV with entecavir. However, the other patient, who received rituximab and had prior exposure to cyclophosphamide, died. No patients in the TNF inhibitor group experienced HBV reactivation. In addition, patients in the non-TNF inhibitor group demonstrated significantly reduced anti-HBs titers relative to baseline (P = .03).
“Anti-TNF agents appear to be safe in patients with past HBV infection,” Fanouriakis said. “On the other hand, two cases of HBV reactivation with abatacept and rituximab, in patients with positive anti-HBs antibodies at baseline, may suggest that certain newer biologic agents may be accompanied by a higher risk of HBV reactivation. Until more data are available, a decision to monitor or prophylactically treat a patient with past HBV infection under biologic agents should be taken on an individualized basis.” – by Jason Laday
Disclosure: The researchers report no relevant financial disclosures.