Background/Purpose: The use of immunosuppressive medications in patients with a history of hepatitis B virus (HBV) infection is associated with an increased risk of HBV reactivation which can lead to liver failure and death. Rates of HBV reactivation have been reported in up to 24% of people with resolved HBV (positive core antibody [HBcAb], negative surface antigen [HBsAg], and positive or negative surface antibody [HBsAb]) and 34% of people with chronic HBV (positive HBsAg) in patients who are treated with tumor necrosis factor inhibitors, rituximab, and other biologics. Outside of Asia, there are limited data regarding the risk of reactivation in patients taking tocilizumab or tofacitinib, both of which have emerged as potential treatments for the systemic inflammatory manifestations of coronavirus disease 2019.

Methods: In this retrospective study, we identified patients in the Mass General Brigham (MGB) healthcare system who had ≥ 1 prescription for either tocilizumab or tofacitinib and resolved or chronic HBV between 1995 and 2018. Details regarding demographics, medical history, and laboratory results were extracted from the electronic health record. HBV reactivation was defined as a greater than 10-fold increase in HBV deoxyribonucleic acid (DNA) levels from baseline, an absolute increase > 10⁵ copies/mL, or a positive HBsAg when previously negative.

Results: Twenty patients, all with resolved HBV, were included (Table 1). Four patients received tofacitinib and tocilizumab sequentially such that there were 24 medication exposures. The median age at treatment initiation was 59 years (tofacitinib) and 66 years (tocilizumab) and the majority were female. The majority of patients treated with tocilizumab (16, 100%) and tofacitinib (7, 88%) were HBsAb positive at baseline. Concurrent immunosuppression was used in 12 (75%) tocilizumab-treated patients and 6 (75%) tofacitinib-treated patients. Anti-viral treatment was prescribed in 25% of cases in both groups. Median follow-up time after treatment initiation was 4.0 years in the tocilizumab group and 3.1 years in the tofacitinib group. During follow-up, all patients had aminotransferases measured at least once, and no patients had transaminitis attributed to HBV reactivation. Among the patients who had ≥ 1 HBV polymerase chain reaction or HBsAg assessed after treatment initiation (13 [81%] in the tocilizumab group and 4 [50%] in the tofacitinib group), none were positive.

Conclusion: We found no instances of HBV reactivation in patients with resolved HBV exposed to tocilizumab or tofacitinib. A quarter of people in our study were prescribed antivirals and many had no follow up serologic studies to evaluate for reactivation, reflecting the uncertainty regarding best practices for patients with resolved HBV. Our findings suggest that tocilizumab or tofacitinib may be safely used in patients with resolved HBV infection.

Table 1. Demographics, clinical characteristics, and follow up of study population

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-use-of-tocilizumab-and-tofacitinib-in-patients-with-resolved-hepatitis-b-infection-a-case-series/