Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study

Huang, Wen Nan; Wu, Yi; Lin, Ching Tsai; Chen, Yi Hsing; Chen, Der Yuan; Hsieh, Tsu‐Yi

doi:10.1136/annrheumdis-2017-211322

Cited by 69 publications

(51 citation statements)

References 10 publications

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“…Two others received NUCs and did not reactivate. Among those who had occult HBV, no reactivation was seen despite NUCs not being given 30. From these preliminary data, it seems that the risk associated with TOFA mainly occurs in carriers, less in the occult infection, whereas with RUXO, reactivation may occur also in occult.…”

Section: Obi and Janus Kinase (Jak) Inhibitorsmentioning

confidence: 78%

HBV and targeted synthetic (ts)DMARDs: what have we learned from bDMARDs and tsDMARDs?

2020

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Section: Obi and Janus Kinase (Jak) Inhibitorsmentioning

confidence: 78%

HBV and targeted synthetic (ts)DMARDs: what have we learned from bDMARDs and tsDMARDs?

2020

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“…JAK inhibition may counteract the suppressive effects of interferon α on viral replication; however, data on the effects of JAK inhibitors on HBV reactivation are limited. A recent retrospective analysis of 116 Taiwanese patients with RA treated with tofacitinib evaluated the risk of HBV reactivation over a 2-year period 23. Overall, 81 (69.8%) patients had a past HBV infection, based on patients being HBcAb+ with or without HBsAb.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of hepatitis B virus in clinical trials of baricitinib in rheumatoid arthritis

et al. 2020

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BackgroundReactivation of hepatitis B virus (HBV) replication is a well-recognised complication in patients receiving disease-modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis (RA). Limited data exist on HBV reactivation among patients with RA treated with janus kinase (JAK) inhibitors. The objective of the current study was to assess HBV reactivation in clinical trials of baricitinib, an oral selective JAK1 and JAK2 inhibitor in RA.MethodsData were integrated from four completed Phase 3 trials and one ongoing long-term extension (data up to 1 April 2017) in patients naïve to DMARDs or who had inadequate response (IR) to DMARDs including methotrexate (MTX)-IR and/or other conventional synthetic DMARD (csDMARD)-IR, or tumour necrosis factor inhibitors-IR. Within the clinical programme, baricitinib-treated patients may have received concomitant csDMARDs including MTX, or previous treatment with active comparators including MTX or adalimumab + MTX. At screening, all patients were tested for HBV surface antigen (HBsAg), core antibody (HBcAb) and surface antibody (HBsAb). Patients were excluded if they had (1) HBsAg+, (2) HBcAb+/HBsAb− (in Japan, could enrol if HBV DNA−) or (3) HBsAb+ and HBV DNA+. HBV DNA monitoring, following randomisation in the originating Phase 3 studies, was performed in Japan for patients with HBcAb+ and/or HBsAb+ at screening, and was later instituted globally for HBcAb+ patients in accordance with evolving guidance for HBV monitoring and management with immunomodulatory therapy.ResultsIn total, 2890 patients received at least one dose of baricitinib in Phase 3 (6993 patient-years exposure). Of 215 patients with baseline serology suggestive of prior HBV infection (HbcAb+) who received a post-baseline DNA test, 32 (14.9%) were HBV DNA+ at some point following treatment initiation; 8 of 215 patients (3.7%) had a single quantifiable result (≥29 IU/mL). Of these eight patients, four met the definition of reactivation of HBV (HBV DNA level ≥100 IU/mL); baricitinib was permanently discontinued in four patients, and temporarily interrupted in two patients. No patient developed clinical evidence of hepatitis and in five of eight patients, antiviral therapy was not used.ConclusionHBV reactivation can occur among RA patients treated with DMARDs, including baricitinib, with prior HBV exposure. Our data suggest that such patients should be monitored for HBV DNA during treatment and might be treated safely with the use of antiviral therapy as needed. The risk of HBV reactivation in patients with HBsAg treated with baricitinib is unknown.

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“…30 Data on the risk of HBV reactivation with tofacitinib is limited; In a study, reactivation of hepatitis B occurred in 2 of 4 HBs Ag positive patients. 34 Reactivation of HBV did not occur in any of the HBs Ag-negative/anti-HBc-positive patients. Few case reports have demonstrated fatal HBV reactivation in HBs Ag-positive patients receiving 5-10 mg/day everolimus for renal cell carcinoma and breast cancer.…”

Section: Bcr-abl Tyrosine Kinase Inhibitorsmentioning

confidence: 91%

<p>Prevention Strategies to Minimize the Infection Risk Associated with Biologic and Targeted Immunomodulators</p>

Kordzadeh-Kermani

Khalili

Karimzadeh

et al. 2020

IDR

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The introduction of biologic and targeted immunomodulators is a significant breakthrough in the therapeutic area of various fields of medicine. The occurrence of serious infections, a complication of secondary immunosuppression associated with these agents, leads to increased morbidity and mortality. Implementing preventive strategies could minimize infection-related complications and improve therapeutic outcomes. The purpose of this review is to focus on current evident approaches regarding screening, monitoring, preventing (immunization and chemoprophylaxis), and management of infections in patients who are candidates for about 70 biologic and targeted immunomodulators. Recommendations are based on relevant guidelines, especially the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document series published in 2018.

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Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study

Cited by 69 publications

References 10 publications

HBV and targeted synthetic (ts)DMARDs: what have we learned from bDMARDs and tsDMARDs?

HBV and targeted synthetic (ts)DMARDs: what have we learned from bDMARDs and tsDMARDs?

Evaluation of hepatitis B virus in clinical trials of baricitinib in rheumatoid arthritis

<p>Prevention Strategies to Minimize the Infection Risk Associated with Biologic and Targeted Immunomodulators</p>

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