Long-term safety of rituximab in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection

Mitroulis, I.; Hatzara, Chrisoula; Kandili, Anna; Hadziyannis, Emilia; Vassilopoulos, Dimitrios

doi:10.1136/annrheumdis-2012-202088

Cited by 52 publications

(21 citation statements)

References 5 publications

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“…Rituximab (RTX), a monoclonal antibody directed against B‐cell marker CD20, is effective for treating B‐cell lymphoma and RA patients with inadequate response to anti‐tumor necrosis factor (TNF)‐α therapy . Although a previous study demonstrated no rHBV in RTX‐treated rheumatic patients with resolved HBV infection, rHBV has recently been recognized as a complication characterized by a seroreversion of HBsAg in HBsAg‐negative patients receiving RTX therapy . Despite these findings, there are limited data or even conflicting results on rHBV in RTX‐treated patients .…”

Section: Introductionmentioning

confidence: 99%

Reactivation of hepatitis B virus infection following rituximab treatment in HBsAg‐negative, HBcAb‐positive rheumatoid arthritis patients: A long‐term, real‐world observation

et al. 2019

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Aim: Longitudinal data of the reactivation of hepatitis B virus (rHBV) and serial serological markers or HBV-DNA has been limited. This study aimed to investigate the temporal course of rHBV development in rheumatoid arthritis (RA) patients undergoing long-term rituximab therapy. Methods: The occurrence of rHBV was examined in 157 RA patients during rituximab therapy. Serum levels of HBV surface antigen (HBsAg), HBV core antibody (HBcAb), and HBsAb were determined by electrochemiluminescence immunoassays, and viral loads by real-time polymerase chain reaction assay. Results: Among 157 patients undergoing rituximab therapy, 103 (65.6%) were HBsAg-negative and HBcAb-positive. Before rituximab therapy, 20 (19.4%) of these 103 patients were HBsAb-negative, while 83 (80.1%) were HBsAb-positive. Five (20%) HBsAb-negative patients developed rHBV after rituximab therapy. Among 83 HBsAb-positive patients, 4 (4.8%) developed rHBV. Among 9 patients with rHBV, 7 (77.7%) exhibited HBsAg seroreversion. Significant decline of HBsAb titers (mean ± SD, 296.0 ± 417.3 mIU/mL at baseline vs 187.0 ± 332.5 mIU/mL after rituximab therapy, P < 0.001) was observed in HBsAg-/HBsAb + patients. All HBsAgnegative patients who developed rHBV during rituximab therapy were characterized by baseline HBsAb titers < 100 mIU/mL and negative HBsAb at the time of rHBV.HBsAb positivity was an independent protective factor for rHBV (hazards ratio: 0.14, 95% CI: 0.03-0.62, P = 0.009). Conclusion:Baseline HBsAb positivity was a significant protective factor for rHBV in HBsAg-negative, HBcAb-positive RA patients receiving rituximab therapy. K E Y W O R D SHBsAg seroreversion, hepatitis B virus reactivation, rheumatoid arthritis, rituximab therapy

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Section: Introductionmentioning

confidence: 99%

Reactivation of hepatitis B virus infection following rituximab treatment in HBsAg‐negative, HBcAb‐positive rheumatoid arthritis patients: A long‐term, real‐world observation

et al. 2019

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“…Reports of HBV reactivation during treatment for rheumatic diseases are inconsistent. Two studies including a total of 26 HBsAg − /HBcAb + RA patients reported no HBV reactivation after RTX 13,14 . In a cohort study conducted in a regional hospital in Taiwan, approximately 9.1% of HBsAg − /HBcAb + RA patients (4/44) experienced HBV reactivation approximately 2 years after receiving RTX 15 .…”

mentioning

confidence: 99%

Moderate Risk of Hepatitis B Virus Reactivation in HBsAg−/HBcAb+ Carriers Receiving Rituximab for Rheumatoid Arthritis

Kuo

Tseng

Lee

et al. 2020

Sci Rep

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to investigate the incidence and risk factors of hepatitis B virus (HBV) reactivation in HBV surface antigen (HBsAg) − / HBV core antibody (HBcAb) + patients who underwent rituximab (RtX) therapy for rheumatoid arthritis (RA). From January 2000 through December 2017, a total of 134 RA patients with various HBV serostatuses who received RTX at Dalin Tzu Chi Hospital were screened. Finally, 50 HBsAg − /HBcAb + patients were enrolled in this retrospective study. Baseline characteristics, comedications, and the occurrence of HBV reactivation were recorded. Four HBsAg − /HBcAb + RA patients (8%; 4/50) experienced HBV reactivation after treatment with RTX. Hepatitis flare-up occurred in 2 of these 4 patients, with a fatal outcome in one. HBV reactivation occurred approximately 1-4 years after the first dose of RTX and 0.5-1.5 years after the last one. In HBsAg − /HBcAb + patients, HBV reactivation was significantly more common in those who were HBV surface antibody (HBsAb) − at baseline than in those who were HBsAb + (30% vs 4%; p = 0.02). A history of adalimumab use was associated with HBV reactivation (100% vs 39%; p = 0.02). A moderate risk of HBV reactivation was observed in HBsAg − /HBcAb + RA patients receiving RtX therapy. the reactivation may induce acute hepatitis and even death. To reduce the risk of HBV reactivation, regular monitoring of liver function is insufficient; monitoring of viral load and HBsAg or prophylaxis with antiviral therapy should be considered.

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“…Some clinical clues indicated that it may also protect patients with resolved HBV infection from HBV reactivation . Reduction of anti‐HBs titer has been reported in patients with resolved HBV infection and hematopoietic stem cell transplantation, systemic lupus erythematosus, or patients receiving rituximab or TFNI and it could precede HBV reactivation in hematological disorders . However, HBV reactivation did not occur in patients with resolved HBV infection and negative anti‐HBs in this study.…”

Section: Discussionmentioning

confidence: 48%

Short-course tocilizumab increases risk of hepatitis B virus reactivation in patients with rheumatoid arthritis: a prospective clinical observation

Chen

Jing

et al. 2017

Int J Rheum Dis

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This prospective clinical observation preliminarily indicated three-dose TCZ combined with csDMARDs might increase the risk of HBV reactivation in RA patients with chronic HBV infection, but in this study patients remained asymptomatic and had a benign outcome after antiviral treatment. To identify the exact risk of TCZ on HBV infection and the prognosis of TCZ-related HBV reactivation, further studies with larger sample sizes and fewer confounding factors are needed.

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Long-term safety of rituximab in patients with rheumatic diseases and chronic or resolved hepatitis B virus infection

Cited by 52 publications

References 5 publications

Reactivation of hepatitis B virus infection following rituximab treatment in HBsAg‐negative, HBcAb‐positive rheumatoid arthritis patients: A long‐term, real‐world observation

Reactivation of hepatitis B virus infection following rituximab treatment in HBsAg‐negative, HBcAb‐positive rheumatoid arthritis patients: A long‐term, real‐world observation

Moderate Risk of Hepatitis B Virus Reactivation in HBsAg−/HBcAb+ Carriers Receiving Rituximab for Rheumatoid Arthritis

Short-course tocilizumab increases risk of hepatitis B virus reactivation in patients with rheumatoid arthritis: a prospective clinical observation

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