Risk of hepatitis B virus reactivation following treatment with abatacept: A retrospective study of international pharmacovigilance databases

Wang, Jingjing; Zhang, Xin; Geng, Xiaozhen; Shi, Juanjuan; Jia, Xiaoli; Dang, Shuangsuo; Wang, Wenjun

doi:10.1016/j.eclinm.2022.101425

Cited by 10 publications

(3 citation statements)

References 35 publications

(62 reference statements)

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“…Reynolds and Zen et al identified the possibility of hepatitis in patients receiving CTLA-4 inhibitors. 48 , 49 A study conducted between January 1, 2006, and June 30, 2021 collected a total of 77,669 adverse events with abatacept and 2889 reports of hepatitis B virus reactivation (HBVr) with other drugs, 50 based on the use of the FDA Adverse Event Reporting System (FAERS) database. All 55 cases taking abatacept reported serious adverse events, including 6 hospitalizations and 4 deaths.…”

Section: T-cell-targeted Drugsmentioning

confidence: 99%

Research on Liver Damage Caused by the Treatment of Rheumatoid Arthritis with Novel Biological Agents or Targeted Agents

Zhao¹,

Zhang²,

An³

et al. 2023

JIR

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Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by polyarticular, symmetric, and aggressive inflammation of the small joints in the hands and feet, resulting in dysfunction. With progress and development in medicine, treatment of RA is constantly evolving, making several drugs available for the treatment of RA. From the nonsteroidal anti-inflammatory drugs (NSAIDs) at the start of illness to glucocorticoids and then to conventional synthetic DMARDs (csDMARDs), biologic DMARDs (bDMARDs), and targeted synthetic DMARDs (tsDMARDs), therapeutic-use drugs for RA have been keeping pace with scientific research. However, various types of drugs have additional side effects when used over the long-term. New and emerging biological and targeted agents have been widely applied in recent years; however, the side effects have not been thoroughly investigated. In this paper, we review the research progress on liver damage caused by novel biological and targeted agents available for RA treatment. The aim is to provide a reference for rational clinical administration of such drugs.

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Section: T-cell-targeted Drugsmentioning

confidence: 99%

Research on Liver Damage Caused by the Treatment of Rheumatoid Arthritis with Novel Biological Agents or Targeted Agents

Zhao¹,

Zhang²,

An³

et al. 2023

JIR

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“…Abatacept has been reported to induce HBV reactivation, although its incidence has been inconsistent due to limited studies. 6,18,24 Six previous studies, that included 138 patients with resolved HBV infection who did not receive nucleoside analogue (NA) prophylaxis, found that only 10 patients experienced HBV reactivation during abatacept treatment, with varying incidence rates across the studies (ranging from 0% to 10.3%). 18,20,[25][26][27][28] Two large studies reported relatively high reactivation rates.…”

Section: Status a N = 27mentioning

confidence: 99%

HBV reactivation in HBsAg−/HBcAb+ rheumatoid arthritis patients receiving biologic/targeted synthetic DMARDs

Kuo,

Tseng,

et al. 2023

Liver International

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BackgroundRheumatoid arthritis (RA) patients seropositive for hepatitis B core antibody (HBcAb) and negative for hepatitis B surface antigen (HBsAg) are at risk of hepatitis B virus (HBV) reactivation when treated with biologic or targeted synthetic (b/ts) disease‐modifying antirheumatic drugs (DMARDs). The study aims to investigate the risk in this population.MethodsFrom January 2004 through December 2020, 1068 RA patients undergoing b/tsDMARDs therapy and 416 patients with HBsAg−/HBcAb+ were enrolled. Factors associated with HBV reactivation were analysed.ResultsDuring 2845 person‐years of follow‐up, 27 of 416 (6.5%,9.5 per 1000 person‐years) patients developed HBV reactivation, with a cumulative rate of HBV reactivation of 3.5% at 5 years, 6.1% at 10 years and 24.2% at 17 years. The median interval from beginning b/tsDMARDs to HBV reactivation was 85 months (range: 9–186 months). The risk of HBV reactivation varied by type of b/tsDMARD, with rituximab having the highest risk (incidence rate: 48.3 per 1000 person‐years), followed by abatacept (incidence rate: 24.0 per 1000 person‐years). In multivariate analysis, rituximab (adjusted hazard ratio [aHR]: 15.77, 95% confidence interval [CI]: 4.12–60.32, p = .001), abatacept (aHR: 9.30, 1.83–47.19, p = .007), adalimumab (aHR: 3.86, 1.05–14.26, p = .04) and negative baseline HBV surface antibody (anti‐HBs, <10 mIU/mL) (aHR: 3.89, 1.70–8.92, p < .001) were independent risk factors for HBV reactivation.ConclusionHBsAg−/HBcAb+ RA patients are susceptible to HBV reactivation during b/tsDMARD therapy. Those with negative baseline anti‐HBs and those on certain b/tsDMARDs, such as rituximab, abatacept and adalimumab, have high reactivation risks. Risk stratification and management should be based on the patient's baseline anti‐HBs titre and type of therapy.

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“…Недавно опубликована самая крупная на сегодняшний день серия случаев HBV-р, развившейся при применении АБА. Данные случаи демонстрируют, что терапия АБА связана не только с относительно высокой частотой HBV-р, но и нередко с риском серьезной или даже смертельной HBV-р [37]. Особым случаем является последовательное получение нескольких препаратов из групп высокого риска.…”

Section: клинический случайunclassified

Reactivation of Chronic Hepatitis B in a Patient with Rheumatoid Arthritis

Гриднева¹,

Белов²,

Аронова³

2023

EPh

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The problem of hepatitis B reactivation in patients with rheumatology profile has been and remains relevant due to the widespread use of various immuno-suppressive drugs. As new drugs are introduced into practice, there is a need to clearly understand the likelihood of HBV reactivation and personalize the management of such patients. A case of reactivation of HBV infection in a patient treated with upadacitinib and prophylactic with entecavir is presented. This review briefly summarizes the latest data on the mechanisms of HBV reactivation and the relative frequency of HBV reactivation, associated with various antirheumatic drugs

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Risk of hepatitis B virus reactivation following treatment with abatacept: A retrospective study of international pharmacovigilance databases

Cited by 10 publications

References 35 publications

Research on Liver Damage Caused by the Treatment of Rheumatoid Arthritis with Novel Biological Agents or Targeted Agents

Research on Liver Damage Caused by the Treatment of Rheumatoid Arthritis with Novel Biological Agents or Targeted Agents

HBV reactivation in HBsAg−/HBcAb+ rheumatoid arthritis patients receiving biologic/targeted synthetic DMARDs

Reactivation of Chronic Hepatitis B in a Patient with Rheumatoid Arthritis

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