An Autopsy Case of Fulminant Hepatitis in a Patient with Multiple Sclerosis Treated by Interferon-Beta-1a

Yamazaki, Yuichi; Suzuki, Aya; Hirayanagi, Kimitoshi; Tsukagoshi, Yusuke; Uehara, Ryota; Horiguchi, Kazuhiko; Ohyama, Tatsuya; Tomaru, Takuya; Horiguchi, Norio; Nobusawa, Sumihito; Ikota, Hayato; Sato, Ken; Kakizaki, Satoru; Kusano, Motoyasu; Ikeda, Yoshio; Yokoo, Hideaki; Yamada, Masanobu

doi:10.2169/internalmedicine.56.7980

Cited by 6 publications

(2 citation statements)

References 12 publications

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“…For instance, a case series described the occurrence of severe hepatitis in two patients, a 41-year-old woman and a 29-year-old woman, who were receiving glatiramer acetate [ 16 ]. Another case report described the occurrence of a fatal hepatitis in a 44-year-old woman with MS who was receiving IFN-beta-1a treatment and was admitted to a local hospital for severe icterus and liver injury [ 17 ]. Lastly, other studies have reported the occurrence of fulminant hepatitis during treatment with ocrelizumab and IFN-β plus steroids in MS patients, mainly women [ 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

Velișcu,

Liguori,

Anatriello

et al. 2023

Pharmaceuticals

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Background. Cladribine belongs to the group of disease-modifying therapies (DMTs) used to treat multiple sclerosis (MS). According to the highlights of a meeting held by the Pharmacovigilance Risk Assessment Committee (PRAC) on 14 January 2022, cladribine may be associated with the occurrence of liver injury, and thus liver function monitoring is recommended. Objectives and methods. Using data from the European spontaneous reporting database (EudraVigilance-EV), we aimed to describe the main characteristics of Individual Case Safety Reports (ICSRs) reporting cases of hepatobiliary disorders related to cladribine. The reporting odds ratio (ROR) was calculated to provide the probability of reporting hepatobiliary ICSRs among DMTs used to treat MS. Results. Overall, 118 ICSRs described the occurrence of cladribine-induced hepatobiliary ADRs. The majority of the ICSRs reported ADRs that were classified as serious (93%), and the outcome was mostly reported as “unknown” (50.8%). The most reported hepatobiliary disorders were drug-induced liver injury, abnormal hepatic function, ALT increases, liver disorders, hepatic failure, jaundice, lymphocyte count decreases, hepatotoxicity and hypertransaminasemia. The majority of cladribine-induced hepatic ADRs occurred in female patients belonging to the age group of 18–65 years. Conclusion. Considering the seriousness of cladribine-induced hepatic ADRs, a close monitoring of patients receiving this drug is highly recommended. In this context, further pharmacovigilance studies evaluating the hepatic safety profile of cladribine are strongly needed.

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Section: Discussionmentioning

confidence: 99%

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

Velișcu,

Liguori,

Anatriello

et al. 2023

Pharmaceuticals

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“…In literature, 11 case reports of acute liver failure associated with beta interferon have been published, seven of them with a final diagnosis of probable or definite autoimmune hepatitis and four with a diagnosis of DILI (but in three out of four cases, detectable autoantibodies were present). Two of them had a fatal outcome and seven underwent liver transplantation, while two recovered conservatively [41,[44][45][46][47][48][49][50][51].…”

Section: Beta Interferonmentioning

confidence: 99%

The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review

et al. 2021

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In this narrative review, we analyze pre-registration and post-marketing data concerning hepatotoxicity of all disease-modifying therapies (DMTs) available for the treatment of relapsing-remitting multiple sclerosis, including beta interferon, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, cladribine, natalizumab, alemtuzumab, and ocrelizumab. We review the proposed causal mechanisms described in the literature and we also address issues like use of DMTs in patients with viral hepatitis or liver cirrhosis. Most data emerged in the post-marketing phase by reports to national pharmacovigilance agencies and published case reports or case series. Serious liver adverse events are rare, but exact incidence is largely unknown, as are predictive factors. Unfortunately, none of the DMTs currently available for the treatment of multiple sclerosis is free of potential hepatic toxic effects. Cases of acute liver failure have been reported for beta-interferon, fingolimod, natalizumab, alemtuzumab, and ocrelizumab by different mechanisms (idiosyncratic reaction, autoimmune hepatitis, or viral reactivation). Patients with multiple sclerosis should be informed about possible hepatic side effects of their treatment. Most cases of liver injury are idiosyncratic and unpredictable. The specific monitoring schedule for each DMT has been reviewed and the clinician should be ready to recognize clinical symptoms suggestive for liver injury. Not all DMTs are indicated in cirrhotic patients. For some DMTs, screening for hepatitis B virus and hepatitis C virus is required before starting treatment and a monitoring or antiviral prophylaxis schedule has been established. Beta interferon, glatiramer acetate, natalizumab, and alemtuzumab are relatively contraindicated in autoimmune hepatitis due to the risk of disease exacerbation.

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Interferon-β-1a

2017

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An Autopsy Case of Fulminant Hepatitis in a Patient with Multiple Sclerosis Treated by Interferon-Beta-1a

Cited by 6 publications

References 12 publications

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

Hepatobiliary Adverse Reactions during Treatment with Cladribine: Analysis of Data from the European Spontaneous Reporting System

The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review

Interferon-β-1a

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