Risk of Drug-Induced Liver Injury From Tumor Necrosis Factor Antagonists

Bjõrnsson, Einar; Gunnarsson, Baldvin I.; Gröndal, Gerður; Jonasson, Jón G.; Einarsdóttir, Rannveig; Lúðvíksson, Björn Rúnar; Guðbjörnsson, Björn; Ólafsson, Sigurđur

doi:10.1016/j.cgh.2014.07.062

Cited by 106 publications

(112 citation statements)

References 25 publications

(53 reference statements)

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“…Majority of these patients had autoimmune features at the time of DILI with antinuclear antibody (ANA), smooth muscle antibody (SMA) and/or histological pattern compatible with autoimmune hepatitis. In a recent study from Iceland, a total of 11 patients on anti-TNF antagonists were diagnosed with DILI, 8 females (73 %), and 9 (82 %) due to infliximab (Björnsson et al 2014). Over a 5-year period, DILI developed in 1 out of 120 treated with infliximab (IFX), 1/270 with adalimumab and 1/430 etanercept.…”

Section: Antitumor Necrosis Factor Antagonistsmentioning

confidence: 97%

Drug-induced liver injury: an overview over the most critical compounds

Bjõrnsson

2015

Arch Toxicol

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119

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There has been a substantial interest in drug-induced liver injury (DILI) recently. National Institutes of Health has sponsored a multicenter study in the USA for the last 10 years, which has collected valuable information in this context. Idiosyncratic DILI is like other adverse effects of drugs underestimated and underreported in most epidemiological studies. A recent prospective population-based study from Iceland found a crude incidence of approximately 19 cases per 100,000 and year. Antibiotic is the class of drugs most commonly implicated in patients with DILI. Amoxicillin-clavulanate continues to be the most commonly implicated agent occurring in approximately 1 out of 2,300 users. Drugs with the highest risk of DILI in the Icelandic study were azathioprine and infliximab. Although rare, statin-induced hepatotoxicity has been well documented. Liver injury associated with the use of herbal medicines and dietary supplements seems to be increasing. Information on the documented hepatotoxicity of drugs has recently been made easier by a website available in the public domain: LiverTox ( http://livertox.nlm.nih.gov ). Unfortunately, at the current time, pre-therapy risk assessment for DILI in the individual patient is difficult but previous well-documented hepatotoxicity is usually a contraindication for a subsequent treatment with the same drug.

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Section: Antitumor Necrosis Factor Antagonistsmentioning

confidence: 97%

Drug-induced liver injury: an overview over the most critical compounds

Bjõrnsson

2015

Arch Toxicol

Self Cite

119

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“…11 cases of liver injury were described also in Iceland. In 8/11 of the cases, the causality between liver damage and anti-TNF-α was highly probable [81]. In the same country, a prospective study in the general population identified 96 patients with DILI from 2010 through 2011.…”

Section: Anti-tnf-α Liver Toxicitymentioning

confidence: 99%

Harmful Effects and Potential Benefits of Anti-Tumor Necrosis Factor (TNF)-α on the Liver

Lopetuso

Mocci

Marzo

et al. 2018

IJMS

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Anti-tumor necrosis factor (TNF)-α agents represent an effective treatment for chronic inflammatory diseases. However, some concerns about their potentially undesirable effects on liver function have been reported. On the other hand, evidence of their therapeutic effects on certain liver diseases is accumulating. Many data showed the safety of anti-TNF-α in patients with chronic hepatitis B and C and in liver transplanted patients even if a strict follow-up and prophylaxis are recommended in well-defined subgroups. On the other side, anti-TNF-α-induced liver injury is not a rare event. However, it is often reversible after anti-TNF-α withdrawal. Anti-TNF-α agents have been tested in advanced stages of severe alcoholic hepatitis and non-alcoholic fatty liver disease. Limited data on the efficacy of anti-TNF-α in patients with autoimmune hepatitis and primary biliary cholangitis are also available. In this review, we explored the hepatic safety concerns in patients receiving anti-TNF-α agents with and without pre-existent hepatic diseases. In addition, the available evidence on their potential benefits in the treatment of specific hepatic diseases is discussed.

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“…As the indications for the anti-TNF-α class of medications expanded and usage became more widespread, case series were collected, further providing evidence that there was an association between TNF-α antagonists and liver injury [26]. Over the past few years, several larger studies—including queries of large databases of patients on anti-TNF-α therapy and liver injury networks—have been published, and these have helped to better characterize the liver injury patterns that are encountered [8, 27–29]. …”

Section: Reported Adverse Effects: Focus On Dilimentioning

confidence: 99%

“…Another recent study by Björnsson et al [27] described 11 cases of liver injury that were identified at the National University Hospital of Iceland (Reykjavík, Iceland). Again, the RUCAM was used to assign causality, and in the 11 cases described, the anti-TNF-α medications were felt to be causative.…”

Section: Reported Adverse Effects: Focus On Dilimentioning

confidence: 99%

Hepatotoxicity Associated with the Use of Anti-TNF-α Agents

et al. 2015

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Medications to inhibit the actions of tumour necrosis factor alpha have revolutionized the treatment of several pro-inflammatory autoimmune conditions. Despite their many benefits, several serious side effects exist and adverse reactions do occur from these medications. While many of the medications’ potential adverse effects were anticipated and recognized in clinical trials prior to drug approval, several more rare adverse reactions were recorded in the literature as the popularity, availability and distribution of these medications grew. Of these potential adverse reactions, liver injury, although uncommon, has been observed in some patients. As case reports accrued over time and ultimately case series developed, the link became better established between this family of medicines and various patterns of liver injury. Interestingly, it appears that the majority of cases exhibit an autoimmune hepatitis profile both in serological markers of autoimmune liver disease and in classic autoimmune features seen on hepatic histopathology. Despite the growing evidence of this relationship, the pathogenesis of this reaction remains incompletely understood, but it appears to depend on characteristics of the medications and the genetic composition of the patients; it is likely more complicated than a simple medication class effect. Because of this still incomplete understanding and the infrequency of the occurrence, treatments have also been limited, although it is clear that most patients improve with cessation of the offending agent and, in certain cases, glucocorticoid use. However, more needs to be done in the future to unveil the underlying mechanisms of this adverse reaction.

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Risk of Drug-Induced Liver Injury From Tumor Necrosis Factor Antagonists

Cited by 106 publications

References 25 publications

Drug-induced liver injury: an overview over the most critical compounds

Drug-induced liver injury: an overview over the most critical compounds

Harmful Effects and Potential Benefits of Anti-Tumor Necrosis Factor (TNF)-α on the Liver

Hepatotoxicity Associated with the Use of Anti-TNF-α Agents

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