A Case of Severe Transaminase Elevation Following a Single Ustekinumab Dose with Remission After Drug Withdrawal

Lovero, Roberto; Losurdo, Giuseppe; Mastromauro, Marcella; Castellaneta, N.M.; Mongelli, Antonio; Gentile, Antonietta; Leo, Alfredo Di; Principi, Mariabeatrice

doi:10.2174/1574886313666180719165212

Cited by 8 publications

(11 citation statements)

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“…In the PHOENIX I and II studies, normal transaminase values In PHOENIX I and II, normal transaminase values were always recorded in enrolled patients [ 5 ]. A similar case was reported by Lovero R in 2018, it was a major cytolysis following UST infusion [ 6 ]. The etiological investigation was negative.…”

Section: Discussionsupporting

confidence: 77%

“…The liver biopsy showed a lymphocytic infiltration, cholangitis and piecemeal necrosis. The diagnosis retained was that of treatment-induced liver damage without HAI [ 6 ]. Spontaneous improvement of liver function after 6 months of treatment was observed without recourse to corticosteroids and without recurrence, contrary to our case [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

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Ustekinumab-induced autoimmune hepatitis: about a case report

Samah¹,

Ruth²,

Roua³

et al. 2023

Pan Afr Med J

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Ustekinumab is a fully human monoclonal antibody that binds to interleukin (IL)-12/23. Ustekinumab-related liver injury (UST) is rare. There is limited data available on the potential for ustekinumab-liver interaction. We report the case of a patient from our institution followed for colitis ulcerative who developed autoimmune hepatitis (AIH) during treatment with ustekinumab. The diagnosis of autoimmune hepatitis was retained on the simplified criteria for autoimmune hepatitis. Therapeutic management consisted of stopping ustekinumab and starting corticosteroids and immunosuppressants, with regression of cytolysis at 2 months. The purpose of the article is to alert readers and encourage them to report similar cases for better knowledge of the drug.

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Section: Discussionsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Ustekinumab-induced autoimmune hepatitis: about a case report

Samah¹,

Ruth²,

Roua³

et al. 2023

Pan Afr Med J

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“…In many studies, liver injury and increased transaminase values in patients treated with UST were uncommon [82]. Nevertheless, one case of severe transaminases elevation was reported in the literature [83]. Furthermore, the higher probability of developing respiratory complications with IFX, especially dyspnea, could be due to the infusion-related reactions [20].…”

Section: Discussionmentioning

confidence: 99%

Safety Profile of Biologics Used in Rheumatology: An Italian Prospective Pharmacovigilance Study

Cicala

Cutroneo

Gerratana

et al. 2020

JCM

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Post-marketing surveillance activities are essential to detect the risk/benefit profile of biologic disease-modifying antirheumatic drugs (bDMARDs) in inflammatory arthritis. The aim of this study was to evaluate adverse events (AEs) in patients treated with bDMARDs in rheumatology during a prospective pharmacovigilance study from 2016 to 2018. Descriptive statistical analyses were performed to evaluate bDMARDs-related variables of patients without AEs/failures vs patients with AEs and failures. The risk profile among biologics was assessed by comparing patients treated with each bDMARD to patients treated with etanercept. A total of 1155 patients were enrolled, mostly affected by rheumatoid arthritis (46.0%). AEs and failures were experienced by 8.7% and 23.3%, respectively. The number of comorbidities significantly influenced the onset of AEs, while anxiety-depressive, gastrointestinal disease, and fibromyalgia influenced onset of failures. The probability of developing an AE was significantly lower in patients treated with secukinumab, while the probability of developing treatment failure was significantly lower in patients treated with golimumab, secukinumab and tocilizumab. A total of 216 AEs were reported (25.5% serious), mostly regarding infections (21.8%), musculoskeletal (17.6%) and skin (16.2%) disorders. Serious AEs included neutropenia (12.7%), lymphocytosis (9.1%) and uveitis (7.3%). The obtained results revealed known AEs but real-world data should be endorsed for undetected safety concerns.

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“…A small retrospective study including 44 patients with psoriasis treated with ustekimumab described cases of mild elevation of liver enzymes and no cases of severe DILI[ 126 ]. Some case reports described spontaneous regression of liver injury after ustekinumab withdrawal[ 127 ].…”

Section: Ibd and Drug-induced Liver Injurymentioning

confidence: 99%

Liver involvement in inflammatory bowel disease: What should the clinician know?

Losurdo¹,

Brescia²,

Lillo³

et al. 2021

WJH

Self Cite

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Inflammatory bowel disease (IBD) may show a wide range of extraintestinal manifestations. In this context, liver involvement is a focal point for both an adequate management of the disease and its prognosis, due to possible serious comorbidity. The association between IBD and primary sclerosing cholangitis is the most known example. This association is relevant because it implies an increased risk of both colorectal cancer and cholangiocarcinoma. Additionally, drugs such as thiopurines or biologic agents can cause drug-induced liver damage; therefore, this event should be considered when planning IBD treatment. Additionally, particular consideration should be given to the evidence that IBD patients may have concomitant chronic viral hepatitis, such as hepatitis B and hepatitis C. Chronic immunosuppressive regimens may cause a hepatitis flare or reactivation of a healthy carrier state, therefore careful monitoring of these patients is necessary. Finally, the spread of obesity has involved even IBD patients, thus increasing the risk of non-alcoholic fatty liver disease, which has already proven to be more common in IBD patients than in the non-IBD population. This phenomenon is considered an emerging issue, as it will become the leading cause of liver cirrhosis.

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A Case of Severe Transaminase Elevation Following a Single Ustekinumab Dose with Remission After Drug Withdrawal

Cited by 8 publications

References 0 publications

Ustekinumab-induced autoimmune hepatitis: about a case report

Ustekinumab-induced autoimmune hepatitis: about a case report

Safety Profile of Biologics Used in Rheumatology: An Italian Prospective Pharmacovigilance Study

Liver involvement in inflammatory bowel disease: What should the clinician know?

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