Letter to the Editor
Vedolizumab-induced cholestatic liver injury
Lesión hepática colestásica inducida por vedolizumab
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It has a safety profile related to its mechanism of action, characterized by a gut-selectivity.<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">1,2</span></a> Pre-marketing data, in an analysis that included over 2800 VDZ-exposed patients only showed a 0.82% of hepatobiliary events.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> No cases of cholestasis were reported.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In this report, we describe the case of an 82-year-old man, without toxic habits and with hypertension, past hepatitis B, prostatectomy for adenocarcinoma and Parkinson's disease. He was diagnosed with severe ulcerative colitis (UC) and was treated with different therapies such as mesalazine, steroids and infliximab (IFX). The latest one was discontinued because of secondary loss of response. Two months later, VDZ was started, three doses of 300<span class="elsevierStyleHsp" style=""></span>mg intravenous infusions at weeks 0, 2 and 6.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Laboratory analysis at the beginning of the treatment showed a normal hepatic profile. Before the first maintenance session, laboratory tests showed an anicteric cholestasis, with high levels of Gamma-Glutamyl Transferase (GGT) and Alkaline Phosphatase (ALP) (GGT 948<span class="elsevierStyleHsp" style=""></span>U/L, ALP 909<span class="elsevierStyleHsp" style=""></span>U/L). Aspartate aminotransferase (AST) was 132<span class="elsevierStyleHsp" style=""></span>U/L and alanine aminotransferase (ALT) 169<span class="elsevierStyleHsp" style=""></span>U/L. The patient remained asymptomatic. He denied any change in his usual medication. Serological markers of autoimmunity were positive (presence of antinuclear (ANA) and smooth muscle antibodies (ASMA) in a titre<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>1/320). Immunoglobulin levels, other laboratory tests, abdominal ultrasound and a nuclear colangioresonance were normal. Cholestatic liver injury attributable to VDZ was assumed. The Council for International Organizations of medical Sciences (CIOMS) scale<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> classified the event as probable (score of 8), according to its likelihood to be drug-induced liver injury (DILI). Liver biopsy was not considered because of the frailty of the patient. The drug was withdrawn and ursodeoxycholic acid at a dosage of 15<span class="elsevierStyleHsp" style=""></span>mg/kg for two weeks was recommended.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The patient received oral prednisone, 50<span class="elsevierStyleHsp" style=""></span>mg/day for two weeks, that was tapered and maintained at 20<span class="elsevierStyleHsp" style=""></span>mg/day for 12 weeks, because of UC relapse. Cholestasis lasted for 8 months (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). Serum enzymes remained normal, ASMA became negative and ANA titre was 1/160 after corticosteroid cessation. No liver biochemical abnormalities have been observed after a follow-up of 2 years.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">DILI classified by the criteria of the International Consensus Conference, corresponded to a cholestatic pattern. Previous studies described few cases of hepatocellular type of DILI that obliged to interrupt VDZ. Our patient had a cholestatic liver injury, which could be explained because of his advanced age, as older patients are more prone to a cholestatic pattern of DILI.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> After a review of the published scientific literature, we have found just a single case of cholestatic liver injury attributable to VDZ.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> It should be noted that in both cases, DILI occurred after the induction therapy of VDZ. Unlike our case, it occurred in a young patient and it progressed to chronic liver injury despite prompt drug withdrawal and steroid treatment.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The main limitation of our case is the lack of a liver biopsy which was not considered because of the favorable outcome and the advanced age of the patient. Moreover, in suspected DILI cases it does not provide definitive diagnostic information in most instances.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> Our diagnostic was supported by the CIOMS scale<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> and the clinical evolution. Although ANA and ASMA were found positive, serologic markers of autoimmunity have also been described in DILI from other biological treatment, as IFX. Autoimmune hepatitis (AIH) and AIH-DILI,<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> a particular phenotype of hepatotoxicity, were not considered as alternative causes because rises in ALT and AST were mild. Although potential autoimmune etiology can not be ruled out, the history of exposure to the medication and the resolution of biochemical abnormalities without relapse, support the diagnosis of DILI.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">In conclusion, although VDZ is a safe treatment, monitoring hepatic enzymes during VDZ therapy should be recommended.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005"><span class="elsevierStyleBold">Authors’ contributions</span></span><p id="par0040" class="elsevierStylePara elsevierViewall">Rojas-Feria M. treated the patient. Rodríguez-Fernández M. collected the patient's clinical data. Rodríguez-Fernández M. and Rojas-Feria M. designed the report. Rodríguez-Fernández M., Rojas-Feria M., Castro-Fernández M. and Suárez-García E. wrote the paper.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010"><span class="elsevierStyleBold">Informed consent statement</span></span><p id="par0045" class="elsevierStylePara elsevierViewall">Consent was obtained from relatives of the patient for publication of this report.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015"><span class="elsevierStyleBold">Financial support</span></span><p id="par0050" class="elsevierStylePara elsevierViewall">None.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020"><span class="elsevierStyleBold">Conflicts of interest</span></span><p id="par0055" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Authors’ contributions" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Informed consent statement" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Financial support" ] 3 => array:2 [ "identificador" => "sec0020" "titulo" => "Conflicts of interest" ] 4 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1684 "Ancho" => 2508 "Tamanyo" => 150194 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Temporal evolution of liver-associated enzymes in the course of VDZ treatment.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The safety of vedolizumab for ulcerative colitis and Crohn's disease" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J.F. 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| Year/Month | Html | Total | |
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| 2024 October | 12 | 0 | 12 |
| 2024 September | 29 | 3 | 32 |
| 2024 August | 18 | 4 | 22 |
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| 2024 May | 18 | 4 | 22 |
| 2024 April | 16 | 4 | 20 |
| 2024 March | 10 | 5 | 15 |
| 2024 February | 7 | 6 | 13 |
| 2024 January | 17 | 0 | 17 |
| 2023 March | 2 | 12 | 14 |
