Reactions 1463, p35 - 3 Aug 2013 ★ S Tocilizumab Hepatitis (first report) and pancreatitis: case report A 62-year-old man who received tocilizumab developed hepatitis and pancreatitis. The man presented with progressive jaundice and pruritus, and was hospitalised. He had a 12-year history of rheumatoid arthritis, and had a history of inadequate response to adalimumab and infliximab. He had started treatment with tocilizumab 8 mg/kg/month about 3 months prior to presentation; his last injection had been 1 week prior to hospitalisation. Examination revealed that he was icteric, without any stigmata of chronic liver disease. His ALT level was 2296 IU/L, his AST level was 1455 IU/L and his total bilirubin level was 10.5 mg/dL. Percutaneous liver biopsy revealed acute hepatitis with ballooning hepatocyte degeneration, focal bile stasis and focal hepatocyte necrosis consistent with drug- induced hepatitis. The authors note that there was no evidence of any other cause that could explain the abnormalities in this patient. The man was treated with tapering prednisone. At discharge, his ALT level was 2203 IU/L, his AST level was 1203 IU/L and his total bilirubin level was 16.7 mg/dL. His lipase level was mildly elevated, with concern for mild pancreatitis. His transaminase levels normalised after 10 weeks, and his pancreatic enzymes normalised after 50 weeks. The authors note that given the temporal relationship of starting tocilizumab with his severe hepatitis, resolution for discontinuation of tocilizumab, negative other workup for the hepatitis and liver biopsy showing drug- induced hepatitis, this is most likely related to the tocilizumab. Author comment: "The Naranjo scale and Liverpool ADR [adverse drug reaction] causality assessment tool, which are commonly used methods to decide the likelihood of ADR, both suggested that TCZ [tocilizumab] is the probable cause of our patient’s hepatitis and a possible cause of his pancreatitis." Alfreijat M, et al. Severe hepatitis associated with tocilizumab in a patient with rheumatoid arthritis. Rheumatology 52: 1340-1341, No. 7, Jul 2013. Available from: URL: http://dx.doi.org/10.1093/rheumatology/kes397 - USA 803090801 » Editorial comment: A search of AdisBase, Medline and Embase did not reveal any previous case reports of hepatitis associated with tocilizumab. The WHO ADR database contained 7 reports of hepatitis associated with tocilizumab. 1 Reactions 3 Aug 2013 No. 1463 0114-9954/13/1463-0001/$14.95 Adis © 2013 Springer International Publishing AG. All rights reserved

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Reactions 1463, p35 - 3 Aug 2013

★ STocilizumab

Hepatitis (first report) and pancreatitis: case reportA 62-year-old man who received tocilizumab developed

hepatitis and pancreatitis.The man presented with progressive jaundice and pruritus,

and was hospitalised. He had a 12-year history of rheumatoidarthritis, and had a history of inadequate response toadalimumab and infliximab. He had started treatment withtocilizumab 8 mg/kg/month about 3 months prior topresentation; his last injection had been 1 week prior tohospitalisation. Examination revealed that he was icteric,without any stigmata of chronic liver disease. His ALT level was2296 IU/L, his AST level was 1455 IU/L and his total bilirubinlevel was 10.5 mg/dL. Percutaneous liver biopsy revealedacute hepatitis with ballooning hepatocyte degeneration, focalbile stasis and focal hepatocyte necrosis consistent with drug-induced hepatitis. The authors note that there was no evidenceof any other cause that could explain the abnormalities in thispatient.

The man was treated with tapering prednisone. Atdischarge, his ALT level was 2203 IU/L, his AST level was1203 IU/L and his total bilirubin level was 16.7 mg/dL. Hislipase level was mildly elevated, with concern for mildpancreatitis. His transaminase levels normalised after10 weeks, and his pancreatic enzymes normalised after50 weeks. The authors note that given the temporalrelationship of starting tocilizumab with his severe hepatitis,resolution for discontinuation of tocilizumab, negative otherworkup for the hepatitis and liver biopsy showing drug-induced hepatitis, this is most likely related to the tocilizumab.

Author comment: "The Naranjo scale and Liverpool ADR[adverse drug reaction] causality assessment tool, which arecommonly used methods to decide the likelihood of ADR,both suggested that TCZ [tocilizumab] is the probable causeof our patient’s hepatitis and a possible cause of hispancreatitis."Alfreijat M, et al. Severe hepatitis associated with tocilizumab in a patient withrheumatoid arthritis. Rheumatology 52: 1340-1341, No. 7, Jul 2013. Availablefrom: URL: http://dx.doi.org/10.1093/rheumatology/kes397 - USA 803090801

» Editorial comment: A search of AdisBase, Medline andEmbase did not reveal any previous case reports of hepatitisassociated with tocilizumab. The WHO ADR database contained7 reports of hepatitis associated with tocilizumab.

$TOCILIZUMAB en artritis reumatoide · FAME. Requiere infusión iv en unidades de hospital de día. Anticuerpo monoclonal humanizado recombinante anti-TNF. Indicado en AR tras fracaso$