The safety profile of ustekinumab in the treatment of patients with psoriasis and concurrent hepatitis B or C

• Published in: British journal of dermatology (1951) Vol. 169; no. 6; pp. 1295 - 1303
• Main Authors: Chiu, H.-Y., Chen, C.-H., Wu, M.-S., Cheng, Y.-P., Tsai, T.-F.
• Format: Journal Article
• Language: English
• Published: Oxford Blackwell Publishing Ltd 01-12-2013; Wiley-Blackwell
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - adverse effects; Antiviral agents; Biological and medical sciences; Carcinoma, Hepatocellular - complications; Dermatologic Agents - adverse effects; Dermatology; Female; Hepatitis B virus; Hepatitis B, Chronic - complications; Hepatitis B, Chronic - prevention & control; Hepatitis C, Chronic - complications; Hepatitis C, Chronic - prevention & control; Human viral diseases; Humans; Infectious diseases; Liver Neoplasms - complications; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - chemically induced; Psoriasis - complications; Psoriasis - drug therapy; Psoriasis. Parapsoriasis. Lichen; Retrospective Studies; Ustekinumab; Viral diseases; Viral hepatitis; Viral Load; Virus Activation - drug effects; Human; Skin disease; Psoriasis; Dermatology; Hepatic disease; Patient; Infection; Viral hepatitis B; Concomitant disease; Treatment; Viral disease; Digestive diseases; Safety; Viral hepatitis C
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/bjd.12461

Summary
Background
Ustekinumab, an interleukin (IL)‐12 and IL‐23 blocker, has emerged as a new therapeutic option for patients with psoriasis. It is generally well tolerated but safety data on the use of ustekinumab in patients with viral hepatitis are limited.
Objective
To assess the safety profile of ustekinumab in the treatment of patients with psoriasis who have concomitant hepatitis B or hepatitis C.
Methods
This study included 18 patients with concurrent psoriasis and hepatitis B virus (HBV) infection (14 patients) or hepatitis C virus (HCV) infection (four patients) who were treated with at least two ustekinumab injections. Viral loads were measured at baseline and each time before the administration of ustekinumab. Relevant clinical data were recorded.
Results
Among 11 patients positive for hepatitis B surface antigen (HBsAg), two out of the seven (29%) patients who did not receive antiviral prophylaxis exhibited HBV reactivation during ustekinumab treatment. No viral reactivation was observed in the three occult HBV‐infected patients (HBsAg‐negative/hepatitis B core antibody‐positive patients). One patient with HCV, liver cirrhosis and treated hepatocellular carcinoma (HCC) experienced HCV reactivation and recurrent HCC during the ustekinumab treatment. No significant increase in aminotransferase levels was observed in any patient.
Conclusions
Antiviral prophylaxis appears to minimize the risk of viral reactivation in patients with concurrent psoriasis and HBV infection. Without effective anti‐viral prophylaxis, the risk/benefit of ustekinumab treatment should be carefully assessed in patients with psoriasis and HBV or HCV infection and/or HCC. Close monitoring for HBV and HCV viral load is recommended, particularly for patients with high‐risk factors. Serum aminotransferase determination may not be useful for early detection of viral reactivation.
What's already known about this topic?
Interleukin (IL)‐12 plays a central role in mounting an immune response directed towards the elimination of pathogens.
Ustekinumab, an IL‐12/23 blocker may theoretically carry the risk of hepatitis B (HBV) and hepatitis C virus (HCV) reactivation with its use.
What does this study add?
Ustekinumab appears to be well tolerated in patients with concurrent psoriasis and HBV infection under antiviral prophylaxis.
The risk of HCV reactivation during ustekinumab treatment does exist and appropriate vigilance should be exercised, especially in specific high‐risk patient groups.