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

Authors

  • H.-Y. Chiu,

    1. Departments of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
    2. Department of Dermatology, Hsin-Chu Branch, National Taiwan University Hospital, Hsin-Chu, Taiwan
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  • C.-H. Chen,

    1. Departments of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
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  • M.-S. Wu,

    1. Departments of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
    2. Health Management Center, National Taiwan University Hospital, Taipei, Taiwan
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  • Y.-P. Cheng,

    1. Departments of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
    2. Department of Dermatology, Hsin-Chu Branch, National Taiwan University Hospital, Hsin-Chu, Taiwan
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  • T.-F. Tsai

    Corresponding author
    1. Departments of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
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  • Funding sources None
  • Conflicts of interests: T.-F.T. has conducted clinical trials or received honoraria for serving as a consultant for Wyeth Pharmaceuticals (now Pfizer Inc.), Serono International SA (now Merck Serono International), UniPharma/Biogen Idec, Novartis International AG and Janssen-Cilag Pharmaceuticals and received a speaking fee from Abbott (now Abbovie). The other authors have no conflicts of interest to declare.

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.

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