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Risk of Hepatitis B Reactivation in Patients with Psoriasis on Ustekinumab

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Abstract

Background and Objectives

Ustekinumab is used to treat moderate-to-severe psoriasis by blocking the interleukin-12/23 pathway, which is also essential against intracellular pathogens. Because there is a high prevalence of hepatitis B viral infection in Taiwan, the expected risk of reactivation is higher among ustekinumab-treated patients. We performed this study to investigate the risk of hepatitis reactivation.

Subjects and Methods

Patients with psoriasis treated with ustekinumab from October 2011 to June 2016 were enrolled in a prospective cohort study. All patients were tested for hepatitis B serology and serum viral DNA at baseline. For those positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibodies (anti-HBc) testing for HBV DNA was conducted at least annually. An increase of HBV DNA > 2 log scale or emergence of HBV DNA were defined as reactivation. The primary outcome of this study was HBV reactivation.

Results

Ninety-three psoriasis patients receiving ustekinumab were included. The average duration of treatment and follow-up was 24 ± 12 months. There were 39 patients classified as naïve to HBV or vaccinated, and none of these patients had HBV reactivation. Among the remaining 54 patients classified as inactive HBV carriers, resolved HBV infection, or isolated anti-HBc positivity, only 3 patients experienced virologic reactivation, and none had liver failure.

Conclusion

The study outcomes indicate that ustekinumab could be safe for psoriasis patients since none developed persistent hepatitis or acute liver failure during therapy. However, the re-appearance of plasma HBV DNA requires appropriate monitoring of HBV viral load during ustekinumab treatment.

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Authors and Affiliations

  1. Department of Dermatology, Chang Gung Memorial Hospital, Linkou, No 5, Fuxing Street, Guishan District, Taoyuan, 333, Taiwan

    Sze-Wen Ting & Yu-Huei Huang

  2. Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Taoyuan, Taiwan

    Yi-Cheng Chen

  3. School of Medicine, Chang Gung University, Taoyuan, Taiwan

    Sze-Wen Ting, Yi-Cheng Chen & Yu-Huei Huang

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  1. Sze-Wen Ting
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Correspondence to Yu-Huei Huang.

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Conflict of interest

Sze-Wen Ting, Yi-Cheng Chen, Yu-Huei Huang declare that they have no conflict of interest.

Funding

All authors received no funding for the conduct of this study or the preparation of manuscript. This study was supported by Chang Gung Memorial Hospital, Linkou (CMRPG 1F0061, 1F0062 and MOST 104-2314-B-182A-082).

Ethic approval

The study protocol was approved by the Institutional Review Board (IRB) of the hospital (IRB approval number: 201701282B0).

Informed consent

The need for informed consent was waived by the IRB in study hospital because of the lack of different interventions among the patient groups and the lack of any breach of patient privacy.

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Ting, SW., Chen, YC. & Huang, YH. Risk of Hepatitis B Reactivation in Patients with Psoriasis on Ustekinumab. Clin Drug Investig 38, 873–880 (2018). https://doi.org/10.1007/s40261-018-0671-z

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  • DOI: https://doi.org/10.1007/s40261-018-0671-z

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