Safety of therapies using ustekinumab in patients with psoriasis who have had hepatitis B virus infection

Biological therapies used in psoriasis treatment pose a risk of reactivation of hepatitis B virus (HBV) infection. This risk occurs not only in patients with HB surface antigen (HBsAg) (+) but also in patients with past or occult HBV infection (with negative HBsAg, positive HB core antibodies (HBcAb), and positive HBV deoxyribonucleic acid [DNA]). Ustekinumab (UST) is a biologic agent acts by blocking the IL-12/23 pathway. Thus, hindering this response may lead to HBV reactivation. UST therapy is associated with mild HBV-r risk; however, there is insufficient data to confirm that hypothesis. Herein, we present observations on the safety of UST therapy in patients with psoriasis and serologically proved past HBV infection. One-hundred and six consecutive patients with moderate to severe psoriasis treated with biological therapy between May 2013 and January 2020 were retrospectively analyzed. Out of 106 patients, there were five who reported having past HBV. Those five patients were tested for the presence of HBsAg, HBcAb, HBsAb as well as HBV DNA at baseline and at the end of the follow-up period. HBV reactivation was defined as changing of “undetectable” to “detectable” viremia. All five patients were treated with UST. Five patients in our cohort group were found to have resolved HBV infection: HBsAg (−), HBcAb (+), and HBV DNA (−); 4/5 were HBsAb (+) and 1/5 HBsAb (−). None of the patients experienced an increase in their liver function tests values and no signs of hepatitis or HBV reactivation were observed at any point during the study. All the patients were HBsAg and HBV DNA negative at the end of the follow-up period. The average treatment time was 82.4 (28, 96) weeks. The average follow-up time was 75.2 (31, 176) weeks. Based on the available literature and the results from our observations, UST therapy seems to be a safe option for patients with resolved HBV infection.

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