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

Abstract

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

Meta‐analysis: hepatitis B reactivation in patients receiving biological therapy

“…Of those remaining 27 articles which met inclusion criteria, a detailed search in their reference lists yielded 3 further studies which met the study's criteria for inclusion. In total, 29 articles 17–45 were included in this meta‐analysis (Figure 1). There was no data for vedolizumab and HBV reactivation apart from a single study, 46 and this was deemed to be not sufficient to be included in the meta‐analysis though it was included in the systematic review.…”

Hepatitis B Virus Reactivation and Mycobacterial Infections Associated With Ustekinumab: A Retrospective Study of an International Pharmacovigilance Database

“…This is classified in the high-risk group by the American Gastroenterological Association (AGA) and antiviral prophylaxis is recommended for this group (Reddy et al, 2015). For those with resolved HBV infection, previous nine studies including 85 patients showed that the anticipated incidence of HBVr using ustekinumab was 3.53% (3/85) (Chiu et al, 2013;Koskinas et al, 2013;Hayashi et al, 2014;Steglich et al, 2014;Snast et al, 2017;Almutairi and Abouzaid, 2018;Solay et al, 2018;Ting et al, 2018;Kłujszo et al, 2021), falling within the range of 1%-10%, which is classified in the moderaterisk group by AGA (Reddy et al, 2015). Close monitoring or antiviral prophylaxis is recommended for this group (Reddy et al, 2015;EASL, 2017;Terrault et al, 2018;Lau et al, 2021).…”

“…Eight studies investigating 40 patients with chronic HBV infection receiving ustekinumab uncovered 4 reactivations (10.0%) ( Chiu et al, 2013 ; Navarro et al, 2013 ; Sanz-Bueno et al, 2015 ; Raymundo et al, 2016 ; Almutairi and Abouzaid, 2018 ; Ting et al, 2018 ; Piaserico et al, 2019 ; Siegel et al, 2019 ). Regarding patients with resolved HBV, three of eighty-five patients (3.53%) treated with ustekinumab from nine studies developed reactivations ( Chiu et al, 2013 ; Koskinas et al, 2013 ; Hayashi et al, 2014 ; Steglich et al, 2014 ; Snast et al, 2017 ; Almutairi and Abouzaid, 2018 ; Solay et al, 2018 ; Ting et al, 2018 ; Kłujszo et al, 2021 ). In the current study, we detected a significant signal between ustekinumab exposure and HBVr in FAERS, providing new evidence on their association in terms of pharmacovigilance aspects.…”

“…Close monitoring or antiviral prophylaxis is recommended for this group ( Reddy et al, 2015 ; EASL, 2017 ; Terrault et al, 2018 ; Lau et al, 2021 ). Regarding the 85 patients, only 1 received preventive antiviral treatment ( Steglich et al, 2014 ), while the other 84 did not ( Chiu et al, 2013 ; Koskinas et al, 2013 ; Hayashi et al, 2014 ; Snast et al, 2017 ; Almutairi and Abouzaid, 2018 ; Solay et al, 2018 ; Ting et al, 2018 ; Kłujszo et al, 2021 ). But previous studies as well as the current study were retrospective and/or small sized.…”