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. 2022 Jun;42(6):525-531.
doi: 10.1007/s40261-022-01163-5. Epub 2022 May 28.

Hepatitis Virus Reactivation in Patients with Psoriasis Treated with Secukinumab in a Real-World Setting of Hepatitis B or Hepatitis C Infection

Matteo Megna  1 , Cataldo Patruno  2 , Maria Rita Bongiorno  3 , Alessio Gambardella  4 , Claudio Guarneri  5 , Paolo Romita  6 , Annunziata Raimondo  7 , Francesco Loconsole  6 , Gabriella Fabbrocini  8
Affiliations

Hepatitis Virus Reactivation in Patients with Psoriasis Treated with Secukinumab in a Real-World Setting of Hepatitis B or Hepatitis C Infection

Matteo Megna et al. Clin Drug Investig. 2022 Jun.

Abstract

Background and objective: Biologics for psoriasis, especially anti-tumor necrosis factor-α therapies, may reactivate hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, as well in inactive carriers or patients with occult infection. However, some biologics, including anti-interleukin-17 therapies such as secukinumab, seem to be less likely to cause hepatitis reactivation. This study assessed the safety of secukinumab treatment in patients with psoriasis with HBV or HBC infection.

Methods: This was a retrospective cohort study of patients with moderate-to-severe psoriasis treated with secukinumab at seven Italian centers. Patients serologically positive for one or more of the following viral hepatitis markers were included: HCV antibody (± HCV-RNA positivity) and/or hepatitis B surface antigen, and/or HBV core antibody and/or HBV surface antibody (± HBV-DNA positivity). Patients received secukinumab 300 mg subcutaneously at week 0/1/2/3/4 then every 4 weeks; prophylactic therapy before starting secukinumab was prescribed where indicated. The primary study endpoint was the reactivation of hepatitis viral infection, defined as conversion to HBV-DNA or HCV-RNA positivity, with or without elevation of transaminases.

Results: Sixty patients (17 with concomitant psoriatic arthritis) were included. Thirteen subjects were hepatitis B surface antigen positive, 19 were HBV core antibody positive, and 30 were positive for the HCV antibody; however, all were HCV-RNA negative. After 53.5 ± 37.5 weeks of secukinumab therapy, hepatitis reactivation occurred in only one patient, who had a reactivation of both hepatitis B and hepatitis C. This patient had not undergone hepatitis B prophylaxis or hepatitis C treatment before secukinumab.

Conclusions: These real-world data support the safety of secukinumab in patients with positive markers of HBV or HCV infection, when administered together with dedicated prophylaxis.

Plain language summary

In this retrospective cohort study, 60 patients with moderate-to-severe psoriasis were treated with secukinumab at seven Italian centers. Secukinumab is a fully human monoclonal antibody targeting interleukin-17A, a key cytokine associated with the development of psoriatic disease. All patients had markers of hepatitis B and/or C. Where appropriate, patients received prophylactic antiviral therapy before starting secukinumab at the standard dose for treating psoriasis in Italy. Secukinumab was administered at the labeled dose. After a mean duration treatment of 53.5 weeks, hepatitis reactivation (both B and C) occurred in one patient. This patient had not undergone hepatitis B prophylaxis or hepatitis C treatment before receiving secukinumab. The study is important, as some biologics for psoriasis, especially anti-tumor necrosis factor-α therapies, have been shown to reactivate both hepatitis B virus or hepatitis C virus infections in inactive carriers, patients with occult hepatitis B virus infection, or patients with hepatitis C virus infections. However, there is evidence that second-generation biologic therapies, including those with anti-interleukin-17 activity, are less likely to cause hepatitis reactivation. This study supports the safety of secukinumab treatment in patients with psoriasis with hepatitis B and/or C.

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Conflict of interest statement

Matteo Megna has acted as a speaker or consultant for Abbvie, Amgen, Eli Lilly, Leo Pharma, Janssen, Novartis, and UCB. Gabriella Fabbrocini has acted as a speaker or consultant for Abbvie, Almirall, Amgen, Eli Lilly, Leo Pharma, Janssen, Novartis, Sanofi, and UCB. Cataldo Patruno has acted as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Eli Lilly, Leo Pharma, Novartis, Pfizer, Pierre Fabre, and Sanofi. Claudio Guarneri has received consultation fees and/or grants for research projects and advisory panels and for giving educational lectures from Wyeth-Pfizer, Abbott Immunology-Abbvie, Janssen-Cilag, Novartis, LEO-Pharma, Ely-Lilly, Celgene, Merck-Serono, Sanofi-Aventis, Amgen, and Almirall. The other authors declare no conflicts of interest.

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