Strong Safety Profile for Risankizumab in Psoriasis Patients with Hepatitis B, C Infection

Article

A new research letter highlighted findings that show a lack of viral reactivation in hepatitis patients with psoriasis, as well as other strong results, opening the door for new studies to confirm these findings.

Stefano Piaserico, MD

Credit: psoriasiscouncil.org

Stefano Piaserico, MD

Credit: psoriasiscouncil.org

Psoriasis patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection treated with risankizumab will likely not experience viral reactivation and may instead experience substantial reductions in liver fibrosis, according to a recent letter to the editor.1

The research explored in this letter was conducted in order to evaluate the safety of interleukin (IL)-23 inhibitors in this group of patients with HBV or HCV infection, although future large-scale prospective trials will be needed to confirm the study’s results.

Summary of Findings

  • A multicentric retrospective cohort study was conducted on psoriasis patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection treated with risankizumab.
  • No patients experienced viral reactivation or an increase in their baseline liver function tests (LFTs) during treatment, and a reduction in liver fibrosis was observed.
  • The study suggests a good safety profile of risankizumab in this group of patients, but further large-scale prospective studies are needed to confirm the results and validate the potential use of inhibiting the IL-23/17 axis to block progression of liver fibrosis.

The research included in the letter was authored by Stefano Piaserico, MD, from the Dermatology Unit at the University of Padua’s Department of Medicine (DIMED) in Italy.

“There is still some concern about the use of biologics for patients with psoriasis and concurrent hepatitis B virus (HBV) or hepatitis C virus (HCV) infection,” Piaserico and colleagues wrote. “In particular, there are scarce data regarding the safety of IL-23 inhibitors in this group of patients.”

Background and Findings

In 2019, the World Health Organization (WHO) reported over 296 million people had chronic HBV and 58 million had chronic HCV infections globally. Psoriasis drugs may affect the balance between virus replication and immune control of hosts, leading to possible viral reactivation, especially with immunosuppressive therapy use.2

The risk of such reactivation depends on the type of immunosuppressive therapy used. There is limited real-world data on the use of selective IL-23 inhibitors in those with psoriasis and viral hepatitis, and the investigators noted that there are only 7 cases of guselkumab or tildrakizumab treatment reported without virus reactivation evidence currently.

Given the scarce information on IL-23 inhibitor safety in this particular subgroup of patients with psoriasis, the investigators conducted a retrospective, multicentric cohort study on a total of 26 psoriasis patients with reported cases of HBV infection and a total of 23 with reported HCV infection given risankizumab.

Risankizumab is a humanized IgG1 monoclonal antibody, and is 1 of 3 IL-23 inhibitor drugs along with tildrakizumab and guselkumab.

The investigators monitored the study participants for liver function tests (LFTs) at baseline before then monitoring them for LFTs every 3 months afterward. The research team also performed liver stiffness measurement on 9 participants with HCV through the use of FibroScan.

The team noted that 42.3% of the 26 total patients were found to have chronic HBV infection, 30.8% were found to have a resolved infection of HBV, and 26.9% were found to have had a serology compatible with either a prior or an occult HBV infection.

The participants with chronic HBV infections were being treated with antiviral therapy, except for a single participant with undetectable HBV-DNA who was also being closely monitored through both serological and biochemical tests. Serum HBV-DNA load was found to be undetectable in patients with previous/occult and resolved HBV infection, as well as in 7 out of the 11 with cases of chronic HBV.

Throughout the follow-up period, the investigators reported that all of the participants maintained stable LFT results and HBV-DNA levels compared to their baseline levels, and none of them developed hepatocellular carcinoma while being treated with risankizumab.

The research team had 23 HCV-patients, and 56.5% had resolved HCV infection. Additionally, 10 began concomitant treatment with direct-acting antiviral drugs. All study participants achieved sustained virologic response and were stable with regard to their baseline LFTs and their HCV-RNA load.

The team also added that no participants developed hepatocellular carcinoma during risankizumab treatment. Data on liver fibrosis showed a slight but substantial decrease after a median time of risankizumab therapy.

Overall, the investigators found that among the 26 participants with HBV infections who were given risankizumab, none of them experienced viral reactivation or an increase in their baseline LFTs. This also included 1 individual who had a positive HBsAg and undetectable HBV-DNA but did not get antiviral prophylaxis.

The team also noted that there was no increase in LFTs or viral load in the HCV patients. Although the study was acknowledged as having had limitations due to its retrospective design, the results indicate risankizumab should be safe for this subset of patients.

Interestingly, the investigators added that risankizumab was shown to be associated with a slight but statistically significant reduction in liver fibrosis. Despite these results, the team note that more large-scale prospective studies will be needed to confirm these findings.

“Additional research is needed to validate the potential use of inhibiting IL-23/17 axis to block progression of liver fibrosis in chronic liver diseases,” they explained.

References

  1. Ciolfi C, Balestri R, Piaserico S, et al. Safety profile of risankizumab in the treatment of psoriasis patients with concomitant hepatitis B or C infection: a multicentric retrospective cohort study of 49 patients. J Eur Acad Dermatol Venereol. 2023 May 12. doi: 10.1111/jdv.19186. Epub ahead of print. PMID: 37170951.
  2. Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. Accountability for the global health sector strategies 2016–2021: actions for impact. Geneva: World Health Organization; 2021.
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