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

Abstract

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. In particular, there are scarce data regarding the safety of IL-23 inhibitors in this group of patients. We performed a multicentric retrospective cohort study on 26 consecutive psoriasis patients with HBV infection and 23 patients with HCV infection treated with risankizumab. Patients were monitored for liver function tests (LFTs) at baseline and every 3 months thereafter. Liver stiffness measurement (LSM) by FibroScan was performed in 9 HCV patients. Demographic and clinical data on HBV-patients are listed in Table 1. Eleven of the 26 patients (42.3%) had chronic HBV infection, seven (26.9%) had a serology compatible with a previous or an occult HBV infection, and eight (30.8%) had resolved HBV infection.Patients with chronic HBV infection were under antiviral therapy, except for one patient with undetectable HBV-DNA who underwent only strict serological and biochemical follow-up. Serum HBV-DNA load was undetectable in all patients with previous/occult and resolved HBV infection, and in 7/11 patients with chronic HBV infection. During follow-up, all patients showed stable LFTs and HBV-DNA load with respect to baseline levels; no patients developed hepatocellular carcinoma during risankizumab treatment. Demographic and clinical data on HCV patients are listed in Table 2. Thirteen of the 23 patients (56.5%) had a resolved HCV infection with undetectable HCV-RNA after successful treatment with direct-acting antivirals. Ten patients with detectable HCV-RNA at baseline started concomitant treatment with direct-acting antiviral drugs, all achieving sustained virologic response. All patients were stable with regard to their baseline LFTs and HCV-RNA load, and no patients developed hepatocellular carcinoma during risankizumab treatment. Data on liver fibrosis were collected for nine patients, showing a slight but significant decrease of fibrosis after a median time of risankizumab therapy (mean 3.44 ± 0.88 kPa at baseline and 2.89 ± 0.78 kPa at the end of follow-up; p-value = 0.025). According to the World Health Organization's last global report, in 2019 around 296-million people and 58-million C

Management of Psoriasis Patients with Serious Infectious Diseases

“…With regard to IL-23 inhibitors, the risk of reactivation of hepatitis B and C also appears to be very low. Several real-life studies have demonstrated the safety of guselkumab, risankizumab, and tildrakizumab in these patient settings [ 60 , 63 , 64 ]. In any case, the current guidelines provide the same recommendations as for the other biological classes [ 42 ].…”