The safety profile of ustekinumab in the treatment of patients with psoriasis and concurrent hepatitis B or C

Abstract

Antiviral prophylaxis appears to minimize the risk of viral reactivation in patients with concurrent psoriasis and HBV infection. Without effective anti-viral prophylaxis, the risk/benefit of ustekinumab treatment should be carefully assessed in patients with psoriasis and HBV or HCV infection and/or HCC. Close monitoring for HBV and HCV viral load is recommended, particularly for patients with high-risk factors. Serum aminotransferase determination may not be useful for early detection of viral reactivation.

Safety Profile of Secukinumab in Treatment of Patients with Psoriasis and Concurrent Hepatitis B or C: A Multicentric Prospective Cohort Study

“…A more recent review by Snast et al (17) included 40 patients with psoriasis with chronic HBV infection and found that virus reactivation was documented in 8 (20%) patients on biologic therapy. Our previous study showed that 2 of 7 (29%) patients, not receiving antiviral prophylaxis, exhibited HBV reactivation during treatment with IL-12/23 p40 monoclonal antibody ustekinumab (6). In the present study, the HBV reactivation rate in patients with psoriasis who were positive for HBsAg and did not receive antiviral prophylaxis was 24%, which was lower than that observed in previous studies.…”

“…Hsien-Yi CHIU [1][2][3][4] , Rosaline Chung-yee HUI [5][6][7] , Yu-Huei HUANG [5][6][7] , Ruey-Yun HUANG …”

“…Outcome HBV virological reactivation was defined as a 10-fold increase in the HBV-DNA load, compared with the baseline value or a switch from the "undetectable" to the "detectable" status, and/or hepatitis B e antigen (HBeAg) seroconversion from negative to positive after secukinumab therapy (6,16,17). Hepatitis was defined as a ≥ 3-fold increase in ALT level that exceeded the upper limit of the normal value or an absolute increase in ALT level to > 100 IU/l (18).…”

“…Moreover, biologic agents alter the competence of the host immune-surveillance system to combat hepatitis virus infections, which may increase virus reactivation and replication, resulting in injury to the liver (3,4). Recent years have witnessed an increase in the number of cases of reactivation of hepatitis B (HBV) or hepatitis C (HCV) virus in patients with psoriasis who are receiving biologics (3,5,6).…”

The use of ustekinumab in patients with psoriasis and coexisting renal or hepatic dysfunction – a report of two cases

“…Moreover, they met the inclusion criteria [Psoriasis Area Severity Index (PASI) > 18, BSA > 10 with substantial quality of life impairment -DLQ ≥ 10]. Despite a high safety profile well documented in the literature, the application of the biological drug should be preceded by numerous laboratory tests that are intended to exclude foci of infection [1,2].…”