CLINICAL REPORT
829 ActaDV ActaDV Advances in dermatology and venereology Acta Dermato-Venereologica
Safety Profile of Secukinumab in Treatment of Patients with Psoriasis and Concurrent Hepatitis B or C : A Multicentric Prospective Cohort Study
Hsien-Yi CHIU 1 – 4 , Rosaline Chung-yee HUI 5 – 7 , Yu-Huei HUANG 5 – 7 , Ruey-Yun HUANG 1 , Kai-Lung CHEN 1 , 3 , 4 , Ya-Chu TSAI 8 , Po-Ju LAI 9 , 10 , Ting-Shun WANG 3 , 4 , 9 , 10 and Tsen-Fang TSAI 3 , 4 Departments of Dermatology : 1 National Taiwan University Hospital Hsin-Chu Branch , Hsinchu , 3 National Taiwan University Hospital , 4 College of Medicine , National Taiwan University , Taipei , 5 Chang Gung Memorial Hospital , Linkou Branch , Taoyuan , 7 Drug Hypersensitivity Clinical and Research Center , Chang Gung Memorial Hospital , Linkou , 8 Far Eastern Memorial Hospital , New Taipei , 9 Chung Shan Medical University Hospital , Taichung , Taiwan and 10 Chung Shan Medical University , Taichung , 2 Institute of Biomedical Engineering , College of Medicine and College of Engineering , National Taiwan University , and 6 School of Medicine , College of Medicine , Chang Gung University , Taoyuan , Taiwan
Safety data for secukinumab in patients with psoriasis and viral hepatitis are lacking . The aim of this study is to investigate the risk of reactivation of hepatitis B virus ( HBV )/ hepatitis C virus ( HCV ) in patients with psoriasis who are receiving secukinumab therapy . This multicentre study screened 284 patients with psoriasis with available HBV and HCV serological data and 63 patients with concurrent HBV / HCV infection were enrolled . In the absence of antiviral prophylaxis , 7 of 46 ( 15.2 %) patients with HBV exhibited HBV reactivation during secukinumab therapy . The risk of reactivation was significantly higher in HBsAg-positive patients , compared with HBsAg-negative / HBcAb-positive patients ( 24.0 % vs . 4.17 %, p = 0.047 ). One of 14 ( 7.1 %) HCV patients showed enhanced replication of HCV with hepatitis . No virus reactivation occurred in patients receiving antiviral prophylaxis . HBsAg-positive and HBsAg-negative / HBcAb-positive psoriasis patients can develop virus reactivation during secukinumab therapy , thus necessitating close monitoring of viral load and considering an antiviral prophylaxis for all HBsAg-positive patients with psoriasis .
Key words : psoriasis ; secukinumab ; hepatitis B ; hepatitis C ; interleukin-17A inhibitor ; biologics .
Accepted Jun 5 , 2018 ; Epub ahead of print Jun 8 , 2018 Acta Derm Venereol 2018 ; 98 : 829 – 834 .
Corr : Tsen-Fang Tsai , Department of Dermatology , National Taiwan University Hospital , No . 7 Chung San South Road , Taipei , Taiwan . E-mail : tftsai @ yahoo . com
In the past decade , the emergence of biologic therapies , including anti-tumour necrosis factor ( anti-TNF-α ), anti-interleukin ( anti-IL ) 12 / 23 p40 monoclonal antibody , and the recently approved anti-IL-17 / IL-17R antibody , has substantially improved the treatment outcome of patients with psoriasis ( 1 ). However , safety concerns over the use of biologics still exist , especially in view of opportunistic infections , such as those caused by mycobacterial , bacterial , viral and fungal agents ( 2 ). 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
SIGNIFICANCE
This study showed that biologic agents alter the competence of the host immune-surveillance system to combat hepatitis virus infections and hepatitis B virus ( HBV ) or hepatitis C virus ( HCV ). Reactivation can occur in patients with psoriasis with concurrent HBV or HCV treated with secukinumab , an anti-interleukin 17 agent . The risk of virus reactivation varied in patients with psoriasis with different virological profiles . It is advisable to monitor the viral load / serum transaminase level and consider antiviral prophylaxis for all hepatitis B surface antigen-positive patients with psoriasis who are being treated with secukinumab .
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 ).
Secukinumab , a monoclonal antibody that selectively binds and neutralizes IL-17A , has demonstrated high efficacy in treating moderate-to-severe plaque psoriasis ( 7 ). However , IL-17 , a major effector cytokine of T-helper 17 ( Th17 ), has been shown to mediate host defence mechanisms in response to various infective agents ( 8 ). Emerging research has also shown that Th17 response is involved in various viral infections ( 9 – 11 ). Studies suggest that IL-17 plays a role in eliciting innate defence at mucosal sites and inducing infection-associated immunopathology during viral infections ( 12 ). Moreover , Th17 response is involved in the pathogenesis of viral hepatitis . The number of intrahepatic IL-17 and circulating IL-17-producing peripheral blood mononuclear cells was found to be significantly increased in patients with HBV and HCV infection ( 4 ). Available data also suggest that IL-17 plays an important role in suppressing HBV activity ( 4 ), and that Th17 cells drive the immune-mediated pathology of HBV and HCV ( 4 ). However , safety data for secukinumab in patients with psoriasis and viral hepatitis are lacking because these patients are always excluded from pivotal trials . Therefore , we conducted a multicentre study to assess the risk of virus reactivation in patients with psoriasis with concurrent HBV or HCV infection during secukinumab therapy and the usefulness of antiviral prophylaxis in real-life practice .
This is an open access article under the CC BY-NC license . www . medicaljournals . se / acta Journal Compilation © 2018 Acta Dermato-Venereologica . doi : 10.2340 / 00015555-2989 Acta Derm Venereol 2018 ; 98 : 829 – 834