Kankılıç Ayşegül Tel, Karakoyun Ömer, Ayhan Erhan
Department of Dermatology, Dicle University Faculty of Medicine, Diyarbakır, Turkey.
Cutan Ocul Toxicol. 2025 Mar;44(1):113-117. doi: 10.1080/15569527.2025.2475444. Epub 2025 Mar 8.
In recent years, the frequency of use of biological agents in the treatment of many dermatological diseases has been increasing. While effective, these treatments may carry the risk of hepatitis B virus (HBV) reactivation, particularly in patients with underlying or resolved HBV infection. Data on the risk of reactivation—especially with newer IL-23 antagonists that treat psoriasis vulgaris such as risankizumab and guselkumab, and IL-17 antagonists such as ixekizumab and secukinumab—remain limited. The aim of this study was to investigate HBV seroprevalence in patients with psoriasis using biological drug therapy and to investigate the frequency of reactivation and the importance of prophylactic treatment in this patient group at risk of HBV reactivation.
This retrospective study included 219 patients (aged 18-92) with psoriasis vulgaris who were treated with at least one biological drug treatment for at least 3 months at Dicle University Dermatology Clinic between 1 January 2018 and 30 June 2024. HBV serological markers (HBsAg, anti-HBcIgG, anti-HBs) and laboratory test results were evaluated. Patients were divided into five groups based on HBV serological: natural immune, chronic HBV infection, isolated anti-HBcIgG positivity, vaccinated and susceptible. These serological tests were repeated every 6 months during follow-up. Patients who did not meet the above-mentioned criteria or had incomplete test results were excluded from the study. Screening for hepatitis B reactivation was performed only in those with a positive anti-HBc IgG test who were at risk of reactivation. This was defined as either: Those who had a positive HBV DNA test prior to biological treatment and had an increase of >1 log10İU/mL in HBV DNA titre during biological treatment use; or those who initially tested negative for HBV DNA prior to starting biological treatment but became HBV DNA–positive during treatment were considered to have HBV reactivation.
Of the 219 psoriasis vulgaris patients, 102 (46.6%) females and 117 (53.4%) males. The distribution biological agents uses was as follows: 87 (39.7%) secucinumab, 29 (13.2%) ixekizumab, 47 (21.5%), guselkizumab, and 56 (25.6%) risankizumab. Patients were categorized into five (5) groups based on HBV serology and among these groups, 46 (21%) patients (10 with secucinumab and risakizumab, 12 with ixekizumab, and 14 with guselkizumab) were found to be at risk of hepatitis B reactivation (anti-HBc IgG test positive). It was observed that 40 (86.96%) of these 46 patients at risk of hepatitis B reactivation used prophylaxis, and no reactivation developed. No significant ALT or AST elevation was detected in all patients during their biological treatment
IL-23 antagonist such as rizankizumab and guzelkumab, as well as IL-17 antagonists like secukinumab and ixekizumab, have been reported to carry a risk of hepatitis B reactivation during their use in the treatment of psoriasis vulgaris. Although published data on reactivation of HBV with the use of these newer and increasingly used treatments, particularly IL-23 antagonists, remains limited, our findings support their safe use when appropriate screening and prophylactic measures are implemented. The findings in this study highlight the importance of the use of prophylaxis treatment as a key measure to prevent hepatitis B reactivation in at-risk patients. Additionlly, HBV screening should be performed prior to initiating biological therapy, with antiviral prophylaxis provided when necessary. Regular hepatitis screening every six months is also recommended to minimize potential complications, enable early detection and intervention, and ensure patient safety througout treatment.
近年来,生物制剂在多种皮肤病治疗中的使用频率不断增加。虽然这些治疗有效,但可能存在乙型肝炎病毒(HBV)重新激活的风险,尤其是在有潜在HBV感染或已治愈HBV感染的患者中。关于重新激活风险的数据,尤其是使用治疗寻常型银屑病的新型IL-23拮抗剂(如司库奇尤单抗和古塞库单抗)以及IL-17拮抗剂(如依奇珠单抗和苏金单抗)的数据仍然有限。本研究的目的是调查使用生物药物治疗的银屑病患者的HBV血清流行率,并调查该有HBV重新激活风险的患者群体中重新激活的频率以及预防性治疗的重要性。
这项回顾性研究纳入了219例年龄在18至92岁之间的寻常型银屑病患者,他们于2018年1月1日至2024年6月30日在迪克莱大学皮肤科诊所接受了至少一种生物药物治疗至少3个月。评估了HBV血清学标志物(HBsAg、抗-HBcIgG、抗-HBs)和实验室检查结果。根据HBV血清学将患者分为五组:自然免疫组、慢性HBV感染组、孤立抗-HBcIgG阳性组、接种疫苗组和易感组。在随访期间每6个月重复进行这些血清学检查。不符合上述标准或检查结果不完整的患者被排除在研究之外。仅对有重新激活风险且抗-HBc IgG检测呈阳性的患者进行乙型肝炎重新激活筛查。这被定义为:在生物治疗前HBV DNA检测呈阳性且在生物治疗期间HBV DNA滴度增加>1 log10IU/mL的患者;或在开始生物治疗前HBV DNA初始检测为阴性但在治疗期间变为HBV DNA阳性的患者被认为发生了HBV重新激活。
在219例寻常型银屑病患者中,女性102例(46.6%),男性117例(53.4%)。生物制剂的使用分布如下:司库奇尤单抗87例(39.7%),依奇珠单抗29例(13.2%),古塞库单抗47例(21.5%),司库奇尤单抗56例(25.6%)。根据HBV血清学将患者分为五组,在这些组中,发现46例(21%)患者(司库奇尤单抗和司库奇尤单抗10例,依奇珠单抗12例,古塞库单抗14例)有乙型肝炎重新激活的风险(抗-HBc IgG检测呈阳性)。观察到这46例有乙型肝炎重新激活风险的患者中有40例(86.96%)使用了预防措施,且未发生重新激活。在所有患者的生物治疗期间未检测到显著的ALT或AST升高。
据报道,司库奇尤单抗和古塞库单抗等IL-23拮抗剂以及司库奇尤单抗和依奇珠单抗等IL-17拮抗剂在用于治疗寻常型银屑病时存在乙型肝炎重新激活的风险。尽管关于使用这些越来越常用的新型治疗方法,特别是IL-23拮抗剂导致HBV重新激活的已发表数据仍然有限,但我们的研究结果支持在实施适当的筛查和预防措施时安全使用它们。本研究结果强调了使用预防性治疗作为预防高危患者乙型肝炎重新激活的关键措施的重要性。此外,在开始生物治疗前应进行HBV筛查,必要时提供抗病毒预防。还建议每六个月定期进行肝炎筛查,以尽量减少潜在并发症