Shantou University Medical College, Shantou, China.
Department of Rheumatology and Immunology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Clin Rheumatol. 2023 Sep;42(9):2369-2376. doi: 10.1007/s10067-023-06630-8. Epub 2023 May 23.
To evaluate the safety of secukinumab (SEC) in the treatment of patients with axial spondyloarthritis (axSpA) and concurrent hepatitis B virus (HBV) infection or latent tuberculosis infection (LTBI).
This is a retrospective cohort study. Adult axSpA patients with HBV infection or LTBI receiving SEC treatment for at least 3 months from March 2020 to July 2022 in Guangdong Provincial People's Hospital were included. Patients were screened for HBV infection and LTBI before SEC treatment. During follow-up, reactivation of HBV infection and LTBI was monitored. Relevant data were collected and analyzed.
A total of 43 axSpA patients with HBV infection or LTBI were included, of whom 37 were with HBV infection, 6 were with LTBI. Six out of thirty-seven (16.2%) patients with axSpA and concurrent HBV infection exhibited HBV reactivation after 9.0 ± 5.7 months of SEC treatment. Among them, 3 patients had chronic HBV infection and received anti-HBV prophylaxis, 2 patients had chronic HBV infection but did not receive anti-HBV prophylaxis, and 1 patient had occult HBV infection and did not receive antiviral prophylaxis. None of the 6 axSpA patients with LTBI developed reactivation of LTBI, whether received anti-TB prophylaxis or not.
HBV reactivation can occur in axSpA patients with different types of HBV infection undergoing SEC treatment, whether receive antiviral prophylaxis or not. Close monitoring of HBV reactivation in axSpA patients with HBV infection undergoing SEC treatment is mandatory. Anti-HBV prophylaxis may be beneficial. In contrast, SEC may be safe in axSpA patients with LTBI, even in patients not receiving anti-TB prophylaxis. Key Points •Currently, most evidence about the safety of SEC in patients with HBV infection and LTBI were from patients with psoriasis. Our study adds data about the safety of SEC in Chinese axSpA patients with concurrent HBV infection or LTBI in real-world clinical setting. •Our study showed that HBV reactivation can occur in axSpA patients with different types of HBV infection undergoing SEC treatment, whether receive antiviral prophylaxis or not. •Close monitoring of serum HBV markers, HBV DNA load, and liver function is mandatory in axSpA patients with chronic, occult, and resolved HBV infection undergoing SEC treatment. Anti-HBV prophylaxis may be beneficial in all HBsAg-positive patients and HBsAg-negative, HBcAb-positive patients at high risk of HBV reactivation who are receiving SEC therapy. •None of the axSpA patients with LTBI, whether received anti-TB prophylaxis or not, developed reactivation of LTBI in our study. SEC may be safe in axSpA patients with LTBI, even in patients not receiving anti-TB prophylaxis.
评估司库奇尤单抗(SEC)治疗合并乙型肝炎病毒(HBV)感染或潜伏性结核感染(LTBI)的中轴型脊柱关节炎(axSpA)患者的安全性。
这是一项回顾性队列研究。纳入 2020 年 3 月至 2022 年 7 月在广东省人民医院接受 SEC 治疗至少 3 个月的合并 HBV 感染或 LTBI 的 axSpA 成年患者。在 SEC 治疗前对患者进行 HBV 感染和 LTBI 筛查。在随访期间,监测 HBV 感染再激活和 LTBI。收集并分析相关数据。
共纳入 43 例合并 HBV 感染或 LTBI 的 axSpA 患者,其中 37 例为 HBV 感染者,6 例为 LTBI 者。37 例合并 HBV 感染的 axSpA 患者中,有 6 例(16.2%)在 SEC 治疗 9.0±5.7 个月后出现 HBV 再激活。其中,3 例慢性 HBV 感染者接受了抗 HBV 预防治疗,2 例慢性 HBV 感染者未接受抗 HBV 预防治疗,1 例隐匿性 HBV 感染者未接受抗病毒预防治疗。6 例 LTBI 患者均未出现 LTBI 再激活,无论是否接受抗结核预防治疗。
接受 SEC 治疗的不同类型 HBV 感染者的 axSpA 患者可能会发生 HBV 再激活,无论是否接受抗病毒预防治疗。对接受 SEC 治疗的合并 HBV 感染的 axSpA 患者进行 HBV 再激活的密切监测是必要的。抗 HBV 预防治疗可能有益。相比之下,SEC 在合并 LTBI 的 axSpA 患者中可能是安全的,即使在未接受抗结核预防治疗的患者中也是如此。关键点:目前,大多数关于 SEC 在 HBV 感染和 LTBI 患者中安全性的证据均来自银屑病患者。本研究在真实临床环境中增加了 SEC 在合并 HBV 感染或 LTBI 的中国 axSpA 患者中的安全性数据。我们的研究表明,在接受 SEC 治疗的不同类型 HBV 感染者的 axSpA 患者中,无论是否接受抗病毒预防治疗,均可能发生 HBV 再激活。在接受 SEC 治疗的慢性、隐匿性和已解决 HBV 感染的 axSpA 患者中,必须密切监测血清 HBV 标志物、HBV DNA 载量和肝功能。所有 HBsAg 阳性和高 HBV 再激活风险的 HBsAg 阴性、HBcAb 阳性患者接受 SEC 治疗时,抗 HBV 预防治疗可能有益。在本研究中,无论是否接受抗结核预防治疗,合并 LTBI 的 axSpA 患者均未发生 LTBI 再激活。SEC 在合并 LTBI 的 axSpA 患者中可能是安全的,即使在未接受抗结核预防治疗的患者中也是如此。