Alhalabi Marouf M, Almokdad Rasha
Gastroenterology Department, Damascus Hospital, Damascus, Syria.
Eur J Gastroenterol Hepatol. 2025 Jan 1;37(1):1-9. doi: 10.1097/MEG.0000000000002863. Epub 2024 Nov 27.
This meta-analysis will evaluate the risk of hepatitis B reactivation in patients treated with ustekinumab for inflammatory bowel disease and psoriasis. We aim to determine the true incidence of this adverse event, reconcile discrepancies in reported reactivation rates, and elucidate the associated risk.
We conducted a rigorous systematic review adhering to established guidelines. Major databases like MEDLINE, Google Scholar, CENTRAL, and ClinicalTrials.gov were searched. Studies involving patients with documented hepatitis B infection undergoing ustekinumab therapy were included. Patients receiving concurrent antiviral medications were excluded. To account for potential underreporting, studies without reactivation events or with sample sizes ≥3 were also considered by using generalized linear mixed models and Clopper-Pearson confidence intervals. This review was prospectively registered in PROSPERO (CRD42023418130).
We analyzed data from nine studies involving 104 hepatitis B virus (HBV)-infected patients. The pooled HBV reactivation (HBVr) incidence among hepatitis B surface antigen-positive patients was 10% [95% confidence interval (CI): 0-31%], with low heterogeneity (I2 = 7.13%, τ2 = 0.4) and a nonsignificant Q-statistic (Q = 5.38, P = 0.37). For the occult HBV-infected patients, the pooled HBVr incidence was 3% (95% CI: 0-11%), with no heterogeneity (I2 = 0%, τ2 = 0.0) and a nonsignificant Q-statistic (Q = 2.7, P = 0.61). The reactivation rates showed high consistency across studies, with no significant difference between the two groups.
While our data suggest lower HBVr risk with ustekinumab, confirmation is needed due to limited sample size and retrospective design.
本荟萃分析将评估接受乌司奴单抗治疗的炎症性肠病和银屑病患者发生乙型肝炎再激活的风险。我们旨在确定这一不良事件的真实发生率，调和报告的再激活率差异，并阐明相关风险。
我们严格按照既定指南进行系统评价。检索了MEDLINE、谷歌学术、CENTRAL和ClinicalTrials.gov等主要数据库。纳入了涉及接受乌司奴单抗治疗的有记录的乙型肝炎感染患者的研究。排除同时接受抗病毒药物治疗的患者。为了考虑潜在的报告不足情况，还通过使用广义线性混合模型和克洛普 - 皮尔逊置信区间对无再激活事件或样本量≥3的研究进行了分析。本评价已在PROSPERO（CRD42023418130）中进行前瞻性注册。
我们分析了9项涉及104例乙型肝炎病毒（HBV）感染患者的研究数据。乙型肝炎表面抗原阳性患者中HBV再激活（HBVr）的合并发生率为10%[95%置信区间（CI）：0 - 31%]，异质性较低（I2 = 7.13%，τ2 = 0.4），Q统计量无显著性差异（Q = 5.38，P = 0.37）。对于隐匿性HBV感染患者，HBVr合并发生率为3%（95%CI：0 - 11%），无异质性（I2 = 0%，τ2 = 0.0），Q统计量无显著性差异（Q = 2.7，P = 0.61）。各研究的再激活率显示出高度一致性，两组之间无显著差异。
虽然我们的数据表明乌司奴单抗导致HBVr的风险较低，但由于样本量有限和回顾性设计，仍需要进一步证实。
