Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Center of Inflammatory Bowel Disease, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Inflamm Bowel Dis. 2024 Jan 5;30(1):45-52. doi: 10.1093/ibd/izad032.
Ustekinumab (UST) was approved in China for moderate-to-severe Crohn's disease (CD) in 2020. The prevalence rates of tuberculosis and hepatitis B virus (HBV) infection are high in China, and no guideline clearly states that tuberculosis chemoprophylaxis or prophylactic anti-HBV therapy should be prescribed before UST administration. This study aimed to assess the risk of tuberculosis and HBV reactivation in CD patients with latent tuberculosis infection (LTBI) and previous HBV infection receiving UST.
A multicenter retrospective cohort study was carried out at 68 hospitals in China to assess 721 adult CD cases administered UST between May 1, 2020, and December 31, 2021. CD and concurrent LTBI or HBV carrier were included. Hepatitis B serology, T-SPOT.TB, and tuberculin skin tests were performed at baseline. The primary outcome was tuberculosis or HBV reactivation.
Patients with CD-concomitant LTBI or who were HBV carriers receiving UST therapy were retrospectively enrolled from 15 hospitals in China. A total of 53 CD with LTBI patients and 17 CD with HBV carrier patients receiving UST were included. Treatment and follow-up durations were 50 ± 20 weeks and 50 ± 15 weeks in the LTBI and HBV carrier groups, respectively. A total of 25 CD patients with LTBI underwent chemoprophylaxis and 28 did not. A total of 11 HBV carriers had antiviral prophylaxis and 6 did not. No patient experienced tuberculosis or HBV reactivation or liver dysfunction during follow-up.
UST was safe for treatment of CD because no patient developed tuberculosis, persistent hepatitis, or acute liver failure during therapy, whether with a prophylactic regimen or not, based on our sample size and limited follow-up time.
乌司奴单抗（UST）于 2020 年在中国获批用于中重度克罗恩病（CD）。中国结核分枝杆菌和乙型肝炎病毒（HBV）感染的患病率较高，尚无指南明确规定在使用 UST 之前应进行结核分枝杆菌化学预防或预防性抗 HBV 治疗。本研究旨在评估接受 UST 治疗的潜伏性结核感染（LTBI）和既往 HBV 感染的 CD 患者中结核和 HBV 再激活的风险。
在中国 68 家医院进行了一项多中心回顾性队列研究，评估了 2020 年 5 月 1 日至 2021 年 12 月 31 日期间接受 UST 治疗的 721 例成年 CD 病例。纳入 CD 合并 LTBI 或 HBV 携带者。基线时进行乙肝血清学、T-SPOT.TB 和结核菌素皮肤试验。主要结局是结核或 HBV 再激活。
从中国的 15 家医院回顾性纳入 CD 合并 LTBI 或 HBV 携带者接受 UST 治疗的患者。共纳入 53 例 CD 合并 LTBI 患者和 17 例 CD 合并 HBV 携带者接受 UST 治疗。LTBI 和 HBV 携带者组的治疗和随访时间分别为 50±20 周和 50±15 周。25 例 CD 合并 LTBI 患者接受了化学预防，28 例未接受。11 例 HBV 携带者接受了抗病毒预防，6 例未接受。随访期间无患者发生结核、持续性肝炎或急性肝功能衰竭。
根据我们的样本量和有限的随访时间，UST 治疗 CD 是安全的，因为无论是否采用预防方案，治疗期间均无患者发生结核、持续性肝炎或急性肝功能衰竭。
