Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Dig Dis Sci. 2021 Sep;66(9):3124-3131. doi: 10.1007/s10620-020-06600-z. Epub 2020 Sep 13.
Although combining thiopurine with infliximab (IFX) is considered to improve the clinical efficacy of IFX when treating Crohn's disease (CD), it also increases the risk of adverse events (AEs). We compared the efficacy and safety of delayed thiopurine addition after loss of response (LOR) to IFX with the efficacy and safety of an earlier combination of thiopurine and IFX.
This retrospective study analyzed patients with CD who started IFX as a first-line biologic at Kyushu University Hospital between June 2002 and July 2018. Patients were assigned to either the early-combination (EC) group, who started IFX and thiopurine simultaneously, or the late-combination (LC) group, who were treated with IFX alone until they developed LOR. We compared the cumulative IFX continuation rates and AE incidence between the two groups.
One hundred seventy-six patients were enrolled in this study; 49 were enrolled in the EC group, and 127 were enrolled in the LC group. Disease activity at baseline did not significantly differ between the groups, nor did the cumulative IFX continuation rates differ between the groups (P = 0.30); however, the AE rate was significantly higher in the EC group than in the LC group (38.7% vs. 21.2%; P = 0.02). The severe AE rate was also higher in the EC group than in the LC group (18.3% vs 3.1%; P = 0.001).
Considering the risk-benefit balance, delayed addition of thiopurine after LOR to IFX might be an alternative strategy when using IFX to treat CD.
虽然在治疗克罗恩病(CD)时将硫唑嘌呤与英夫利昔单抗(IFX)联合使用被认为可以提高 IFX 的临床疗效,但也会增加不良事件(AE)的风险。我们比较了 IFX 治疗失应答(LOR)后延迟添加硫唑嘌呤与 IFX 与硫唑嘌呤早期联合的疗效和安全性。
本回顾性研究分析了 2002 年 6 月至 2018 年 7 月在九州大学医院接受 IFX 作为一线生物制剂治疗的 CD 患者。患者被分为早期联合(EC)组,即同时开始使用 IFX 和硫唑嘌呤,或晚期联合(LC)组,即单独使用 IFX 治疗直至发生 LOR。我们比较了两组之间的 IFX 持续使用累积率和 AE 发生率。
本研究共纳入 176 例患者;49 例纳入 EC 组,127 例纳入 LC 组。两组患者的基线疾病活动度无显著差异,IFX 持续使用累积率也无显著差异(P=0.30);然而,EC 组的 AE 发生率显著高于 LC 组(38.7%比 21.2%;P=0.02)。EC 组的严重 AE 发生率也高于 LC 组(18.3%比 3.1%;P=0.001)。
考虑到风险效益平衡,在使用 IFX 治疗 CD 时,LOR 后延迟添加硫唑嘌呤可能是一种替代策略。