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静脉注射乌司奴单抗强化治疗难治性克罗恩病

Intensification with Intravenous Ustekinumab in Refractory Crohn's Disease.

作者信息

Suárez Ferrer Cristina, Arroyo Argüelles José, Rueda García Jose Luis, García Ramírez Laura, Martin Arranz Eduardo, Sánchez Azofra María, Poza Cordón Joaquín, Noci Belda Jesús, Martin-Arranz Maria Dolores

机构信息

Inflammatory Bowel Disease Unit, Digestive Medicine Service, Hospital Universitario La Paz, 28046 Madrid, Spain.

IdiPAZ Study Group for Immune-Mediated Gastrointestinal Diseases, 28049 Madrid, Spain.

出版信息

J Clin Med. 2024 Jan 24;13(3):669. doi: 10.3390/jcm13030669.

DOI:10.3390/jcm13030669
PMID:38337361
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10856525/
Abstract

BACKGROUND

The rates of clinical and biochemical responses in Crohn's disease (CD) patients treated with intravenous (IV) ustekinumab (UST) intensification are scarcely described.

METHODS

Patients with diagnosis of CD who were under intensified IV ustekinumab treatment (130 mg every 4 weeks) were retrospectively included, evaluating the clinical and biochemical response 12 weeks after the change in treatment regimen (switch from SC to IV), as well as the serum levels of the drug.

RESULTS

Twenty-seven patients, all of whom had transitioned to intensified intravenous ustekinumab treatment due to a secondary loss of response to the drug, were included in the retrospective analysis. At the baseline visit, prior to changing IV UST, differences in levels were observed between intensified and non-intensified patients (7216 vs. 2842 ng/mL, = 0.00005). However, no significant differences were found between these two groups 12 weeks after IV intensification (7949 vs. 7937 ng/mL; = 0.99). In patients with previous intensified UST SC, a decrease in fecal calprotectin was observed 12 weeks after starting IV intensification, going from a mean of 1463 ug/g to 751 ug/g, although the differences were not significant ( = 0.14).

CONCLUSION

In our experience, intensifying treatment with IV UST leads to clinical and biochemical improvements in CD patients with a secondary loss of response to SC maintenance with this drug, and an increase in drug levels was observed 12 weeks after IV UST intensification.

摘要

背景

关于接受静脉注射(IV)优特克单抗(UST)强化治疗的克罗恩病(CD)患者的临床和生化反应率鲜有描述。

方法

回顾性纳入诊断为CD且正在接受强化IV优特克单抗治疗(每4周130mg)的患者,评估治疗方案改变(从皮下注射(SC)改为IV)12周后的临床和生化反应以及药物的血清水平。

结果

27例患者纳入回顾性分析,所有患者均因对该药物继发反应丧失而转为强化IV优特克单抗治疗。在基线访视时,即在改变IV UST之前,强化组和非强化组患者的水平存在差异(7216 vs. 2842 ng/mL,P = 0.00005)。然而,IV强化治疗12周后,这两组之间未发现显著差异(7949 vs. 7937 ng/mL;P = 0.99)。在先前接受强化UST SC治疗的患者中,开始IV强化治疗12周后,粪便钙卫蛋白有所下降,从平均1463μg/g降至751μg/g,尽管差异不显著(P = 0.14)。

结论

根据我们的经验,用IV UST强化治疗可使对该药物SC维持治疗继发反应丧失的CD患者在临床和生化方面得到改善,且IV UST强化治疗12周后观察到药物水平升高。

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本文引用的文献

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Inflamm Bowel Dis. 2023 Jul 5;29(7):1038-1046. doi: 10.1093/ibd/izac169.
2
Ustekinumab trough levels predicting laboratory and endoscopic remission in patients with Crohn's disease.乌司奴单抗浓度预测克罗恩病患者的实验室和内镜缓解。
BMC Gastroenterol. 2022 Apr 21;22(1):195. doi: 10.1186/s12876-022-02271-4.
3
Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial.
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Lancet Gastroenterol Hepatol. 2022 Apr;7(4):294-306. doi: 10.1016/S2468-1253(21)00474-X. Epub 2022 Feb 1.
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Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives.炎症性肠病生物制剂的治疗药物监测:未满足的需求和未来展望。
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Efficacy of ustekinumab in the treatment of patients with Crohn's disease with failure to previous conventional or biologic therapy: a prospective observational real-life study.乌司奴单抗治疗先前常规或生物治疗失败的克罗恩病患者的疗效:一项前瞻性观察性真实世界研究。
J Physiol Pharmacol. 2021 Aug;72(4). doi: 10.26402/jpp.2021.4.05. Epub 2021 Dec 31.
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Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis.比较生物疗法治疗中重度克罗恩病的疗效和安全性:系统评价和网络荟萃分析。
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Clin Gastroenterol Hepatol. 2021 Jan;19(1):104-110. doi: 10.1016/j.cgh.2020.02.035. Epub 2020 Feb 26.