Alejandro Mínguez, Elena Coello, Alejandro Garrido, Paula Ripoll, María Gomez, Mariam Aguas, Marisa Iborra, Elena Cerrillo, Lluis Tortosa, Virginia Bayarri, Noemí Bueno, Maria José Fernández, Remedios Marqués, Pilar Nos, Guillermo Bastida
{"title":"优化高度生物暴露的 IBD 患者静脉滴注 UST 的疗效。真实世界中的疗效和调整方案。","authors":"Alejandro Mínguez, Elena Coello, Alejandro Garrido, Paula Ripoll, María Gomez, Mariam Aguas, Marisa Iborra, Elena Cerrillo, Lluis Tortosa, Virginia Bayarri, Noemí Bueno, Maria José Fernández, Remedios Marqués, Pilar Nos, Guillermo Bastida","doi":"10.1016/j.gastrohep.2024.502253","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aims: </strong>Ustekinumab is an effective treatment for inflammatory bowel diseases. However, some patients do not respond to conventional doses. The aim of the study was to evaluate the effectiveness of intravenous maintenance ustekinumab in patients with secondary failure.</p><p><strong>Methods: </strong>Single-center, retrospective study in adult patients with intravenous maintenance ustekinumab. The reduction of biochemical activity markers, ustekinumab trough levels and clinical indices of activity were evaluated. Biological remission was defined as the percentage decrease fecal calprotectin ≥80% and/or final fecal calprotectin ≤250 and C reactive protein <5mg/L.</p><p><strong>Results: </strong>Thirty-one patients were included: Crohn's disease 77.4%. All included patients were bio-exposed and 61.3% had carried ≥2 biologics. Pre-intravenous maintenance mean Harvey-Bradshaw Index was 6.5±4.38 vs 5±3.1 at week 8 (p=0.024) vs 4.1±3.1 at week 24 (p=0.019). The median ustekinumab trough level pre-intravenous maintenance was 1.40μg/ml [IQR 2.3] vs 5.35μg/ml [IQR 4.1] at week 8 (p<0.001) vs 4.8μg/ml [IQR 3.9] at week 24 (p<0.001). The pre-intravenous maintenance median fecal calprotectin was 809μg/g [IQR: 2256] vs 423μg/g [IQR: 999] at week 8 (p=0.025) vs 333μg/g [508] (p=0.001) at week 24. At the end of follow-up 48% went into biological remission. The presence of perianal disease was associated with lower biological remission (70.6% vs 27.3%, p=0.025). Median intravenous ustekinumab maintenance time was 8.55 [IQR 23.9] months. In 83.9% of patients no serious infections or malignancy were documented.</p><p><strong>Conclusions: </strong>The use of maintenance intravenous ustekinumab appears to be an effective and safe strategy that can be evaluated as a salvage treatment especially in highly bio-exposed patients.</p>","PeriodicalId":12802,"journal":{"name":"Gastroenterologia y hepatologia","volume":" ","pages":"502253"},"PeriodicalIF":2.2000,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Optimizing outcomes with maintenance IV UST in highly bio-exposed patients with IBD. 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引用次数: 0
摘要
背景和目的优昔单抗是治疗炎症性肠病的有效药物。然而,一些患者对常规剂量无效。本研究旨在评估静脉维持乌司替库单抗治疗继发性失败患者的有效性:单中心回顾性研究:成年患者静脉注射乌司替库单抗。评估生化活性指标、乌斯特库单抗谷值水平和临床活性指标的降低情况。生物缓解定义为粪便钙蛋白下降百分比≥80%和/或最终粪便钙蛋白≤250和C反应蛋白<5mg/L:共纳入31例患者:克罗恩病占77.4%。所有纳入的患者均有生物暴露,61.3%的患者携带≥2种生物制剂。静脉维持治疗前的平均哈维-布拉肖指数(Harvey-Bradshaw Index)为(6.5±4.38),第8周为(5±3.1)(P=0.024),第24周为(4.1±3.1)(P=0.019)。静脉维持治疗前的乌司替库单抗谷值中位数为1.40µg/ml [IQR 2.3] vs 第8周时为5.35µg/ml [IQR 4.1] (p结论:静脉注射乌斯特库单抗似乎是一种有效而安全的治疗策略,可作为一种挽救性治疗方法进行评估,尤其是对于生物暴露程度较高的患者。
Optimizing outcomes with maintenance IV UST in highly bio-exposed patients with IBD. Efficacy and adjusted regimen in real world.
Background and aims: Ustekinumab is an effective treatment for inflammatory bowel diseases. However, some patients do not respond to conventional doses. The aim of the study was to evaluate the effectiveness of intravenous maintenance ustekinumab in patients with secondary failure.
Methods: Single-center, retrospective study in adult patients with intravenous maintenance ustekinumab. The reduction of biochemical activity markers, ustekinumab trough levels and clinical indices of activity were evaluated. Biological remission was defined as the percentage decrease fecal calprotectin ≥80% and/or final fecal calprotectin ≤250 and C reactive protein <5mg/L.
Results: Thirty-one patients were included: Crohn's disease 77.4%. All included patients were bio-exposed and 61.3% had carried ≥2 biologics. Pre-intravenous maintenance mean Harvey-Bradshaw Index was 6.5±4.38 vs 5±3.1 at week 8 (p=0.024) vs 4.1±3.1 at week 24 (p=0.019). The median ustekinumab trough level pre-intravenous maintenance was 1.40μg/ml [IQR 2.3] vs 5.35μg/ml [IQR 4.1] at week 8 (p<0.001) vs 4.8μg/ml [IQR 3.9] at week 24 (p<0.001). The pre-intravenous maintenance median fecal calprotectin was 809μg/g [IQR: 2256] vs 423μg/g [IQR: 999] at week 8 (p=0.025) vs 333μg/g [508] (p=0.001) at week 24. At the end of follow-up 48% went into biological remission. The presence of perianal disease was associated with lower biological remission (70.6% vs 27.3%, p=0.025). Median intravenous ustekinumab maintenance time was 8.55 [IQR 23.9] months. In 83.9% of patients no serious infections or malignancy were documented.
Conclusions: The use of maintenance intravenous ustekinumab appears to be an effective and safe strategy that can be evaluated as a salvage treatment especially in highly bio-exposed patients.
期刊介绍:
Gastroenterology and Hepatology is the first journal to cover the latest advances in pathology of the gastrointestinal tract, liver, pancreas, and bile ducts, making it an indispensable tool for gastroenterologists, hepatologists, internists and general practitioners.