儿童IBD患者接受英夫利昔单抗和主动药物监测从早期伴随免疫调节治疗中获益:一项10年真实队列的回顾性分析

IF 4.5 3区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Hannes Hoelz, Lena Bragagna, Anna Litwin, Sibylle Koletzko, Thu Giang Le Thi, Tobias Schwerd
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引用次数: 0

摘要

背景:儿童炎症性肠病(pIBD)二线治疗的有限批准需要优化英夫利昔单抗(IFX)与主动治疗药物监测(TDM)的使用。我们研究了早期联合免疫调节剂(IMM)治疗是否能提供额外的益处。方法:回顾性回顾2013年至2022年期间所有接受IFX和主动TDM治疗的儿童的医疗记录,在3至60个月的随访中,对imearly (IFX开始后IMM≤3个月)与IMMother/no(晚/短或无IMM)进行评估。Kaplan-Meier分析用于分析IFX停药至反应丧失(LOR)的时间或IFX抗体(ATI)产生的时间。结果:回顾了315例pIBD患者;其中127例2855次就诊(77例CD, 50例UC/ ibd未分类)。60例患者接受imnearly治疗,20例患者接受IMMother治疗,47例患者接受IFX单药治疗。IMMearly和IMMother/no的中位随访时间分别为30个月和26个月,具有可比性的主动TDM。英夫利昔单抗治疗60个月后的持续性为68%。7例imnear患者和15例IMMother/no患者出现反应丧失(P = 0.16)。早期联合治疗可显著延迟肺活度与IFX停药(中位肺活度无间隔为近30个月vs IMMother/no 9个月,P = 0.01)。IMMother/no患者分别在1年、3年和5年后停用IFX时发生LOR的可能性增加10倍、3倍和2倍。在ATI阳性(>10任意单位/毫升[AU/mL])或高(>100 AU/mL)、ATI中位数浓度和ATI无间隔方面,组间无显著差异。结论:与晚期/短期或无IMM治疗相比,主动监测的pIBD患者早期IMM联合治疗显着延长了中位LOR空闲时间。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pediatric IBD Patients Treated With Infliximab and Proactive Drug Monitoring Benefit From Early Concomitant Immunomodulatory Therapy: A Retrospective Analysis of a 10-Year Real-Life Cohort.

Background: Limited approval of second-line treatments in pediatric inflammatory bowel disease (pIBD) necessitates optimized use of infliximab (IFX) with proactive therapeutic drug monitoring (TDM). We investigated whether early combo-therapy with an immunomodulator (IMM) provides additional benefit.

Methods: In the retrospectively reviewed medical records of all children treated with IFX and proactive TDM between 2013 and 2022, IMMearly (IMM ≤3 months since IFX start) was evaluated against IMMother/no (late/short or no IMM) over follow-up of 3 to 60 months. Kaplan-Meier analysis was used to analyze time to loss of response (LOR) with IFX discontinuation or time to antibodies-to-IFX (ATI) development.

Results: Three hundred fifteen patients with pIBD were reviewed; of those, 127 with 2855 visits were included (77 CD, 50 UC/IBD-unclassified). Sixty patients received IMMearly, 20 patients IMMother, and 47 had IFX monotherapy. Median follow-up time was 30 and 26 months for IMMearly and IMMother/no, respectively, with comparable proactive TDM. Infliximab treatment persistence was 68% after 60 months. Loss of response was observed in 7 IMMearly and 15 IMMother/no patients (P = .16). Early combo-therapy significantly delayed LOR with IFX discontinuation (median LOR free interval IMMearly 30 months vs IMMother/no 9 months, P = .01). Patients with IMMother/no were 10-, 3- and 2-times more likely to experience LOR with IFX discontinuation after 1, 3, and 5 years, respectively. There were no significant group differences regarding the presence of any positive (>10 arbitrary units per milliliter [AU/mL]) or high (>100 AU/mL) ATI, median ATI concentrations, and ATI-free interval.

Conclusions: Early IMM combo-therapy in proactively monitored patients with pIBD significantly prolonged the median LOR free interval compared with late/short or no IMM treatment.

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来源期刊
Inflammatory Bowel Diseases
Inflammatory Bowel Diseases 医学-胃肠肝病学
CiteScore
9.70
自引率
6.10%
发文量
462
审稿时长
1 months
期刊介绍: Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.
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