炎症性肠病患者英夫利昔单抗皮下和静脉给药的现实世界比较。

IF 3.9 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2025-06-23 DOI:10.5217/ir.2025.00001

Kwang Woo Kim, Hyoun Woo Kang, Seong-Joon Koh, Hyuk Yoon, Sihyun Kim, Yukyung Jun, Hyun Jung Lee, Jong Pil Im, Young Soo Park, Ji Won Kim, Joo Sung Kim

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引用次数: 0

摘要

背景/目的：我们比较了静脉注射和皮下注射英夫利昔单抗（IFX）治疗炎症性肠病（IBD）。方法：这项回顾性、多中心、观察性研究纳入了静脉或皮下IFX治疗的患者。在基线、6个月和12个月开始使用任何一种IFX治疗后比较序列参数。主要结果是治疗12个月后IFX谷底水平的比较。结果：本研究共纳入183名受试者。6个月后，皮下注射组与静脉注射组比较差异有统计学意义；临床疾病活动性（0%比15%，P= 0.007）和IFX谷水平（21.72±8.71 μg/mL比7.70±16.65 μg/mL， P= 0.002）。12个月后，与静脉注射相比，皮下注射改善了临床疾病活动性（0%比15%，P= 0.044）和IFX谷水平（20.41±12.91 μg/mL比7.06±6.81 μg/mL， P< 0.001）。与基线数据相比，分析各组的连续变化，我们观察到皮下；6个月粪钙保护蛋白（676.3±976.6 μg/g vs. 253.9±483.9 μg/g， P= 0.014）、6个月IFX谷水平（7.00±5.67 μg/mL vs. 18.44±6.34 μg/mL， P= 0.026）、12个月IFX谷水平（7.00±5.67 μg/mL vs. 21.33±4.50 μg/mL， P= 0.034）。结论：本研究表明皮下IFX作为IBD的替代治疗方案的潜在适用性。

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A real-world comparison of subcutaneous to intravenous administration of infliximab in patients with inflammatory bowel disease.

Background/aims: We compared intravenous and subcutaneous infliximab (IFX) as treatment for inflammatory bowel disease (IBD).

Methods: This retrospective, multicenter, observational study enrolled patients treated with either intravenous or subcutaneous IFX. Sequential parameters were compared at baseline, 6 months, and 12 months following the initiation of treatment with either type of IFX. The primary outcome was the comparison of the IFX trough levels after 12 months of treatment.

Results: In total, 183 participants were included in this study. After 6 months, the subcutaneous group exhibited significant differences compared to the intravenous group; in terms of clinical disease activity (0% vs. 15%, P= 0.007) and IFX trough level (21.72 ± 8.71 μg/mL vs. 7.70 ± 16.65 μg/mL, P= 0.002). After 12 months, subcutaneous, as compared to intravenous, achieved improved clinical disease activity (0% vs. 15%, P= 0.044) and IFX trough level (20.41 ± 12.91 μg/mL vs. 7.06 ± 6.81 μg/mL, P< 0.001). Analyzing the sequential changes compared with baseline data within each group, we observed significant alterations in subcutaneous; 6 months fecal calprotectin (676.3 ± 976.6 μg/g vs. 253.9 ± 483.9 μg/g, P= 0.014), 6 months IFX trough level (7.00 ± 5.67 μg/mL vs. 18.44 ± 6.34 μg/mL, P= 0.026), and 12 months IFX trough level (7.00 ± 5.67 μg/mL vs. 21.33 ± 4.50 μg/mL, P= 0.034).

Conclusions: This study indicates the potential suitability of subcutaneous IFX as an alternative treatment option for IBD.

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来源期刊

Intestinal Research GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

7.40

自引率

10.20%

发文量

审稿时长

38 weeks

期刊介绍： Intestinal Research (Intest Res) is the joint official publication of the Asian Organization for Crohn''s and Colitis (AOCC), Chinese Society of IBD (CSIBD), Japanese Society for IBD (JSIBD), Korean Association for the Study of Intestinal Diseases (KASID), Taiwan Society of IBD (TSIBD) and Colitis Crohn''s Foundation (India) (CCF, india). The aim of the Journal is to provide broad and in-depth analysis of intestinal diseases, especially inflammatory bowel disease, which shows increasing tendency and significance. As a Journal specialized in clinical and translational research in gastroenterology, it encompasses multiple aspects of diseases originated from the small and large intestines. The Journal also seeks to propagate and exchange useful innovations, both in ideas and in practice, within the research community. As a mode of scholarly communication, it encourages scientific investigation through the rigorous peer-review system and constitutes a qualified and continual platform for sharing studies of researchers and practitioners. Specifically, the Journal presents up-to-date coverage of medical researches on the physiology, epidemiology, pathophysiology, clinical presentations, and therapeutic interventions of the intestinal diseases. General topics of interest include inflammatory bowel disease, colon and small intestine cancer or polyp, endoscopy, irritable bowel syndrome and other motility disorders, infectious enterocolitis, intestinal tuberculosis, and so forth. The Journal publishes diverse types of academic materials such as editorials, clinical and basic reviews, original articles, case reports, letters to the editor, brief communications, perspective, statement or commentary, and images that are useful to clinicians and researchers.