Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study
Infliximab and newly diagnosed neoplasia in Crohn's disease: a multicentre matched pair study
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DOI：
10.1136/gut.2005.075937
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发表时间：
2006-02-01
期刊：
影响因子：
24.5
通讯作者：
Pallone, F
中科院分区：
文献类型：
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作者：
Biancone, L;Orlando, A;Pallone, F
背景和目标：抗肿瘤坏死因子a抗体（英夫利昔单抗）在克罗恩病（CD）中的广泛使用引起了对长期可能的癌症风险的担忧。在配对研究中，我们评估是否英夫利西单抗与肿瘤风险增加相关。方法：在多中心配对研究中，404例CD患者接受英夫利西单抗（CD-IFX）与404例CD患者从未接受过英夫利西单抗（CD-C）相匹配。病例组和对照组在性别、年龄（+/- 5岁）、CD部位、诊断时年龄（+/- 5岁）、免疫抑制剂使用和随访方面相匹配。新诊断的肿瘤，从1999年4月至2004年10月recorded.Results：在404 CD-IFX，肿瘤被诊断为9例（2.22%），而在404 CD-C，7例患者发生肿瘤（1.73%）（比值比1.33（95%置信区间0.46 - 3.84），p = 0.40）。经患者年随访调整的生存曲线显示CD-IFX和CD-C之间无差异（p = 0. 90;对数秩检验）。在CD-IFX组中，有1例胆管癌、3例乳腺癌、1例皮肤癌、1例白血病、1例喉癌和2例肛门癌。在7/404例（1.73%）CD-C中，有3例肠腺癌（2例盲肠，1例直肠），1例基底细胞瘤，1例脊髓瘤，1例非霍奇金淋巴瘤和1例乳腺癌。两组之间诊断为肿瘤的年龄无差异（CD-IFX vs CD-C：中位数50（范围40 - 70岁）vs 45（27 - 72）; p = 0.50）。结论：在我们的多中心配对研究中，接受英夫利昔单抗治疗的CD患者新诊断为肿瘤的频率与从未接受过英夫利昔单抗治疗的CD患者相当。
Background and aims: The widespread use of anti-tumour necrosis factor a antibody (Infliximab) in Crohn's disease (CD) raises concerns about a possible cancer risk in the long term. In a matched pair study, we assessed whether Infliximab is associated with an increased risk of neoplasia.Methods: In a multicentre matched pair study, 404 CD patients treated with Infliximab (CD-IFX) were matched with 404 CD patients who had never received Infliximab (CD-C). Cases and controls were matched for sex, age (+/- 5 years), site of CD, age at diagnosis (+/- 5 years), immunosuppressant use, and follow up. New diagnoses of neoplasia from April 1999 to October 2004 were recorded.Results: Among the 404 CD-IFX, neoplasia was diagnosed in nine patients (2.22%) while among the 404 CD-C, seven patients developed neoplasia (1.73%) (odds ratio 1.33 (95% confidence interval 0.46 - 3.84); p = 0.40). The survival curve adjusted for patient year of follow up showed no differences between CD-IFX and CD-C (p = 0.90; log rank test). In the CD-IFX group, there was one cholangiocarcinoma, three breast cancers, one skin cancer, one leukaemia, one laryngeal cancer, and two anal carcinomas. Among the 7/404 (1.73%) CD-C, there were three intestinal adenocarcinomas (two caecum, one rectum), one basalioma, one spinalioma, one non-Hodgkin's lymphoma, and one breast cancer. Age at diagnosis of neoplasia did not differ between groups (CD-IFX v CD-C: median 50 (range 40 - 70 years) v 45 (27 - 72); p = 0.50).Conclusion: In our multicentre matched pair study, the frequency of a new diagnosis of neoplasia in CD patients treated with Infliximab was comparable with CD patients who had never received Infliximab.