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英夫利昔单抗和阿达木单抗治疗炎症性肠病门诊患者的长期真实疗效和安全性。

Long-term real-life efficacy and safety of infliximab and adalimumab in the treatment of inflammatory bowel diseases outpatients.

机构信息

Territorial Gastroenterology Service, ASL BAT, Andria.

Division of Gastroenterology, 'Brotzu' Hospital, Cagliari.

出版信息

Eur J Gastroenterol Hepatol. 2021 May 1;33(5):670-679. doi: 10.1097/MEG.0000000000002087.

DOI:10.1097/MEG.0000000000002087
PMID:33741797
Abstract

BACKGROUND

Infliximab and adalimumab are widely used for the treatment of Crohn's disease and ulcerative colitis.

AIM

To compare the long-term efficacy and safety of infliximab and adalimumab in a large cohort of Crohn's disease and ulcerative colitis patients reflecting real-life clinical practice.

METHODS

Seven hundred twelve patients were retrospectively reviewed, 410 with Crohn's disease (268 treated with adalimumab and 142 with infliximab; median follow-up 60 months, range, 36-72) and 302 with ulcerative colitis (118 treated with adalimumab and 184 with infliximab; median follow-up 48 months, range, 36-84).

RESULTS

In Crohn's disease, clinical remission was maintained in 75.0% of adalimumab vs. in 72.5% of infliximab patients (P = 0.699); mucosal healing and steroid-free remission were maintained in 49.5% of adalimumab vs. 63.9% of infliximab patients (P = 0.077) and in 77.7% of adalimumab vs. 77.3% in infliximab group (P = 0.957), respectively. In ulcerative colitis, clinical remission was maintained in 50.0% of adalimumab vs. 65.8% of infliximab patients (P < 0.000); mucosal healing and steroid-free remission were maintained in 80.6% of adalimumab vs. 77.0% of infliximab patients (P = 0.494) and in 90.2% of adalimumab vs. 87.5% of infliximab patients (P = 0.662), respectively. At the multivariate analysis, ileocolonic location and simple endoscopic score for Crohn's disease >10 were predictors of failure in Crohn's disease; treatment with adalimumab, BMI ≥30 and Mayo score >10 were predictors of failure in ulcerative colitis. infliximab was more likely to cause adverse events than adalimumab (16.6 vs. 6.2%, P < 0.000).

CONCLUSION

Both adalimumab and infliximab are effective in long-term outpatients management of inflammatory bowel diseases. Adalimumab had a lower rate of adverse events.

摘要

背景

英夫利昔单抗和阿达木单抗被广泛用于治疗克罗恩病和溃疡性结肠炎。

目的

在反映真实临床实践的大规模克罗恩病和溃疡性结肠炎患者队列中比较英夫利昔单抗和阿达木单抗的长期疗效和安全性。

方法

回顾性分析 712 例患者,其中 410 例克罗恩病(268 例接受阿达木单抗治疗,142 例接受英夫利昔单抗治疗;中位随访 60 个月,范围 36-72),302 例溃疡性结肠炎(118 例接受阿达木单抗治疗,184 例接受英夫利昔单抗治疗;中位随访 48 个月,范围 36-84)。

结果

在克罗恩病中,阿达木单抗组的临床缓解率为 75.0%,英夫利昔单抗组为 72.5%(P=0.699);阿达木单抗组黏膜愈合和无激素缓解率为 49.5%,英夫利昔单抗组为 63.9%(P=0.077),阿达木单抗组为 77.7%,英夫利昔单抗组为 77.3%(P=0.957)。在溃疡性结肠炎中,阿达木单抗组的临床缓解率为 50.0%,英夫利昔单抗组为 65.8%(P<0.000);阿达木单抗组黏膜愈合和无激素缓解率为 80.6%,英夫利昔单抗组为 77.0%(P=0.494),阿达木单抗组为 90.2%,英夫利昔单抗组为 87.5%(P=0.662)。多变量分析显示,回结肠病变和克罗恩病简单内镜评分>10 是克罗恩病失败的预测因素;接受阿达木单抗治疗、BMI≥30 和 Mayo 评分>10 是溃疡性结肠炎失败的预测因素。英夫利昔单抗比阿达木单抗更易发生不良反应(16.6%比 6.2%,P<0.000)。

结论

阿达木单抗和英夫利昔单抗在炎症性肠病的长期门诊管理中均有效。阿达木单抗的不良反应发生率较低。

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