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生物制剂初治克罗恩病患者中英夫利昔单抗与阿达木单抗的疗效比较。

Comparative Effectiveness of Infliximab Versus Adalimumab in Patients with Biologic-Naïve Crohn's Disease.

机构信息

Division of Gastroenterology, Montreal General Hospital, McGill University Health Center, 1650, Cedar Avenue, C7-200, Montreal, QC, H3G 1A4, Canada.

Haya Al-Habeeb Gastroenterology Center, Mubarak Al-Kabeer Hospital, Jabriya, Kuwait.

出版信息

Dig Dis Sci. 2018 May;63(5):1302-1310. doi: 10.1007/s10620-017-4874-6. Epub 2017 Dec 14.

Abstract

BACKGROUND

Direct head-to-head studies comparing the long-term outcomes of infliximab (IFX) to adalimumab (ADA) in Crohn's disease (CD) are sparse.

AIMS

We compared the short-term and long-term efficacy and safety of IFX and ADA in CD.

METHODS

We performed a single-center retrospective study including biologic-naïve adult patients with CD who were started on IFX or ADA at the McGill University Health Center. The primary end points were clinical response and remission at 12 months. Secondary end points included corticosteroid-free remission at 12 months, durable remission, and treatment failure with need for steroids, hospitalization or surgery. Safety was also assessed.

RESULTS

Two hundred and twenty patients were included (143 IFX, 77 ADA). Patients on IFX had a higher prevalence of fistulizing or perianal disease and corticosteroid treatment at baseline. Rates of clinical remission and corticosteroid-free remission at 12 months were similar between both groups: 63.8 versus 76.3% (p = 0.139) and 54.1 versus 44.7% (p = 0.354), respectively, for IFX and ADA. Combination therapy led to significantly higher remission rates at 12 months compared to monotherapy for patients on IFX (81.2 vs. 52.1%, p = 0.008), but not for those on ADA. Higher rates of adverse events were reported with IFX compared to ADA (p = 0.006).

CONCLUSIONS

Our real-life experience in biologic-naïve CD patients demonstrated that patients started on IFX were more likely to have a harder-to-treat phenotype. Despite that, efficacy end points were similar between both groups. Clinical remission was higher in patients with combination therapy for IFX, but not for those on ADA. This warrants further investigation.

摘要

背景

直接比较英夫利昔单抗(IFX)和阿达木单抗(ADA)治疗克罗恩病(CD)长期疗效的头对头研究较少。

目的

比较 IFX 和 ADA 在 CD 中的短期和长期疗效和安全性。

方法

我们进行了一项单中心回顾性研究,纳入了在麦吉尔大学健康中心接受 IFX 或 ADA 治疗的生物初治成年 CD 患者。主要终点为 12 个月时的临床缓解和缓解。次要终点包括 12 个月时无皮质激素缓解、持久缓解和需要激素、住院或手术治疗的治疗失败。还评估了安全性。

结果

共纳入 220 例患者(IFX 组 143 例,ADA 组 77 例)。IFX 组患者在基线时更常见瘘管或肛周疾病和皮质激素治疗。两组患者在 12 个月时的临床缓解率和无皮质激素缓解率相似:IFX 组为 63.8%和 76.3%(p=0.139),ADA 组为 54.1%和 44.7%(p=0.354)。IFX 组联合治疗的缓解率显著高于单药治疗(81.2%比 52.1%,p=0.008),而 ADA 组则无差异。IFX 组的不良反应发生率高于 ADA 组(p=0.006)。

结论

我们在生物初治 CD 患者中的真实世界经验表明,接受 IFX 治疗的患者更有可能具有更难治疗的表型。尽管如此,两组的疗效终点相似。IFX 联合治疗的患者临床缓解率更高,但 ADA 组则不然。这需要进一步研究。

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