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一项在溃疡性结肠炎患者中比较维得利珠单抗、阿达木单抗和古利昔单抗的倾向评分加权比较。

A propensity score weighted comparison of Vedolizumab, Adalimumab, and Golimumab in patients with ulcerative colitis.

机构信息

Inflammatory bowel disease Unit, A.O.O.R. "Villa Sofia-Cervello", Viale Strasburgo 233, 90146 Palermo, Italy.

Inflammatory bowel disease Unit, A.O.O.R. "Villa Sofia-Cervello", Viale Strasburgo 233, 90146 Palermo, Italy.

出版信息

Dig Liver Dis. 2020 Dec;52(12):1461-1466. doi: 10.1016/j.dld.2020.06.014. Epub 2020 Jun 26.

Abstract

BACKGROUND

No real-life study on the comparative effectiveness of Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL) in ulcerative colitis (UC) is currently available.

AIMS

To compare the effectiveness of the three biologics in consecutive patients with UC.

METHODS

A three-arms propensity score-adjusted analysis was performed using the Inverse Probability of Treatment Weighting method.

RESULTS

463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included (median follow-up: 47.6 weeks). At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons). At 52 weeks (n = 377), a steroid-free remission was reported in 51.5% patients in the VDZ group, in 31.2% patients in the ADA group, and in 29.4% patients in the GOL group (p = 0.002 for VDZ vs. ADA, p = 0.001 for VDZ vs. GOL, p = n.s. for ADA vs. GOL). Cox survival analysis demonstrated that patients treated with VDZ had reduced probability of treatment discontinuation compared to those treated with ADA (HR: 0.42, 95% CI 0.28-0.64, p < 0.001) and GOL (HR: 0.30, 95% CI 0.19-0.46, p < 0.001), while patients treated with ADA had reduced risk of treatment discontinuation compared to those treated with GOL (HR: 0.71, 95% CI 0.50-1.00, p = 0.048).

CONCLUSIONS

VDZ was superior to ADA and GOL at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared to GOL.

摘要

背景

目前尚无维得利珠单抗(VDZ)、阿达木单抗(ADA)和古利昔单抗(GOL)在溃疡性结肠炎(UC)中比较疗效的真实世界研究。

目的

比较三种生物制剂在连续 UC 患者中的疗效。

方法

采用逆概率治疗权重法进行三臂倾向评分调整分析。

结果

纳入 463 例治疗(VDZ:n=187;ADA:n=168;GOL:n=108)(中位随访:47.6 周)。12 周时(n=463),VDZ 组、ADA 组和 GOL 组分别有 24.1%、33.3%和 30.6%的患者达到无激素缓解(所有比较均为 p=无统计学意义)。52 周时(n=377),VDZ 组、ADA 组和 GOL 组分别有 51.5%、31.2%和 29.4%的患者达到无激素缓解(VDZ 与 ADA 比较,p=0.002;VDZ 与 GOL 比较,p=0.001;ADA 与 GOL 比较,p=无统计学意义)。Cox 生存分析显示,与 ADA 和 GOL 相比,VDZ 治疗患者停药的概率降低(HR:0.42,95%CI 0.28-0.64,p<0.001)和 GOL(HR:0.30,95%CI 0.19-0.46,p<0.001),而 ADA 治疗患者停药风险低于 GOL 治疗患者(HR:0.71,95%CI 0.50-1.00,p=0.048)。

结论

52 周时,VDZ 在疗效和治疗持续时间方面优于 ADA 和 GOL,而 ADA 在治疗持续时间方面优于 GOL。

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