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在中重度溃疡性结肠炎中,作为一线生物制剂时,维多珠单抗的持久性比英夫利昔单抗更长,但作为二线生物制剂时则不然:来自澳大利亚全国炎症性肠病队列持久性(PANIC)研究的真实世界注册数据。

Vedolizumab has longer persistence than infliximab as a first-line biological agent but not as a second-line biological agent in moderate-to-severe ulcerative colitis: real-world registry data from the Persistence Australian National IBD Cohort (PANIC) study.

作者信息

Pudipeddi Aviv, Ko Yanna, Paramsothy Sudarshan, Leong Rupert W

机构信息

Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, NSW, Australia.

Gastroenterology and Liver Services, Concord Repatriation General Hospital, Hospital Road, Concord, Sydney, NSW 2139, Australia.

出版信息

Therap Adv Gastroenterol. 2022 Mar 8;15:17562848221080793. doi: 10.1177/17562848221080793. eCollection 2022.

Abstract

BACKGROUND

The choice between infliximab (IFX) and vedolizumab (VED) as a first-line biological agent in moderate-to-severe ulcerative colitis (UC) can be difficult. Second-line vedolizumab (VED) efficacy may decline following prior infliximab (IFX) treatment failure in UC patients. However, it is not known whether second-line IFX efficacy declines after failure of first-line VED.

AIMS

We aimed to compare first-line and second-line persistence of IFX and VED, in particular whether second-line IFX persistence declines after failure of first-line VED.

METHODS

Persistence of IFX and VED was analysed from the Australian Pharmaceutical Benefits Scheme registry data as either first- or second-line treatment in UC. Propensity score matching (1:1) was conducted in the comparison of first-line treatments. Cox proportional hazard regression analysis was used to identify significant predictors and expressed as a hazard ratio (HR and 95% CI).

RESULTS

There were 420 subjects with moderate-to-severe UC who received either first-line IFX ( = 251) or VED ( = 169), with 774 patient-years of follow-up. First-line VED had significantly longer persistence than first-line IFX (>50.2 22.2 months,  = 0.001). Fifty-three subjects failed first-line IFX and swapped to second-line VED (IFX→VED group). Twenty-two subjects failed first-line VED group and swapped to second-line IFX (VED→IFX group). First-line VED persistence was significantly longer than second-line VED (>50.2 32.0 months,  = 0.03), but first-line IFX persistence was not statistically significantly different to second-line IFX (27.6 months  > 38.6 months,  = 0.30). Immunomodulator co-therapy was significantly associated with a lower risk of nonpersistence of first-line VED (HR: 0.55, 95% CI: 0.33-0.89,  = 0.02) and IFX (HR: 0.63,95%CI: 0.33-0.92,  = 0.02).

CONCLUSION

VED had a significantly longer persistence than IFX as first-line biological agent but does not disadvantage second-line IFX use in moderate-to-severe UC. VED after IFX is associated with significantly poorer persistence. VED, therefore, should be considered as the first-line biological agent of choice in UC.

摘要

背景

在中重度溃疡性结肠炎(UC)中,选择英夫利昔单抗(IFX)还是维多珠单抗(VED)作为一线生物制剂可能具有挑战性。在UC患者中,若先前英夫利昔单抗(IFX)治疗失败,二线使用维多珠单抗(VED)的疗效可能会下降。然而,尚不清楚一线VED治疗失败后二线IFX的疗效是否会下降。

目的

我们旨在比较IFX和VED一线及二线治疗的持续时间,特别是一线VED治疗失败后二线IFX的持续时间是否会下降。

方法

从澳大利亚药品福利计划登记数据中分析IFX和VED作为UC一线或二线治疗的持续时间。在一线治疗的比较中进行倾向得分匹配(1:1)。采用Cox比例风险回归分析确定显著预测因素,并以风险比(HR和95%CI)表示。

结果

420例中重度UC患者接受了一线IFX(n = 251)或VED(n = 169)治疗,随访时间为774患者年。一线VED的持续时间显著长于一线IFX(>50.2对22.2个月,P = 0.001)。53例患者一线IFX治疗失败后换用二线VED(IFX→VED组)。22例患者一线VED治疗失败后换用二线IFX(VED→IFX组)。一线VED的持续时间显著长于二线VED(>50.2对32.0个月,P = 0.03),但一线IFX的持续时间与二线IFX无统计学显著差异(27.6个月对>38.6个月,P = 0.30)。免疫调节剂联合治疗与一线VED(HR:0.55,95%CI:0.33 - 0.89,P = 0.02)和IFX(HR:0.63,95%CI:0.33 - 0.92,P = 0.02)治疗不持续的风险较低显著相关。

结论

作为一线生物制剂,VED的持续时间显著长于IFX,但在中重度UC中二线使用IFX并无劣势。IFX治疗后使用VED与持续时间显著较差相关。因此,VED应被视为UC一线生物制剂的首选。

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