Comparing Patient-Reported Outcomes Among Anti-TNF Experienced Patients With Ulcerative Colitis Initiating Vedolizumab Versus Tofacitinib.

IF 1.8 Q3 GASTROENTEROLOGY & HEPATOLOGY
Michael D Kappelman, Millie D Long, Xian Zhang, Feng-Chang Lin, Laura Weisbein, Wenli Chen, Jessica Burris, Jennifer E Dorand, Lauren E Parlett, Tara Fehlmann, Colleen M Brensinger, Kevin Haynes, Vinit Nair, Alan F Kaul, Angela Dobes, James D Lewis
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引用次数: 0

Abstract

Background: Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy.

Objective: We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs).

Methods: We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy.

Results: We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (P = .04), but not Fatigue (P = .53) was lower among tofacitinib initiators. A trend toward higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups.

Conclusions: Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.

比较抗肿瘤坏死因子经验的溃疡性结肠炎患者启动Vedolizumab与托法替尼的患者报告的结果
背景:对抗肿瘤坏死因子(TNF)治疗的原发性和继发性无反应在溃疡性结肠炎(UC)患者中很常见,但有限的研究比较了后续生物治疗的有效性。目的:我们试图比较vedolizumab和tofacitinib在抗tnf经验的UC患者中的有效性,重点关注患者优先的患者报告结果(PROs)。方法:我们在克罗恩和结肠炎基金会的IBD合作伙伴和SPARC IBD计划中进行了一项前瞻性队列研究。我们确定了有抗tnf经历的UC患者开始使用维多单抗或托法替尼,并分析了大约6个月后报告的PROs(最少4个月,最多10个月)。共同主要结局是患者报告的结果测量信息系统(PROMIS)疲劳和疼痛干扰域。次要结局包括PRO2、治疗持续性和结肠切除术的需要。结果:我们比较了72种vedolizumab启动剂和33种tofacitinib启动剂。在随访中,托法替尼起始组的疼痛干扰(P = 0.04)较低,而疲劳(P = 0.53)较低。社会角色满意度的上升趋势不显著。其余的次要结局(PRO2,治疗持久性,结肠切除术)在治疗组之间没有差异。结论:在抗tnf经历的UC患者中,托法替尼使用者在治疗开始后4-10个月的疼痛干扰低于维多单抗使用者。许多(但不是全部)次要终点和亚分析也支持法替尼。未来需要更大样本量的研究来进一步评估这些发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Crohn's & Colitis 360
Crohn's & Colitis 360 Medicine-Gastroenterology
CiteScore
2.50
自引率
0.00%
发文量
41
审稿时长
12 weeks
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