Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naive Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

被引：114

作者：

Bressler, Brian ^{[1
]}

Yarur, Andres ^{[2
]}

Silverberg, Mark S. ^{[3
]}

Bassel, Marielle ^{[4
]}

Bellaguarda, Emanuelle ^{[5
]}

Fourment, Chris ^{[6
]}

Gatopoulou, Anthie ^{[7
]}

Karatzas, Pantelis ^{[8
]}

Kopylov, Uri ^{[9
,10
]}

Michalopoulos, George ^{[11
]}

Michopoulos, Spyridon ^{[12
]}

Navaneethan, Udayakumar ^{[13
]}

Rubin, David T. ^{[14
]}

Siffledeen, Jesse ^{[15
]}

Singh, Andrew ^{[16
]}

Soufleris, Konstantinos ^{[17
]}

Stein, Dara ^{[18
]}

Demuth, Dirk ^{[19
]}

Mantzaris, Gerassimos J. ^{[20
]}

机构：

[1] St Pauls Hosp, Vancouver, BC, Canada

[2] Med Coll Wisconsin, Milwaukee, WI 53226 USA

[3] Univ Toronto, Mt Sinai Hosp, Toronto, ON, Canada

[4] Evidera, Montreal, PQ, Canada

[5] Northwestern Univ, Feinberg Sch Med, Evanston, IL USA

[6] Texas Digest Dis Consultants, Southlake, TX USA

[7] Democritus Univ Thrace, Univ Hosp Alexandroupolis, Alexandroupolis, Greece

[8] Laikon Gen Hosp, Athens, Greece

[9] Sheba Med Ctr Ramat Gan, Tel Aviv, Israel

[10] Sackler Sch Med, Tel Aviv, Israel

[11] Tzane Gen Hosp Piraeus, Piraeus, Greece

[12] Alexandra Reg Gen Hosp, Athens, Greece

[13] Advent Hlth, Orlando, FL USA

[14] Univ Chicago Med, Inflammatory Bowel Dis Ctr, Chicago, IL USA

[15] Covenant Hlth Grey Nuns Community Hosp, Div Gastroenterol, Edmonton, AB, Canada

[16] PerCuro Clin Res, Victoria, BC, Canada

[17] Theagenio Anticanc Hosp Thessaloniki, Thessaloniki, Greece

[18] Evidera, London, England

[19] Takeda Pharmaceut Int Singapore, Singapore, Singapore

[20] Evangelismos Med Ctr, Athens, Greece

来源：

JOURNAL OF CROHNS & COLITIS | 2021年 / 15卷 / 10期

关键词：

Vedolizumab; biologic-naive; real-world effectiveness; MAINTENANCE THERAPY; INDUCTION;

D O I：

10.1093/ecco-jcc/jjab058

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Background and Aims: This study aimed to compare real-world clinical effectiveness and safety of vedolizumab, an alpha 4 beta 7-integrin inhibitor, and anti-tumour necrosis factor-alpha [anti-TNF alpha] agents in biologic-naive ulcerative colitis [UC] and Crohn's disease [CD] patients. Methods: This was a 24-month retrospective medical chart study in adult UC and CD patients treated with vedolizumab or anti-TNF alpha in Canada, Greece and the USA. Inverse probability weighting was used to account for differences between groups. Primary outcomes were cumulative rates of clinical effectiveness [clinical response, clinical remission, mucosal healing] and incidence rates of serious adverse events [SAEs] and serious infections [SIs]. Secondary outcomes included cumulative rates of treatment persistence [patients who did not discontinue index treatment during follow-up] and dose escalation and incidence rates of disease exacerbations and disease-related surgeries. Adjusted analyses were performed using inverse probability weighting. Results: A total of 1095 patients [604 UC, 491 CD] were included. By 24 months, rates of clinical effectiveness were similar between groups, but incidence rates of SAEs (hazard ratio [HR] = 0.42 [0.28-0.62]) and SIs (HR = 0.40 [0.19-0.85]) were significantly lower in vedolizumab vs anti-TNF alpha patients. Rates of treatment persistence [p < 0.01] by 24 months were higher in vedolizumab patients with UC. Incidence rates of disease exacerbations were lower in vedolizumab patients with UC (HR = 0.58 [0.45-0.76]). Other outcomes did not significantly differ between groups. Conclusion: In this real-world setting, first-line biologic therapy in biologic-naive patients with UC and CD demonstrated that vedolizumab and anti-TNF alpha treatments were equally effective at controlling disease symptoms, but vedolizumab has a more favourable safety profile.

引用

页码：1694 / 1706

页数：13

共 21 条

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