Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment

被引:113
作者
Biemans, Vince B. C. [1 ,2 ]
van der Woude, C. Janneke [3 ]
Dijkstra, Gerard [4 ]
van der Meulen-de Jong, Andrea E. [5 ]
Lowenberg, Mark [6 ]
de Boer, Nanne K. [7 ]
Oldenburg, Bas [8 ]
Srivastava, Nidhi [9 ]
Jansen, Jeroen M. [10 ]
Bodelier, Alexander G. L. [11 ]
West, Rachel L. [12 ]
de Vries, Annemarie C. [3 ]
Haans, Jeoffrey J. L. [2 ]
de Jong, Dirk [1 ]
Hoentjen, Frank [1 ]
Pierik, Marieke J. [2 ]
机构
[1] Radboud Univ Nijmegen, Dept Gastroenterol & Hepatol, Med Ctr, Nijmegen, Netherlands
[2] Maastricht Univ, Dept Gastroenterol & Hepatol, Med Ctr, POB 5800, NL-6202 AZ Maastricht, Netherlands
[3] Erasmus MC, Rotterdam, Netherlands
[4] Univ Med Ctr Groningen, Groningen, Netherlands
[5] Leiden Univ, Med Ctr, Leiden, Netherlands
[6] Univ Amsterdam, Acad Med Ctr, Med Ctr, Amsterdam, Netherlands
[7] Vrije Univ Amsterdam, Amsterdam Univ, Amsterdam Gastroenterol & Metab Res Inst, Med Ctr, Amsterdam, Netherlands
[8] Univ Med Ctr Utrecht, Utrecht, Netherlands
[9] Haaglanden Med Ctr, The Hague, Netherlands
[10] Onze Lieve Vrouw Hosp, Amsterdam, Netherlands
[11] Amphia Hosp, Breda, Netherlands
[12] Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands
关键词
INFLAMMATORY-BOWEL-DISEASE; MAINTENANCE THERAPY; DOSE INTENSIFICATION; INDUCTION; ADALIMUMAB;
D O I
10.1111/apt.15745
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background Both vedolizumab and ustekinumab can be considered for the treatment of Crohn's disease (CD) when anti-TNF treatment fails. However, head-to-head trials are currently not available or planned. Aim To compare vedolizumab and ustekinumab in Crohn ' s disease patients in a prospective registry specifically developed for comparative studies with correction for confounders. Methods Crohn ' s disease patients, who failed anti-TNF treatment and started vedolizumab or ustekinumab in standard care as second-line biological, were identified in the observational prospective Dutch Initiative on Crohn and Colitis Registry. Corticosteroid-free clinical remission (Harvey Bradshaw Index <= 4), biochemical remission (C-reactive protein <= 5 mg/L and fecal calprotectin <= 250 mu g/g), combined corticosteroid-free clinical and biochemical remission, and safety outcomes were compared after 52 weeks of treatment. To adjust for confounding and selection bias, we used multiple logistic regression and propensity score matching. Results In total, 128 vedolizumab- and 85 ustekinumab-treated patients fulfilled the inclusion criteria. After adjusting for confounders, ustekinumab-treated patients were more likely to achieve corticosteroid-free clinical remission (odds ratio [OR]: 2.58, 95% CI: 1.36-4.90, P = 0.004), biochemical remission (OR: 2.34, 95% CI: 1.10-4.96, P = 0.027), and combined corticosteroid-free clinical and biochemical remission (OR: 2.74, 95% CI: 1.23-6.09, P = 0.014), while safety outcomes (infections: OR: 1.26, 95% CI: 0.63-2.54, P = 0.517; adverse events: OR: 1.33, 95% CI: 0.62-2.81, P = 0.464; hospitalisations: OR: 0.67, 95% CI: 0.32-1.39, P = 0.282) were comparable between the two groups. The propensity score matched cohort with sensitivity analyses showed comparable results. Conclusion Ustekinumab was associated with superior effectiveness outcomes when compared to vedolizumab while safety outcomes were comparable after 52 weeks of treatment in CD patients who have failed anti-TNF treatment.
引用
收藏
页码:123 / 134
页数:12
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