TY - JOUR
T1 - Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn’s disease patients with prior failure to anti-TNF treatment
AU - the Dutch Initiative on Crohn and Colitis (ICC)
AU - Biemans, Vince B. C.
AU - van der Woude, C. Janneke
AU - Dijkstra, Gerard
AU - van der Meulen-de Jong, Andrea E.
AU - Löwenberg, Mark
AU - de Boer, Nanne K.
AU - Oldenburg, Bas
AU - Srivastava, Nidhi
AU - Jansen, Jeroen M.
AU - Bodelier, Alexander G. L.
AU - West, Rachel L.
AU - de Vries, Annemarie C.
AU - Haans, Jeoffrey J. L.
AU - de Jong, Dirk
AU - Hoentjen, Frank
AU - Pierik, Marieke J.
N1 - Funding Information: Declaration of personal interests: V.B.C. Biemans has no conflicts of interest to declare. C.J. van der Woude has served on advisory boards and/or received financial compensation from the following companies: MSD, FALK Benelux, Abbott laboratories, Mundipharma Pharmaceuticals, Janssen, Takeda, and Ferring during the last 3 years. A.E. van der Meulen‐de Jong has served on advisory boards, or as speaker or consultant for Takeda, Tramedico, AbbVie, and has received grants from Takeda. G. Dijkstra unrestricted research grants from Abbvie, Takeda and Ferring Pharmaceuticals. Advisory boards for Mundipharma and Pharmacosmos. Received speakers fees from Takeda and Janssen Pharmaceuticals. M. Löwenberg has served as speaker and/or principal investigator for: Abbvie, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Gilead, GlaxoSmithKline, Janssen‐Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Takeda, Tillotts, Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Achmea healthcare and ZonMW. N.K.H. de Boer has served as a speaker for AbbVie, Takeda and MSD. He has served as consultant and principal investigator for Takeda and TEVA Pharma B.V. He has received (unrestricted) research grants from Dr. Falk and Takeda. B. Oldenburg speaker: Ferring, MSD, Abbvie. Advisory boards: Ferring, MSD, Abbvie, Takeda, Pfizer, Janssen. Research Grants: Abbvie, Ferring, Takeda, Pfizer, MSD, dr. Falk. N. Srivastava has no conflict of interest to declare. J.M. Jansen has served on advisory boards, or as speaker or consultant for Abbvie, Amgen, Ferring, Fresenius, Janssen, MSD, Pfizer, Takeda. A.G.L. Bodelier has served as speaker and/ or participant in advisory board for: Abbvie, Merck Sharp & Dohme, Takeda, Vifor Pharma, Mundipharma. R.L. West has participated in advisory board and/or received financial compensation from the following companies: Jansen and Abbvie. A.C. de Vries has participated in advisory board and/or received financial compensation from the following companies: Jansen, Takeda, Abbvie and Tramedico. D.J. de Jong Received consulting fees from Synthon, Pharma, Abbvie, and MSD, and travel fees from Falk Pharma, Takeda, Abbvie, MSD, Ferring, Vifor Pharma, and Cablon Medical. J.J.L. Haans reports personal fees from advisory board for Takeda Nederland B.V., personal fees from advisory board for Lamepro B.V., outside the submitted work. F. Hoentjen has served on advisory boards, or as speaker or consultant for Abbvie, Celgene, Janssen‐Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk , and has received unrestricted grants from Dr Falk, Janssen‐Cilag, Abbvie. M.J. Pierik has served on advisory boards, or as speaker or consultant for Abbvie, Janssen‐Cilag, MSD, Takeda, Ferring, Dr Falk, and Sandoz and has received unrestricted grants from, Janssen‐Cilag, Abbvie and Takeda outside the submitted work. Publisher Copyright: © 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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 µg/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. Conclusions: 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.
AB - 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 µg/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. Conclusions: 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.
UR - http://www.scopus.com/inward/record.url?scp=85085058311&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/apt.15745
DO - https://doi.org/10.1111/apt.15745
M3 - Article
C2 - 32441396
SN - 0269-2813
VL - 52
SP - 123
EP - 134
JO - Alimentary pharmacology & therapeutics
JF - Alimentary pharmacology & therapeutics
IS - 1
ER -