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

V.B.C. Biemans; C.J. van der Woude; G. Dijkstra; A.E. van der Meulen-de Jong; M. Lowenberg; N.K. de Boer; B. Oldenburg; N. Srivastava; J.M. Jansen; A.G.L. Bodelier; R.L. West; A.C. de Vries; J.J.L. Haans; D. de Jong; F. Hoentjen; M.J. Pierik; Dutch Initiative Crohn and Colitis

doi:10.1111/apt.15745

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

V.B.C. Biemans, C.J. van der Woude, G. Dijkstra, A.E. van der Meulen-de Jong, M. Lowenberg, N.K. de Boer, B. Oldenburg, N. Srivastava, J.M. Jansen, A.G.L. Bodelier, R.L. West, A.C. de Vries, J.J.L. Haans, D. de Jong, F. Hoentjen, M.J. Pierik^*, Dutch Initiative Crohn and Colitis

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Pages (from-to)	123-134
Number of pages	12
Journal	Alimentary Pharmacology & Therapeutics
Volume	52
Issue number	1
DOIs	https://doi.org/10.1111/apt.15745
Publication status	Published - 1 Jul 2020

Keywords

adalimumab
dose intensification
induction
inflammatory-bowel-disease
maintenance therapy
DOSE INTENSIFICATION
INFLAMMATORY-BOWEL-DISEASE
ADALIMUMAB
INDUCTION
MAINTENANCE THERAPY

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Biemans, V. B. C., van der Woude, C. J., Dijkstra, G., van der Meulen-de Jong, A. E., Lowenberg, M., de Boer, N. K., Oldenburg, B., Srivastava, N., Jansen, J. M., Bodelier, A. G. L., West, R. L., de Vries, A. C., Haans, J. J. L., de Jong, D., Hoentjen, F., Pierik, M. J., & Dutch Initiative Crohn and Colitis (2020). Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment. Alimentary Pharmacology & Therapeutics, 52(1), 123-134. https://doi.org/10.1111/apt.15745

@article{8bd0a9746c6f4480af55fe975450601e,

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

abstract = "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.",

keywords = "adalimumab, dose intensification, induction, inflammatory-bowel-disease, maintenance therapy, DOSE INTENSIFICATION, INFLAMMATORY-BOWEL-DISEASE, ADALIMUMAB, INDUCTION, MAINTENANCE THERAPY",

author = "V.B.C. Biemans and {van der Woude}, C.J. and G. Dijkstra and {van der Meulen-de Jong}, A.E. and M. Lowenberg and {de Boer}, N.K. and B. Oldenburg and N. Srivastava and J.M. Jansen and A.G.L. Bodelier and R.L. West and {de Vries}, A.C. and J.J.L. Haans and {de Jong}, D. and F. Hoentjen and M.J. Pierik and {Dutch Initiative Crohn and Colitis}",

note = "Funding Information: No funding has been received for this specific study. Data have been generated as part of routine work of the participating organisations. We thank Bjorn Winkens for his assistance in the statistical analyses. 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. L?wenberg 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. Funding Information: 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. L{\"o}wenberg 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. Declaration of personal interests: Publisher Copyright: {\textcopyright} 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd",

year = "2020",

month = jul,

day = "1",

doi = "10.1111/apt.15745",

language = "English",

volume = "52",

pages = "123--134",

journal = "Alimentary Pharmacology & Therapeutics",

issn = "0269-2813",

publisher = "Wiley",

number = "1",

}

Biemans, VBC, van der Woude, CJ, Dijkstra, G, van der Meulen-de Jong, AE, Lowenberg, M, de Boer, NK, Oldenburg, B, Srivastava, N, Jansen, JM, Bodelier, AGL, West, RL, de Vries, AC, Haans, JJL, de Jong, D, Hoentjen, F, Pierik, MJ & Dutch Initiative Crohn and Colitis 2020, 'Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment', Alimentary Pharmacology & Therapeutics, vol. 52, no. 1, pp. 123-134. https://doi.org/10.1111/apt.15745

Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn's disease patients with prior failure to anti-TNF treatment. / Biemans, V.B.C.; van der Woude, C.J.; Dijkstra, G. et al.
In: Alimentary Pharmacology & Therapeutics, Vol. 52, No. 1, 01.07.2020, p. 123-134.

Research output: Contribution to journal › Article › Academic › peer-review

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 - Biemans, V.B.C.

AU - van der Woude, C.J.

AU - Dijkstra, G.

AU - van der Meulen-de Jong, A.E.

AU - Lowenberg, M.

AU - de Boer, N.K.

AU - Oldenburg, B.

AU - Srivastava, N.

AU - Jansen, J.M.

AU - Bodelier, A.G.L.

AU - West, R.L.

AU - de Vries, A.C.

AU - Haans, J.J.L.

AU - de Jong, D.

AU - Hoentjen, F.

AU - Pierik, M.J.

AU - Dutch Initiative Crohn and Colitis

N1 - Funding Information: No funding has been received for this specific study. Data have been generated as part of routine work of the participating organisations. We thank Bjorn Winkens for his assistance in the statistical analyses. 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. L?wenberg 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. Funding Information: 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. Declaration of personal interests: Publisher Copyright: © 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd

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 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.

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 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.

KW - adalimumab

KW - dose intensification

KW - induction

KW - inflammatory-bowel-disease

KW - maintenance therapy

KW - DOSE INTENSIFICATION

KW - INFLAMMATORY-BOWEL-DISEASE

KW - ADALIMUMAB

KW - INDUCTION

KW - MAINTENANCE THERAPY

U2 - 10.1111/apt.15745

DO - 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 -