Comparative real-world effectiveness of vedolizumab and ustekinumab for patients with ulcerative colitis: a GETAID multicentre cohort study

Abstract

Introduction

There are currently no comparative data on the efficacy and safety of vedolizumab and ustekinumab in ulcerative colitis (UC) after anti-TNF therapy fails.

Methods

We retrieved the full datasets of two observational, multicentre, retrospective studies of patients with UC for whom anti-TNF therapy failed and the patients were then treated with either vedolizumab or ustekinumab. The outcomes included steroid-free clinical remission, clinical remission, treatment persistence, colectomy, hospitalization, and serious and infectious adverse events. Propensity scores weighted comparison was applied.

Results

In total, 121 patients were included in the vedolizumab group and 97 were included in the ustekinumab group. At week 14 and week 52, in the weighted cohort, no difference was found between vedolizumab and ustekinumab for steroid-free clinical remission (OR = 0.55 [0.21–1.41], p = .21 and 0.94 [0.40–2.22], p = .89, respectively). There was no difference between vedolizumab and ustekinumab for secondary outcomes such as clinical remission, hospitalization, UC-related surgery, treatment persistence and serious and infectious adverse events.

Conclusion

In patients with UC for whom anti-TNF therapy failed, no difference was found between vedolizumab and ustekinumab after propensity scores weighted comparison. Further studies are required to determine predictive factors of the efficacy of both biological agents.

Keywords:

• Ulcerative colitis
• ustekinumab
• maintenance therapy
• effectiveness
• safety

Author contributions

Conception and design of the study: AM, AA. Generation, Collection, Assembly, Analysis and/or Interpretation of data: AM, AA, LPB, JF, RA, YB, MS, DL, XR, BP, VA, GC, SN, MF, MA, CG, LV, GS, SN, AB, SV, AB, GB, AB. Drafting or revision of the manuscript: AM, AA, LPB, JF, RA, YB, MS, DL, CG, XR, BP, VA, GC, SN, MF, MA, LV, GS, SN, AB, SV, AB, GB, AB. Approval of the final version of the manuscript: AM, AA, LPB, JF, RA, YB, MS, DL, XR, BP, VA, GC, SN, MF, MA, CG, LV, GS, SN, AB, SV, AB, GB, AB.

Disclosure statement

Laurent Peyrin-Biroulet received consulting fees from Merck, Abbvie, Janssen, Genentech, Ferring, Norgine, Tillots, Vifor, Shire, Therakos, Pharmacosmos, Pilège, BMS, UCB-Pharma, Hospira, Celltrion, Takeda, Biogaran, Boerhinger-Ingelheim, Lilly, Pfizer, and HAC-Pharma. This author also received lecture fees from Merck, Abbvie, Takeda, Janssen Cilag, Ferring, Norgine, Tillots, Vifor, Therakos, HAC-Pharma, and Mitsubishi. Jerome Filippi received lecture and consulting fees from Abbvie, Amgen, Astellas pharma, Biogen, Celltrion, Ferring, Janssen, MSD, Pfizer, Sandoz, Takeda. Romain Altwegg received board or lectures fees from Abbvie, Janssen, Pfizer, Takeda. Yoram Bouhnik received lecture and consulting fees from Abbvie, Biogaran, Boehringer-Ingelheim, CTMA, Ferring, Gilead, Hospira, ICON, Inception IBD, Janssen, Lilly, Mayoli Spindler, Merck, MSD, Norgine, Pfizer, Robarts Clinical Trials, Roche, Sanofi, Shire, Takeda, UCB and Vifor Pharma. This author has also stock ownership of Inception IBD, San Diego, CA, USA. David Laharie received counseling, boards or transports fees from Abbvie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, Tillots. Maria Nachury received board membership, consultancy, or lecture fees from Abbvie, Adacyte, Amgen, Arena, Biogen, CTMA, Celltrion, Ferring, Fresenius-Kabi, Janssen, Mayoli-Spindler, MSD, Pfizer, Takeda. Xavier Roblin reported a relationship with Abbvie, MSD, Janssen Cilag, and Takeda. Maria Nachury received consulting fees from AbbVie, MSD, Takeda, Janssen, Lilly, Pfizer, Biogaran, Mylan, Sandoz; and lecture fees: Abbvie, MSD, Takeda, Janssen, Mylan, Sandoz, Ferring. Vered Abitbol received lecture fees from Biogen Amgen Sandoz Mylan Pfizer Takeda Janssen Gilead Tillots. Guillaume Cadiot received consulting fees from AAA, Ipsen, Keocyt, Novartis and Pfizer and lecture fees from Abbvie, Ferring, Pfizer, Janssen, Takeda. Stephane Nancey received consulting fees from Merck, Abbvie, Takeda, Ferring, Norgine, Vifor Pharma, Novartis, Janssen-Cilag, Hospira, Takeda and HAC-Pharma. Mathurin Fumery has received lecture and consulting fees from Abbvie, MSD, Boehringer, Pfizer, Takeda, Celgene, Gilead, Celltrion, Amgen, Biogen, Pfizer, Lilly, Arena, Janssen and Ferring. Matthieu Allez has received honoraria from Novo Nordisk, MSD, Abbvie, Ferring, Genentech, Janssen, Pfizer, GSK, Hospira, UCB, Novartis, Takeda, Mayolo-Spindler. Cyrielle Gilletta received lecture fees from Abbvie, Takeda, Pfizer and Janssen and consulting fees from Abbvie, Janssen and Celltrion. Lucine Vuitton received lecture fees from Abbvie, MSD, Takeda, Ferring, Mayoli, Janssen and Pfizer, and research grants from MSD, Takeda and Pfizer. Guillaume Savoye has received lecture fees from Vifor Pharma, Takeda, Pfizer, HAC Pharma, Abbvie, MSD, and Ferring France. This author has also received travel accommodations from Ferring, Abbvie, and MSD France as well as a research grant from Ferring. Stephanie Viennot has received consulting fees from Abbvie, MSD, Takeda, Vifor Pharma and Ferring. Anthony Buisson has received research funding from Pfizer, lecture fees from Abbvie, Ferring, Hospira, MSD, Janssen, Sanofi-Aventis, Takeda and Vifor Pharma and consulting fees from Abbvie, Biogen, Janssen, Pfizer and Takeda. Guillaume Bouguen received lecture fees from Abbvie, Ferring, MSD, Takeda and Pfizer and consultant fees from Takeda, Janssen, Sandoz and Mylan. Arnaud Bourreille received counselling, boards or transport fees from Abbvie, Janssen, Ferring, MSD, Novartis, Pfizer, Takeda and Tillotts Pharma. Aurelien Amiot received consulting fees from Abbvie, Hospira, Janssen, Tillotts, Pfizer, Takeda, Gilead and Biocodex as well as lecture fees and travel accommodations from Abbvie, Janssen, Biocodex, Hospira, Ferring, Pfizer, Biogen, Amgen, Fresenius Kabi, Ferring, Tillotts, Takeda and MSD. This author also received advisory board fees from Gilead, Tillotts, Takeda and Abbvie. No conflicts of interest are claimed by the remaining authors.