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EFFECTIVENESS OF VEDOLIZUMAB DOSE ESCALATION FOR CROHN’S DISEASE IN A LARGE-SCALE, CANADIAN REAL-WORLD COHORT

Hillary Steinhart 1, Edmond-Jean Bernard 2, Jean-Frédéric LeBlanc 3, pauline wils 4, Marie-Julie Allard 5, Abhinav Wadhwa 5, Ryan Ward 5, Ruth Moulson 6, Jessica Weiss 6, Chris Pettengell 6, Laurent Peyrin-Biroulet 7, Brian Bressler 8

Affiliations

1 University of Toronto, Toronto, Canada

2 Université de Montréal, Montréal, Canada|||Chum, Montréal, Canada

3 Université de Montréal, Montréal, Canada|||Sacré-Coeur Hospital, Montréal, Canada

4 Lille University Hospital, Lille, France

5 Takeda Canada, Toronto, Canada

6 Pentavere Research Group, Toronto, Canada

7 Nancy University Hospital, Vandoeuvre-les-Nancy, France

8 University of British Columbia, Vancouver, Canada

Summary

AI Generated

A Canadian real-world study of vedolizumab in Crohn's disease found that patients requiring dose escalation from every 8 weeks to every 4 weeks achieved lower remission rates than those remaining on standard dosing, with shorter baseline disease duration associated with better response to escalation.

At 14 weeks after vedolizumab initiation, remission rates were lower in the dose-escalation cohort compared to the standard-dosing cohort: 47% versus 61% in bio-naïve patients and 22% versus 48% in bio-experienced patients.
Among patients not in remission at the time of dose escalation to every 4 weeks, 33% achieved remission 3 months after escalation.
Shorter disease duration at baseline was significantly associated with achieving remission after dose escalation: median 8 months in responders versus 16 months in non-responders (p=0.007).
Treatment persistence at 24 months after dose escalation was 59% in bio-naïve and 53% in bio-experienced patients.
This prospective study followed 250 patients who escalated dosing and 116 who remained on standard dosing in a Canadian patient support program from 2015 to 2023.

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Abstract

Introduction

Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking drug indicated for Crohn's disease (CD), is administered intravenously at Weeks 0, 2, and 6, then every 8 weeks (Q8W). Dose escalation to every 4 weeks (Q4W) may recapture response to treatment in ~50% of patients with inadequate/loss of response. Factors associated with VDZ dose escalation from Q8W to Q4W and real-world outcomes remain underexplored.

Aims & Methods

Adults with moderate to severe CD initiating VDZ Q8W maintenance therapy were prospectively followed in a Canadian patient support program (2015-2023). Two cohorts were included: 1) patients escalated to Q4W during maintenance therapy any time after week 14 infusion (Q8W>Q4W maintenance) and 2) patients maintained on Q8W treatment for ≥2 years without dose escalation (Q8W maintenance). Baseline characteristics were summarized as median (range) and frequency (%) and compared between cohorts. Rates of clinical remission (Harvey-Bradshaw Index [HBI]<5) were described stratifying by prior biologic experience. Associations between baseline factors and clinical remission 3 months after Q4W dose escalation were assessed using Wilcoxon rank sum test and Fisher’s exact test. Treatment persistence at 12 and 24 months after treatment initiation and dose escalation were evaluated in the Q8W>Q4W cohort using Kaplan-Meier survival analysis.

Results

250 patients were included in the Q8W>Q4W maintenance cohort (39% bio-naïve), and 116 in the Q8W maintenance cohort (51% bio-naïve). In both cohorts, median age at treatment initiation was 50 years and baseline HBI score was 10. In the Q8W>Q4W maintenance cohort, median disease duration prior to initiation of treatment was 14 years (0-69) and median follow-up duration was 22 months (7-60). In the Q8W cohort, median disease and follow-up duration were 8 years (0-50) and 35 months (27-46), respectively. At 14 weeks post-treatment initiation, rates of remission in the Q8W>Q4W maintenance cohort were 47% (bio-naïve) and 22% (bio-experienced), and in the Q8W cohort 61% (bio-naïve) and 48% (bio-experienced) (Table 1). Among patients in the Q8W>Q4W maintenance cohort not in remission at the time of dose escalating, 33% achieved remission 3 months after dose escalation to Q4W. Disease duration at baseline was shorter in these patients than in those who did not achieve remission (8 months [0-52] vs. 16 months [0-69], p=0.007). In the Q8W>Q4W maintenance cohort, 12- and 24-month treatment persistence after treatment initiation was 91% and 64% (bio-naïve) and 94% and 67% (bio-experienced), respectively. After dose escalation, 12- and 24-month treatment persistence was 66% and 59% (bio-naïve) and 69% and 53% (bio-experienced) (Table 1).

Table 1. Rates of remission after treatment initiation and prior to dose escalation
	Bio-naïve- Q8W>Q4W Maintenance cohort (N=97)	Bio-naïve- Q8W Maintenance cohort (N=59)	Bio-experienced- Q8W>Q4W Maintenance cohort (N=153)	Bio-experienced- Q8W Maintenance cohort (N=57)
14-weeks remission, %	47%	61%	22%	48%
Missing, n	5	2	6	1
Time to remission in weeks, median (range)	6 (2-95)	6 (2-164)	14 (2-85)	14 (2-134)
Missing – do not achieve remission, n	21	5	66	3
12-month persistence after treatment initiation, %	91%	N/A	94%	N/A
24-month persistence after treatment initiation, n (%)	64%	N/A	67%	N/A
12-month persistence after dose escalation, %	66%	N/A	69%	N/A
24-month persistence after dose escalation, %	59%	N/A	53%	N/A

Conclusion

Patients with CD who underwent VDZ Q8W>Q4W dose escalation achieved lower rates of clinical remission than those remaining on Q8W treatment, and one third achieved clinical remission 3 months after dose escalating. Baseline disease duration was significantly associated with remission among those escalating to Q4W.

References

N/A

Disclosure

AHS: Advisory Board Membership/Consultant: Abbvie, Amgen, BioJAMP, BMS, Celltrion, Fresenius Kabi, Janssen, McKesson, Mylan Pharmaceuticals, Organon, Pendopharm, Roche, Pfizer, Sandoz, Takeda, Viatris, Speakers’ Bureau: Abbvie, Amgen, Ferring, Fresenius Kabi, Janssen, Organon, Pfizer, Sandoz, Takeda, Research Grants: Abbvie, Arena, Celgene/BMS, Genentech, Janssen, Roche, Takeda.
EJB: Participation in advisory boards or speaker services: Abbvie, Janssen, Takeda, Pfizer, Merck, Amgen, Pendopharm, Jamp, Fresenius, Kabi, Bausch Health, Celltrion, Eli Lilly, BMS, Grant/Research: Janssen, Abbvie, Any other investment or relationship that could be judged by a reasonable and knowledgeable participant to have the potential to influence the content of the training activity, Abbvie, Janssen, Takeda, Pfizer, Merck, Amgen, Pendopharm, Jamp, Fresenius, Kabi, Bausch Health, Celltrion, BMS.
JFL: AbbVie, BMS, Janssen, Frenesius-Kabi, Pfizer, Sandoz, Takeda. AHS: Advisory Board Membership/Consultant: Abbvie, Amgen, BioJAMP, BMS, Celltrion, Fresenius Kabi, Janssen, McKesson, Mylan Pharmaceuticals, Organon, Pendopharm, Roche, Pfizer, Sandoz, Takeda, Viatris, Speakers’ Bureau: Abbvie, Amgen, Ferring, Fresenius Kabi, Janssen, Organon, Pfizer, Sandoz, Takeda, Research Grants: Abbvie, Arena, Celgene/BMS, Genentech, Janssen, Roche, Takeda.
PW: Personal fees from AbbVie, Ferring, Biogen, and Janssen
MJA, AW, RW: were employees of Takeda Canada Inc. at the time of the study.
RM, JW, CP: were employees of Pentavere Research Group Inc. at the time of the study.
LPB: Consulting from AbbVie, Alimentiv, Alma Bio Therapeutics, Amgen, Applied Molecular Transport, Arena, Biogen, BMS, Celltrion, CONNECT Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, HACPharma, IAG Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Norgine, Novartis, OM Pharma, ONO Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Par’Immune, Pfizer, Prometheus, Protagonist, Roche, Sanofi, Sandoz, Takeda, Theravance, Thermo Fisher, Tigenix, Tillots, Viatris, Vifor, Ysopia, Abivax, Samsung, Ventyx, Roivant, and Vectivbio; grants from Takeda, Fresenius Kabi, and Celltrion; and lecture fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Sandoz, Biogen, MSD, Amgen, Vifor, Arena, Lilly, Gilead, Viatris, and Medac.
BB: Advisor/Speaker: Ferring, Janssen, Abbvie, Takeda, Pfizer, BMS, Merck, Sandoz, Organon, Lifelabs, Celltrion. Advisor: Alimentiv, Gilead, Iterative Health, AMT, Celgene, Merck, Amgen, Pendopharm, Eli Lilly, BMS, Fresenius Kabi, Mylan, Viatris, Bausch Health, Celltrion Healthcare, BioJamp Pharma, Eupraxia. Research support: Janssen, Abbvie, GSK, BMS, Amgen, Genentech, Merck. Stock Options: Qu Biologic.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Real-world evidence of Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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