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Observational Study
. 2023 Nov 29;23(1):417.
doi: 10.1186/s12876-023-03032-7.

Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn's disease in Europe: a retrospective observational study

Roni Weisshof  1 , Stephan R Vavricka  2   3 , Lieven Pouillon  4 , Fiona Braegger  5 , Montserrat Roset  6 , Nawal Bent-Ennakhil  5 , Marc Ferrante  7
Affiliations
Observational Study

Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn's disease in Europe: a retrospective observational study

Roni Weisshof et al. BMC Gastroenterol. .

Abstract

Background: Vedolizumab (VDZ), a gut-selective anti-lymphocyte trafficking integrin antibody, is effective in treating patients with moderately to severely active Crohn's disease (CD). In this study, we examined the real-world effectiveness and safety of induction therapy using VDZ alone or in combination with budesonide (VDZ + BUD) among patients with CD in Belgium, Israel, and Switzerland.

Methods: This retrospective chart review analysis included adult patients with moderately to severely active CD who started induction treatment with VDZ or VDZ + BUD (January 2015 through January 2019). The primary objective of this study was to assess the effectiveness in terms of clinical remission of VDZ alone or VDZ + BUD using patient-reported outcomes (PRO) of abdominal pain (AP) and/or loose stool frequency (LSF) (PRO-2) at weeks 0, 2, 6, 10, and 14. Regression models were used to assess differences and associations between the treatment groups.

Results: Overall, 123 patients were included (VDZ, n = 73; VDZ + BUD, n = 50). Clinical remission rates at week 14 were 71.4% (50/70) and 68.0% (34/50) with VDZ and VDZ + BUD, respectively. Mean percentage change in AP and LSF from baseline to week 14 was comparable between the groups. Median (95% confidence interval [CI]) time to clinical remission was 91 [70.0-98.0] and 95 [70.0-98.0] days, respectively. One patient in each group discontinued VDZ and 68.0% of patients in the VDZ + BUD group discontinued BUD before week 14. The rates of overall adverse events were similar between the groups (VDZ, 23.3%; VDZ + BUD, 26.0%).

Conclusions: In this retrospective study, VDZ alone and VDZ + BUD showed similar high remission rates in patients with moderately to severely active CD. Prospective randomized studies are needed to conclude on the role of combining VDZ with BUD.

Trial registration: Not applicable.

Keywords: Budesonide; Crohn’s disease; Moderately to severely active crohn’s disease; Vedolizumab.

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Conflict of interest statement

RW has received advisory board fees from Janssen and AMAG Pharmaceuticals and presentation fees from Takeda, AbbVie, and Janssen. SRV has received consulting fees, unrestricted research grants, and speaker fees from Abbott, Celltrion, Ferring, MSD, Pfizer, Sanofi-Aventis, Takeda, Tillotts, UCB, Vifor, and Falk Pharma. LP has received advisory board fees from Galápagos, Janssen-Cilag, Sandoz, and Takeda; presentation fees from AbbVie, Celltrion, Ferring, and Galápagos; grant support from Takeda; and personal fees (congress support) from AbbVie, Ferring, Norgine, and Takeda. FB was an employee of Takeda and held Takeda stock options at the time the study was conducted. MR is an employee of IQVIA. NB-E is an employee of Takeda and owns stock. MF has received research grants from AbbVie, Amgen, Biogen, Janssen, Pfizer, Takeda, and Viatris; consultancy fees from AbbVie, Boehringer Ingelheim, Celltrion, Janssen, Eli Lilly, Medtronic, MSD, Pfizer, Sandoz, Takeda, Thermo Fisher, and Viatris and speaker fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Falk, Ferring, Janssen, Lamepro, MSD, Mylan, Pfizer, Sandoz, Takeda, Truvion Healthcare, and Viatris.

Figures

Fig. 1
Fig. 1
Study design. VDZ = vedolizumab; BUD = budesonide
Fig. 2
Fig. 2
Clinical remission rates at week 14. VDZ = vedolizumab; BUD = budesonide
Fig. 3
Fig. 3
Mean percentage change in APS and LSF from baseline. APS = abdominal pain score; BUD = budesonide; LSF = loose stool frequency; VDZ = vedolizumab
Fig. 4
Fig. 4
Time to clinical remission (days) according to patient-reported symptoms: APS (≤ 1) and LSF (≤ 3). PRO-2 is estimated as a sum of the weighted averages of APS and LSF. APS = abdominal pain score; BUD = budesonide; CI = confidence interval; LSF = loose stool frequency; VDZ = vedolizumab
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