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. 2025 Apr 30;25(1):323.
doi: 10.1186/s12876-025-03913-z.

Vedolizumab-steroid combination therapy improves long-term prognosis in patients with ulcerative colitis

Yosuke Yamada  1   2 , Natsuki Ishida  3 , Tomohiro Takebe  2 , Kenichi Takahashi  2 , Yusuke Asai  2 , Satoshi Tamura  2 , Tomoharu Matsuura  4 , Ryosuke Takano  5 , Ai Matsuura  5 , Mihoko Yamade  2 , Moriya Iwaizumi  4 , Yasushi Hamaya  2 , Takanori Yamada  6 , Satoshi Osawa  6 , Yashiro Yoshizawa  1 , Yoshisuke Hosoda  1 , Yuji Ota  5 , Hiroyuki Hanai  5 , Ken Sugimoto  2
Affiliations

Vedolizumab-steroid combination therapy improves long-term prognosis in patients with ulcerative colitis

Yosuke Yamada et al. BMC Gastroenterol. .

Abstract

Background: In real-world clinical settings, the clinical efficacy of vedolizumab (VDZ) in patients with ulcerative colitis (UC) remains unclear. In this study, we aimed to evaluate the efficacy of prednisolone (PSL)-VDZ combination therapy in patients with UC.

Methods: Changes in the clinical activity index (CAI), blood test results, and the factors affecting VDZ rate and continuity were investigated. Patients who received at least 20 mg PSL within 1 week of VDZ induction were included in the VDZ + rapid PSL induction (VDZ + rPSL) group, and the remaining were assigned to the non-VDZ + rPSL group. Failure and non-failure in both groups were compared.

Results: We conducted a comparative analysis of 38 patients with UC treated with VDZ (VDZ + rPSL, n = 14; non-VDZ + rPSL, n = 24). The CAI in both groups improved significantly from week 2 to 24 compared with the pretreatment values (P < 0.01). Clinical remission and response at week 8 were significantly higher in the VDZ + rPSL group than in the non-VDZ + rPSL group (85.7% vs. 37.5%, P < 0.01 and 85.7% vs. 41.7%, P = 0.02, respectively). Kaplan-Meier analysis showed a significant difference in the failure-free rate between the two groups (log-rank test, P = 0.02). In the VDZ + rPSL group, only C-reactive protein (CRP) levels significantly improved in non-failure at week 2 (P=0.04).

Conclusions: VDZ + rPSL induction therapy is beneficial for UC treatment. CRP levels 2 weeks after VDZ induction may influence the continuation rate in the VDZ + rPSL group.

Keywords: C-reactive protein; Steroid; Ulcerative colitis; Vedolizumab.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was reviewed and approved by the Ethics Committee of the Seirei Hamamatsu General Hospital (approval number 3932). This study was conducted in accordance with the principles of Good Clinical Practice and in adherence to the Declaration of Helsinki. Informed consent was obtained through an opt-out method, and the study details were posted on the hospital website. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart. VDZ, vedolizumab; CAI, clinical activity index; PSL, prednisolone; rPSL, rapid prednisolone
Fig. 2
Fig. 2
Changes in CAI after VDZ induction. VDZ, vedolizumab; CAI, clinical activity index; rPSL, rapid prednisolone
Fig. 3
Fig. 3
Comparison of clinical remission and response at weeks 2 and 8. (A) Remission rate at week 2; (B) Response rate at week 2; (C) Remission rate at week 8; and (D) Response rate at week 8. VDZ, vedolizumab; rPSL, rapid prednisolone
Fig. 4
Fig. 4
Comparison of VDZ failure-free rates in the VDZ-rPSL and non-VDZ-rPSL groups. VDZ, vedolizumab; rPSL, rapid prednisolone
Fig. 5
Fig. 5
Comparison of changes in serum albumin (A, B), hemoglobin (C, D), and C-reactive protein (E, F) levels from week 0 to 4 between the VDZ + rPSL and non-VDZ + rPSL groups. VDZ, vedolizumab; rPSL, rapid prednisolone
Fig. 6
Fig. 6
Comparison of the serum albumin (A, B), hemoglobin (C, D), and C-reactive protein (E, F) levels between the failure and non-failure groups. VDZ, vedolizumab; rPSL, rapid prednisolone
See this image and copyright information in PMC

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