Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn’s disease: results from an Italian multicenter study

ABSTRACT

Background

Vedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn’s disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ.

Research design and methods

 Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.

Results

729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6^th month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6^th month of treatment (p=0.001) and being naïve to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016).

Conclusion

We found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug’s longterm efficacy.

KEYWORDS:

• Crohn’s disease
• ulcerative colitis
• vedolizumab
• remission
• safety

Declaration of interest

G Maconi has served as speaker and/or has received advisory board fees for AlfaSigma, Arena, Janssen, Gilead and Roche. D Pugliese has received speaker fees from AbbVie, MSD, Takeda, Janssen and Pfizer. F Scaldaferri has served as lecturer for Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Ethics statement

The authors state that they conducted the study according to clinical practice guidelines and the principles of the Declaration of Helsinki. All patients gave written informed consent before undergoing endoscopy and VDZ treatment. According to Italian law, retrospective studies do not need patients’ consent to use their anonymized data for medical research, nor specific permission from Ethics Committees for sharing patient’s databases except for simple communication of the study beginning. However, Ethics Committee approval for this retrospective study was obtained from ‘Brotzu’ Hospital (Cagliari, Italy, PROT. PG/2022/6364), the reference center for this study. The anonymized dataset was provided by and utilized with permission from A Tursi.

Author contributions

Conception and design: G Mocci, A Tursi, A Papa.

Acquisition and collection of data: All authors.

Analysis and interpretation of data: A Tursi, W Elisei, M Picchio, G Maconi, A Papa.

Drafting of the paper or revising it critically for intellectual content: A Tursi, G Maconi, E Savarino, W Elisei, G Bassotti, M Picchio, A Papa.

Final approval of the version to be published: All authors.

Additional information

Funding

This paper was not funded.