Evaluating clinical data on the safety and efficacy of vedolizumab (VDZ) in ‘real-world’ setting is still desirable. Recent reports have raised concerns that arthralgia may be associated with VDZ.
The aim of this study is to present clinical experience with VDZ from a tertiary IBD center.
Retrospective chart reviews were performed of consecutive patients exposed to VDZ between 2015 and 2018. Clinical, biomarker, and endoscopic efficacy and safety data were evaluated.
A total of 130 IBD (75CD, 55UC) patients were included. Median duration of VDZ therapy was 65 weeks. Probability of drug discontinuation was 4.9% and 9.4% at 1 and 2 years. Dose intensification was more frequent in CD compared to UC (at 1 and 2 years: 64.8/87.9% vs. 26.5/35.7%, p < 0.001). Clinical remission rates at 3-, 6- and 12 months were 44.4%, 71.4% and 77.1% in UC, and 9.1%, 26.7% and 29.2% in CD patients, respectively. Prior use of multiple biologic agents was associated with diminished efficacy of VDZ in CD. Three new cases of arthralgia were encountered during follow-up.
Vedolizumab (VDZ) therapy displayed good drug sustainability and clinical efficacy in a population with severe disease phenotype and high rates of previous anti-TNF failure. Frequent dose intensification was required. The safety profile was good, and no association between newly onset arthralgia and VDZ therapy was observed.
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JR and LG were responsible for data analysis, literature overview and drafting the manuscript. CV, TB, WA, GW, ES, and AB contributed to the data collection and the final analysis and conducted critical review of the manuscript. PLL was leader of research planning and result interpretation; also he contributed to the statistical planning and data analysis, supervised the manuscript preparation, and is acting as guarantor of submission. All authors read and approved the final manuscript including the authorship list.
Conflict of interest
JR, LG, and CV declare no conflict of interest. GW has been a speaker and/or advisory board member for AbbVie, Janssen, Pfizer, Shire, and Takeda. ES has received unrestricted research grants from AbbVie and Janssen. AB has been a member of Advisory Boards—Abbvie, Pfizer, Takeda, Janssen, Merck; Speaker’s bureau—Abbvie, Janssen, Takeda, Pfizer. TB has been a peaker or advisory board member for Takeda, Janssen, Abbvie, Merck, Pfizer, Pendopharm, Ferring, Shire. WA has been a speaker for Janssen, Prometheus, Dynacare, Takeda, AbbVie Theradiag. PLL has been a speaker and/or advisory board member for AbbVie, Falk Pharma GmbH, Ferring, Genetech, Janssen, Kyowa Hakko Kirin Pharma, Mitsubishi Tanabe Pharma Corporation, MSD, Pfizer, Roche, Shire, and Takeda and has received unrestricted research grants from AbbVie, MSD, and Pfizer.
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Reinglas, J., Gonczi, L., Verdon, C. et al. Low Rate of Drug Discontinuation, Frequent Need for Dose Adjustment, and No Association with Development of New Arthralgia in Patients Treated with Vedolizumab: Results from a Tertiary Referral IBD Center. Dig Dis Sci 65, 2046–2053 (2020). https://doi.org/10.1007/s10620-019-05982-z
- Crohn’s disease
- Ulcerative colitis