1. 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.
- Author
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Reinglas, Jason, Gonczi, Lorant, Verdon, Christine, Bessissow, Talat, Afif, Waqqas, Wild, Gary, Seidman, Ernest, Bitton, Alain, and Lakatos, Peter L.
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THERAPEUTIC use of monoclonal antibodies , *ULCERATIVE colitis , *CROHN'S disease , *INFLAMMATORY bowel diseases , *SPECIALTY hospitals , *JOINT pain , *RETROSPECTIVE studies , *SEVERITY of illness index , *TREATMENT effectiveness , *DRUGS , *DOSE-effect relationship in pharmacology , *PATIENT compliance , *GASTROINTESTINAL agents - Abstract
Background: 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.Aims: The aim of this study is to present clinical experience with VDZ from a tertiary IBD center.Methods: 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.Results: 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.Conclusion: 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. [ABSTRACT FROM AUTHOR]- Published
- 2020
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