1. Extraintestinal Manifestations in Vedolizumab and Anti-TNF-Treated Patients With Inflammatory Bowel Disease.
- Author
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Dubinsky MC, Cross RK, Sandborn WJ, Long M, Song X, Shi N, Ding Y, Eichner S, Pappalardo B, Ganguli A, and Wang A
- Subjects
- Adult, Cholangitis, Sclerosing epidemiology, Cholangitis, Sclerosing etiology, Cholangitis, Sclerosing prevention & control, Colitis, Ulcerative drug therapy, Crohn Disease drug therapy, Databases, Factual, Erythema Nodosum epidemiology, Erythema Nodosum etiology, Erythema Nodosum prevention & control, Female, Humans, Incidence, Joint Diseases epidemiology, Joint Diseases etiology, Joint Diseases prevention & control, Male, Middle Aged, Pyoderma Gangrenosum epidemiology, Pyoderma Gangrenosum etiology, Pyoderma Gangrenosum prevention & control, Scleritis epidemiology, Scleritis etiology, Scleritis prevention & control, Stomatitis, Aphthous epidemiology, Stomatitis, Aphthous etiology, Stomatitis, Aphthous prevention & control, Treatment Outcome, United States epidemiology, Uveitis epidemiology, Uveitis etiology, Uveitis prevention & control, Antibodies, Monoclonal, Humanized therapeutic use, Colitis, Ulcerative complications, Crohn Disease complications, Gastrointestinal Agents therapeutic use, Tumor Necrosis Factor Inhibitors therapeutic use
- Abstract
Background: Extra-intestinal manifestations (EIMs) can impact morbidity in patients with inflammatory bowel diseases (IBD; Crohn's disease [CD] and ulcerative colitis [UC]). This study compared incidence rates of EIMs in patients with moderate to severe IBD receiving gut-selective vedolizumab (VDZ) vs those receiving systemic anti-tumor necrosis factor (anti-TNF) therapies., Methods: Adult IBD patients receiving VDZ or anti-TNFs were identified from the MarketScan claims database from September 28, 2012, through September 30, 2016. Incidence rates of EIMs were compared between the 2 cohorts. Descriptive analyses were performed for all courses of treatment. Generalized linear models estimated the impact of treatment on the likelihood of developing EIMs., Results: Compared with patients receiving anti-TNF therapy, VDZ-treated CD patients were 28% more likely to develop "any EIMs" (adjusted incident rate ratio [IRR], 1.28; 95% confidence interval [CI], 1.02-1.62). Specifically, CD patients treated with VDZ were more likely to develop erythema nodosum (IRR, 4.29; 95% CI, 1.73-10.64), aphthous stomatitis (IRR, 3.73; 95% CI, 1.51-9.23), episcleritis/scleritis (IRR, 2.51; 95% CI, 1.02-6.14), arthropathy (IRR, 1.45; 95% CI, 1.15-1.84), primary sclerosing cholangitis (PSC) (IRR, 7.79; 95% CI, 3.32-18.27), and uveitis/iritis (IRR, 2.89; 95% CI, 1.35-6.18). UC patients receiving VDZ did not have a statistically significant increase in "any EIMs" vs patients receiving anti-TNFs, but were more likely to develop specific EIMs (aphthous stomatitis: IRR, 3.67; 95% CI, 1.30-10.34; pyoderma gangrenosum: IRR, 4.42; 95% CI, 1.00-19.45; and PSC: IRR, 3.44; 95% CI, 1.23-9.68)., Conclusions: IBD patients receiving VDZ may be more likely to develop EIMs vs patients receiving anti-TNF therapies. The gut-selective inflammatory control of VDZ may potentially limit its clinical effect on EIM prevention., (© 2018 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2018
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