Extraintestinal Manifestations in Vedolizumab and Anti-TNF-Treated Patients With Inflammatory Bowel Disease

Inflamm Bowel Dis. 2018 Aug 16;24(9):1876-1882. doi: 10.1093/ibd/izy065.

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.

Keywords: anti–tumor necrosis therapy; inflammatory bowel disease; systemic extra-intestinal manifestations; vedolizumab.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Cholangitis, Sclerosing / epidemiology
  • Cholangitis, Sclerosing / etiology
  • Cholangitis, Sclerosing / prevention & control
  • Colitis, Ulcerative / complications*
  • Colitis, Ulcerative / drug therapy
  • Crohn Disease / complications*
  • Crohn Disease / drug therapy
  • Databases, Factual
  • Erythema Nodosum / epidemiology
  • Erythema Nodosum / etiology
  • Erythema Nodosum / prevention & control
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • 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
  • Tumor Necrosis Factor Inhibitors / therapeutic use*
  • United States / epidemiology
  • Uveitis / epidemiology
  • Uveitis / etiology
  • Uveitis / prevention & control

Substances

  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • Tumor Necrosis Factor Inhibitors
  • vedolizumab