title: The Value of Vedolizumab as Rescue Therapy in Moderate-Severe Crohn's Disease Patients with Adalimumab Non-response in the USA.
abstract: OBJECTIVE
  In May 2014, vedolizumab was approved by the Food and Drug Administration for the treatment of moderate-to-severe Crohn's disease. In clinical practice it is typically used in patients who are primary or secondary non-responders to adalimumab [Humira]. We aim to estimate the incremental benefits and costs of using vedolizumab as rescue therapy for adalimumab non-responders.
  
  
  METHODS
  A Markov model was used to simulate the clinical course of Crohn's disease in a hypothetical cohort of 10,000 patients over a 12-month period. The treatment strategies evaluated were adalimumab only [with and without dose intensification] and adalimumab and vedolizumab [with and without adalimumab dose intensification]. The base case strategy was adalimumab only with 25% of non-responders undergoing dose intensification. Our primary outcomes were changes in costs and quality of life measures over the analytical horizon.
  
  
  RESULTS
  In a 1-year period, initiating vedolizumab as rescue therapy in adalimumab non-responders reduces the average total cost per patient by 10%, and increases the average amount of time spent in remission or mild disease by up to 2 months.
  
  
  CONCLUSIONS
  Treating on-label adalimumab non-responders with vedolizumab can, in the short term, significantly improves the quality of life of Crohn's disease patients that do not respond to adalimumab.
authors.affiliation: Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, USA erim.daniel@unc.edu.
authors.forename: Daniel O
authors.initials: DO
authors.lastname: Erim
authors.affiliation: Department of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Nirosha
authors.initials: N
authors.lastname: Mahendraratnam
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Phillip N
authors.initials: PN
authors.lastname: Okafor
authors.affiliation: Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Stephanie B
authors.initials: SB
authors.lastname: Wheeler
mesh_terms: D000068879:Adalimumab / Q000191:economics / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000191:economics / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics / Q000627:therapeutic use*; D003198:Computer Simulation; D003424:Crohn Disease / Q000188:drug therapy* / Q000191:economics; D004334:Drug Administration Schedule; D016527:Drug Costs / Q000706:statistics & numerical data*; D004359:Drug Therapy, Combination; D006801:Humans; D008390:Markov Chains; D008954:Models, Biological; D018803:Models, Economic; D015233:Models, Statistical; D011788:Quality of Life; D012720:Severity of Illness Index; D017211:Treatment Failure; D016896:Treatment Outcome; D014481:United States
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; C543529:vedolizumab; D000068879:Adalimumab
keywords: CEA; Crohns; Vedolizumab