title: Treatment patterns, complications, and disease relapse in a real-world population of patients with moderate-to-severe ulcerative colitis initiating immunomodulator therapy.
abstract: BACKGROUND
  Immunomodulator (IM) treatments in ulcerative colitis (UC) are not curative and carry increased risk of complications, sometimes leading to therapy changes, reduced treatment benefits, and eventual relapse. We assessed patterns of IM utilization and therapy changes, complications, and disease relapse in a real-world population of patients with moderate-to-severe UC.
  
  
  METHODS
  Claims data from a large commercially insured U.S. population were retrospectively analyzed. Inclusion criteria were (1) ≥2 UC diagnosis claims (ICD-9-CM 556.xx) between January 2005 and July 2010, (2) ≥1 IM claim, where first IM claim defined the index date, (3) ≥12 months preindex health plan enrollment (baseline), and (4) ≥24 months postindex plan enrollment (follow-up). Characteristics of and changes to the index IM therapy during follow-up were descriptively assessed, as were complications and disease relapses.
  
  
  RESULTS
  A total of 2136 patients were identified for inclusion (age, mean [SD], 46 [16] years, 54% female). Azathioprine was the most common index IM (46% of patients), followed by 6-mercaptopurine (28%). Switching from the index IM to another therapy class was common (21% of patients), with 5-ASAs (48% of switchers), oral corticosteroids (21%), and biologics (17%) being the most frequent next agents used. Augmentation was also common (25% of patients), with 5-ASA being, by far, the most frequent agent added to the index IM (72% of augmenters). Thirty percent of patients experienced a complication, and 73% of patients relapsed, with the majority of relapses occurring during index IM exposure.
  
  
  CONCLUSIONS
  This assessment of IM treatments for UC demonstrated frequent changes to therapy and high downstream complication and relapse rates.
authors.affiliation: *Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnestota; †Health Economics, RTI Health Solutions, Research Triangle Park, North Carolina; and ‡Global Health Economics and Outcomes Research, Bristol Myers Squibb Company, Princeton, New Jersy.
authors.forename: Edward V
authors.initials: EV
authors.lastname: Loftus
authors.forename: Keith L
authors.initials: KL
authors.lastname: Davis
authors.forename: Chi-Chuan
authors.initials: CC
authors.lastname: Wang
authors.forename: Homa
authors.initials: H
authors.lastname: Dastani
authors.forename: Allison
authors.initials: A
authors.lastname: Luo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects*; D007249:Inflammation / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012008:Recurrence; D012189:Retrospective Studies; D012307:Risk Factors; D055815:Young Adult
chemical_list: D007155:Immunologic Factors