title: Early onset steroid-dependent ulcerative colitis is a predictor of azathioprine response: a longitudinal 12-month follow-up study.
abstract: BACKGROUND
  Studies assessing the efficacy of azathioprine (AZA) in steroid-dependent ulcerative colitis (UC) are scarce. The aim of this study was to assess the long-term efficacy and safety of AZA in patients with steroid-dependent UC, as well as factors associated with sustained response.
  
  
  METHODS
  In this prospective observational study 46 adult subjects with steroid-dependent UC were included for AZA therapy during a 12-month period. AZA dosage was adjusted according to clinical response and occurrence of adverse events. Steroid therapy was tapered according to protocol. The primary endpoint was the rate of steroid-free remission to AZA at the end of 12 months. Secondary endpoints included clinical relapse, cumulative steroid dose and safety of treatment.
  
  
  RESULTS
  On an intention-to-treat basis, the proportion of patients remaining in steroid-free remission at the end of 12 months was 0.54. The median time until complete steroid withdrawal was 5 months. A significant decrease in the relapse rate and in requirement for steroids were observed during 12 months on AZA compared with the prior year (P=0.000). Demographic, dose of AZA, steroid use, and disease-related data did not correlate with remission. Only disease duration <24 months was associated to steroid-free remission (P=0.03, OR 3.60 95% CI 1.95-9.74). Serious adverse events related to AZA were uncommon.
  
  
  CONCLUSIONS
  AZA demonstrated sustained efficacy for maintenance of clinical remission without steroids and steroid sparing through 12 months of therapy in steroid-dependent UC. Patients with early onset UC are those who most probably will achieve sustained steroid-free remission while on AZA.
authors.affiliation: Department of Medicine, Division of Gastroenterology, Inflammatory Bowel Diseases Center, University Hospital of the Federal University of Juiz de Fora, School of Medicine of the Federal University of Juiz de Fora, Minas Gerais, Brazil. chebli@globo.com
authors.forename: Liliana Andrade
authors.initials: LA
authors.lastname: Chebli
authors.forename: Guilherme Goncalves Eduardo
authors.initials: GG
authors.lastname: Felga
authors.forename: Leonardo Duque de Miranda
authors.initials: LD
authors.lastname: Chaves
authors.forename: Felipe Ferreira
authors.initials: FF
authors.lastname: Pimentel
authors.forename: Dolores Martins
authors.initials: DM
authors.lastname: Guerra
authors.forename: Pedro Duarte
authors.initials: PD
authors.lastname: Gaburri
authors.forename: Alexandre
authors.initials: A
authors.lastname: Zanini
authors.forename: Julio Maria Fonseca
authors.initials: JM
authors.lastname: Chebli
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D017668:Age of Onset; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000453:epidemiology*; D003710:Demography; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D001379:Azathioprine