Early onset steroid-dependent ulcerative colitis is a predictor of azathioprine response: a longitudinal 12-month follow-up study.
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.
Chebli
Liliana Andrade
LA
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
Felga
Guilherme Goncalves Eduardo
GG
Chaves
Leonardo Duque de Miranda
LD
Pimentel
Felipe Ferreira
FF
Guerra
Dolores Martins
DM
Gaburri
Pedro Duarte
PD
Zanini
Alexandre
A
Chebli
Julio Maria Fonseca
JM
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
D000305:Adrenal Cortex Hormones; D001379:Azathioprine