Azathioprine maintains long-term steroid-free remission through 3 years in patients with steroid-dependent ulcerative colitis.
BACKGROUND
Studies assessing the efficacy of azathioprine (AZA) in steroid-dependent ulcerative colitis (SD-UC) are scarce. The purpose of this trial was to explore the efficacy of AZA in maintaining steroid-free remission in SD-UC patients and the factors associated with sustained response.


METHODS
In this observational cohort study, 42 subjects with SD-UC were recruited for AZA therapy during a 3-year period. AZA was adjusted for a target dose of 2-3 mg/kg/day. Steroid therapy was tapered off following a standardized regimen. The primary endpoint was the annual rate of steroid-free response to AZA. Secondary endpoints included clinical recurrence, yearly steroid dose, and safety of treatment.


RESULTS
On an intention-to-treat basis, the proportion of patients remaining in steroid-free remission at 12, 24, and 36 months was 0.55, 0.52, and 0.45, respectively. A significant decrease in the flare-ups rate and in requirement for steroids were observed during 3 years on AZA compared with the previous year (P = 0.000 for both). Patients with and without sustained response were comparable according to demographics, extent of disease, dose of AZA, steroids, and 5-aminosalicylate (5-ASA) use. Only disease duration <36 months was associated with off-steroids remission (P = 0.02, odds ratio [OR] 3.12, 95% confidence interval [CI] 1.89-7.64). The AZA benefit-risk profile was favorable.


CONCLUSIONS
In this open-label observational trial AZA showed sustained efficacy for maintenance of clinical remission off steroids and steroid sparing through 3 years of therapy in SD-UC. Patients with earlier UC are those who most probably will have sustained steroid-free remission at the end of 12 months while on AZA.
Chebli
Liliana Andrade
LA
Division of Gastroenterology, Department of Medicine, Inflammatory Bowel Diseases Center, University Hospital of the Federal University of Juiz de Fora, University of Juiz de Fora School of Medicine, Minas Gerais, Brazil.
Chaves
Leonardo Duque de Miranda
LD
Pimentel
Felipe Ferreira
FF
Guerra
Dolores Martins
DM
Barros
Renata Maria de Freitas
RM
Gaburri
Pedro Duarte
PD
Zanini
Alexandre
A
Chebli
Julio Maria Fonseca
JM
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000494:pharmacology*; D000328:Adult; D001379:Azathioprine / Q000627:therapeutic use*; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D001379:Azathioprine