Azathioprine therapy in steroid-dependent patients with Crohn disease: results of a 10-year longitudinal follow-up study.
BACKGROUND
Studies assessing the efficacy of azathioprine in steroid-dependent patients with Crohn's disease are scarce. The aim of this study was to assess the long-term efficacy and safety of azathioprine, and factors associated with sustained response, in steroid-dependent patients with Crohn's disease.


METHODS
In this prospective, observational study, adult steroid-dependent subjects with Crohn's disease receiving azathioprine therapy were assessed over a 10-year period. Azathioprine dosage was adjusted according to clinical response and occurrence of adverse events. Median treatment duration was 83 months. Steroid therapy was tapered according to protocol.


RESULTS
A total of 106 subjects were included. The proportion of subjects remaining in sustained steroid-free remission at 12, 24, 36, 48, and 60 months was 0.61, 0.73, 0.72, 0.70, and 0.70, respectively. Thereafter, the rate of weaning from steroids decreased gradually, reaching a nadir of 0.41 at 108 months. Median time to complete steroid withdrawal was 6 months. Demographic, azathioprine dose, and disease-related data did not correlate with remission. By multivariate analysis, only decreased mean leukocyte count during follow-up was independently associated with steroid-free remission (P=.001). Subjects who achieved an annual mean leukocyte count <6,000/mm(3) were more likely to sustain steroid-free remission (P=.01). Serious adverse events in response to azathioprine were uncommon.


CONCLUSIONS
Azathioprine therapy offers a meaningful option in the management of steroid-dependent Crohn's disease for up to 10 years. A persistent decrease in leukocyte count may provide a surrogate marker of sustained steroid-free response.
Pinto
André Luiz Tavares
AL
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.
Chebli
Liliana Andrade
LA
Ribeiro
Mario Sergio
MS
Pace
Fábio Heleno de Lima
FH
Moraes
Jussara Paixão
JP
do Amaral
Flávio José
FJ
Gaburri
Pedro Duarte
PD
Meirelles de Souza
Aécio Flávio
AF
Chebli
Julio Maria Fonseca
JM
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D011446:Prospective Studies; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D001379:Azathioprine