Early onset steroid-dependent ulcerative colitis is a predictor of azathioprine response: a longitudinal 12-month follow-up study
Liliana Andrade Chebli, Guilherme Goncalves Felga, Leonardo Duque Miranda Chaves, Felipe Ferreira Pimentel, Dolores Martins Guerra, Pedro Duarte Gaburri, Alexandre Zanini, Julio Maria Chebli
Med Sci Monit 2010; 16(2): PI1-6
Available online: 2010-02-01
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.
Material and Method: 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.
Keywords: Time Factors, Longitudinal Studies, Follow-Up Studies, Dose-Response Relationship, Drug, Demography, Colitis, Ulcerative - epidemiology, Azathioprine - therapeutic use, Age of Onset, Adult, Adrenal Cortex Hormones - therapeutic use, Adolescent, young adult