Efficacy and safety of thiopurinic immunomodulators (azathioprine and mercaptopurine) in steroid-dependent ulcerative colitis
Article first published online: 25 JUN 2004
Alimentary Pharmacology & Therapeutics
Volume 20, Issue 2, pages 161–166, July 2004
How to Cite
Lopez-Sanroman, A., Bermejo, F., Carrera, E. and Garcia-Plaza, A. (2004), Efficacy and safety of thiopurinic immunomodulators (azathioprine and mercaptopurine) in steroid-dependent ulcerative colitis. Alimentary Pharmacology & Therapeutics, 20: 161–166. doi: 10.1111/j.1365-2036.2004.02030.x
- Issue published online: 25 JUN 2004
- Article first published online: 25 JUN 2004
- Accepted for publication 7 May 2004
Background : The efficacy of azathioprine in the management of steroid-dependent ulcerative colitis is taken for granted. However, study populations frequently include together steroid-dependent and refractory patients.
Aim : To assess the efficacy and safety of thiopurinic immunomodulators in strictly defined steroid-dependent ulcerative colitis.
Methods : Survey of 34 patients with steroid-dependent ulcerative colitis, treated with azathioprine according to protocol. Therapeutical success: glucocorticoid withdrawal within 12 months, without steroid requirements during another year.
Results : Mean age was 39.1 ± 17 years. Pancolitis and extensive colitis accounted for 50% of cases. Therapeutic success of immunomodulator treatment reached 70.6%, intention to treat analysis (confidence interval 95%: 52–84%) and 72.7%, as per protocol (confidence interval 95%: 54–86%). Mean time to steroid withdrawal was 4.6 months. In therapy successes, mean corpuscular volume and total serum bilirubin increased with treatment time (P = 0.0001). Fifteen adverse effects were observed in 13 patients (38%). Azathioprine was withdrawn in seven cases (20.6%); in four of them (with liver toxicity), treatment with mercaptopurine was indicated.
Conclusions : Therapy with thiopurinic immunomodulators (azathioprine) represents the first option in the management of steroid-dependent ulcerative colitis. Its efficacy (70%) and its acceptable safety support this view. Increasing mean corpuscular volume and serum bilirubin values may be a surrogate marker of a beneficial effect.