Efficacy and safety of thiopurinic immunomodulators (azathioprine and mercaptopurine) in steroid-dependent ulcerative colitis.

Abstract

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 Azathioprine was withdrawn in seven cases (20.6%); in four of them (with liver toxicity), treatment with mercaptopurine was indicated.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.

• Authors: A Lopez-Sanroman, F Bermejo, E Carrera, A Garcia-Plaza
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 20 Issue 2 Pg. 161-6 (Jul 15 2004) ISSN: 0269-2813 [Print] England
• PMID: 15233695 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Immunosuppressive Agents
• Mercaptopurine
• Azathioprine

Topics

• Adult
• Azathioprine (therapeutic use)
• Colitis, Ulcerative (drug therapy)
• Female
• Humans
• Immunosuppressive Agents (therapeutic use)
• Male
• Mercaptopurine (therapeutic use)
• Prospective Studies
• Treatment Outcome