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Azathioprine or methotrexate in the treatment of patients with steroid-dependent or steroid-resistant ulcerative colitis: results of an open-label study on efficacy and tolerability in inducing and maintaining remission.

AbstractBACKGROUND: The role of azathioprine and methotrexate in inducing and maintaining remission in patients with ulcerative colitis is still controversial. AIM: To evaluate the efficacy and tolerability of these two drugs in a series of patients with steroid-dependent or steroid-resistant active ulcerative colitis. METHODS: Forty-two patients were treated with a daily dose of azathioprine (2 mg/kg) and, if intolerant or not responding, with methotrexate (12.5 mg/week intramuscularly), and their efficacy was established by clinical, endoscopic and histological examinations at 6 months. Patients achieving clinical remission continued with treatment and were followed up. RESULTS: Of the 42 patients on azathioprine, 10 experienced early side-effects requiring withdrawal from treatment, 22 (69%) achieved complete remission, six (19%) achieved improvement and four (12%) obtained no substantial benefit. Methotrexate, administered to eight patients intolerant to and two patients resistant to azathioprine, induced complete remission in six patients (60%) and improvement in four (40%). During follow-up, a larger number of patients on azathioprine relapsed in comparison with patients on methotrexate [16/28 (57%) vs. 2/10 (20%), respectively; P < 0.05]. Only minor side-effects were observed on both treatments. CONCLUSIONS: Azathioprine is effective in patients with steroid-dependent or steroid-resistant ulcerative colitis. Methotrexate seems to be a good alternative in patients intolerant to or not responding to azathioprine.
AuthorsO A Paoluzi, R Pica, A Marcheggiano, P Crispino, F Iacopini, C Iannoni, M Rivera, P Paoluzi (Affiliation: Department of Clinical Sciences, Gastroenterology Unit, La Sapienza University, Rome, Italy. paolo.paoluzi at uniroma1.it)
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 16 Issue 10 Pg. 1751-9 (Oct 2002) ISSN: 0269-2813 England
PMID12269968 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents
  • Immunosuppressive Agents
  • Azathioprine
  • Prednisone
  • Methotrexate
Topics
  • Adult
  • Aged
  • Anti-Inflammatory Agents (therapeutic use)
  • Azathioprine (adverse effects, therapeutic use)
  • Colitis, Ulcerative (drug therapy, pathology)
  • Drug Administration Schedule
  • Drug Resistance
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents (adverse effects, therapeutic use)
  • Male
  • Methotrexate (adverse effects, therapeutic use)
  • Middle Aged
  • Prednisone (therapeutic use)
  • Remission Induction
  • Single-Blind Method
  • Treatment Outcome