IV Immunosuppressant Superior to Oral Therapy in Patients with Steroid-Dependent Ulcerative Colitis

In an investigator-blinded study ?published in Gut (2006;55:47-53), significantly more steroid-dependent ulcerative colitis patients who received intravenous (IV) azathioprine demonstrated clinical and endoscopic ?re?mission and were able to discontinue steroid therapy compared with patients taking the oral 5-aminosalicylic acid (5-ASA).

Included were 72 patients (27 men; mean age, 44 years) with steroid-dependent ulcerative colitis. Steroid dependence was defined as requiring Ž10 mg/day of steroid therapy during the previous 6 months, with at least 2 attempts at stopping it. All the patients were receiving systemic prednisone (Meticorten; 40 mg/d). Ulcerative colitis had to be clinically and endoscopically active at study entrance. Participants were randomized to either IV azathioprine (2 mg/kg daily) or oral 5-ASA (3.2 g/d) for a period of 6 months.

The primary outcome was clinical success, defined as initiation of clinical and endoscopic re?mission and steroid discontinuation; or failure, defined as a lack of clinical and endoscopic remission and continued steroid use, or colectomy.

Successful clinical and endoscopic remissions were reported in 53% of the patients in the azathioprine group compared with only 19% of those in the 5-ASA group (P = .006), for an absolute risk re?duction of 34% with azathioprine.

Azathioprine-treated patients also had greater improvements in the Powell-Tuck Index of clinical features (P = .01), the Baron Index of endoscopic findings (P <.001), and Physician Global Assessment score (P = .001), compared with baseline, over the 6-month study period.

Adverse effects, however, occurred more often in patients receiving azathioprine (26%) than in those taking 5-ASA (6%), and included decreased blood counts, increased transaminase levels, fever, headache, and abdominal pain. Nevertheless, most side effects in the azathioprine group resolved when the doses were reduced.

&#8220;Azathioprine is significantly more effective than 5-aminosalicylic acid in inducing clinical and endoscopic remission and avoiding steroid requirement in the treatment of steroid-dependent ulcerative colitis,&#8221; lead investigator S. Ardizzone, of L Sacco University Hospital, Milan, Italy, and colleagues conclude.&#8212;R.M.