Gastroenterology

Gastroenterology

Volume 120, Issue 6, May 2001, Pages 1323-1329
Gastroenterology

Alimentary Tract
Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis

https://doi.org/10.1053/gast.2001.23983Get rights and content

Abstract

Background & Aims: Cyclosporine has been effective in patients with steroid-refractory attacks of ulcerative colitis (UC). We investigated the effects of intravenous (IV) cyclosporine as single IV therapy (without glucocorticosteroids) for severe UC and compared these with the response to glucocorticosteroids. Methods: Patients with a severe attack of UC were randomized to treatment with IV cyclosporine, 4 mg · kg−1 · day−1, or with methylprednisolone, 40 mg/day, in a randomized, double-blind, controlled trial. After 8 days, patients who had a response received the same medication orally in combination with azathioprine. Patients were followed up clinically, endoscopically, and by scintigraphy. Renal function was assessed using urinary inulin clearances. Endpoints were clinical improvement, discharge from the hospital, and remission up to 12 months after intravenous therapy. Results: Thirty patients were included. After 8 days, 8 of 15 patients (53%) who received methylprednisolone had a response to therapy vs. 9 of 14 (64%) receiving cyclosporine. In nonresponders, 3 of 7 methylprednisolone patients and 1 of 3 cyclosporine patients improved when both treatments were combined. No serious drug-related toxicity was observed with either treatment. At 12 months, 7 of 9 patients (78%) initially controlled with cyclosporine maintained their remission vs. 3 of 8 (37%) initially treated with methylprednisolone. No clinically significant decrease of renal function was observed. Conclusions: Cyclosporine monotherapy is an effective and safe alternative to glucocorticosteroids in patients with severe attacks of UC.

GASTROENTEROLOGY 2001;120:1323-1329

Section snippets

Patient selection and eligibility

This single-center prospective, double-blind, controlled randomized trial compared the efficacy of IV glucocorticosteroids with that of cyclosporine, both given as single IV therapy in continuous infusion for 8 days. Patients were between the ages of 18 and 70 years and were hospitalized with a severe attack of UC. All patients had undergone colonoscopy showing UC extending at least to the splenic flexure at an earlier stage. On the day of inclusion or on the day before, a flexible

Patient characteristics and response to treatment

From January 1997 to July 1998, 30 sequential patients presenting at the emergency room and the outpatient clinic who met the inclusion criteria were asked to take part in this trial; none refused to do so. Fifteen patients were treated with methylprednisolone and 15 with cyclosporine in random order. Patient characteristics are shown in Table 2.

. Baseline characteristics of 30 patients with severe UC

CharacteristicCyclosporine groupMethylprednisolone groupP
n1515
Mean age, yr (range)36.7 ± 2.8

Discussion

In this trial we found that IV cyclosporine was at least as effective as IV glucocorticosteroids for severe attacks of UC. The mean time to response with cyclosporine was comparable to that observed in other trials, in which cyclosporine was administered in combination with glucocorticosteroids and in which even longer treatments (up to 14 days) were given.7, 9 Clinical improvement after 8 days was not always accompanied by an endoscopic and histologic response. Mucosal healing and

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  • Cited by (0)

    Address requests for reprints to: Geert R. D'Haens, M.D., Ph.D., Department of Internal Medicine, University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. e-mail: [email protected]; fax: (32) 16-34-42-99.

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