Infliximab in severe steroid-refractory ulcerative colitis: a pilot study

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• Tumor necrosis factor-alpha (TNF-alpha) neutralization with infliximab is effective for Crohn's disease (CD).
• Severe active ulcerative colitis (UC) refractory to steroids presents a therapeutic challenge.

Purpose of the Study:

• To evaluate the efficacy and safety of a single infliximab infusion in patients with severe, steroid-refractory UC.
• To assess clinical and endoscopic outcomes following infliximab treatment.

Main Methods:

• An open-label pilot study involving six patients with severe active, steroid-refractory UC.
• Single 5 mg/kg infliximab infusion administered.
• Clinical activity assessed using the Lichtiger score at baseline, day 7, and day 28.
• Colonoscopy with biopsies performed at baseline and day 7.
• Histopathological analysis included H&E staining and immunohistochemistry.

Main Results:

• All patients demonstrated significant clinical improvement by day 7 (Lichtiger score reduction: p < 0.0001).
• Four out of six patients achieved long-term remission by day 28 (p < 0.01 vs baseline).
• Colonoscopy revealed substantial healing of endoscopic lesions and reduced mucosal inflammatory infiltrates.
• Apoptotic cells in the mucosa were decreased by day 7.

Conclusions:

• A single infliximab infusion shows promise as an efficacious treatment for severe steroid-refractory ulcerative colitis.
• The findings support infliximab as a potential novel therapeutic option for UC.
• Further controlled trials are necessary to confirm these results and establish optimal treatment protocols.