Background: Corticosteroid therapy for ulcerative colitis (UC) frequently results in Steroid-dependency. The objective of this study was to evaluate the long term clinical and endoscopic efficacy of infliximab (IFX) in steroid-dependent UC.
Methods: An open-label, prospective, single center study was designed. Patients older than 18 years with steroid-dependent UC, either intolerant or did not respond to azathioprine, were consecutively enrolled. Steroid-dependency was defined as the ECCO criteria. Patients received IFX (5 mg/kg) at 0, 2 and 6 weeks and every 8 weeks thereafter for 2 years. All patients were clinically evaluated at weeks 8, 52 and 104 and a colonoscopy was performed at week 104. Response to IFX was defined as clinical remission without steroids together with mucosal healing (endoscopic Mayo score of 0 or 1).
Results: Seventeen consecutive patients were included (11 male, mean age 45, range 25-70). Thirteen (76%) had extensive colitis (E3). All patients completed IFX therapy. Clinical response was in 13/17 at weeks 8 and 52. Twelve out of seventeen patients maintained clinical remission without steroids and endoscopic response at week 104. Six out of seventeen patients needed dose intensification of IFX (every 6 weeks); 3/6 patients did not reach remission despite dose intensification. Including those patients who needed dose intensification as non-responders, 9/17 patients were in clinical and endoscopic remission at week 104. A significant correlation was found between clinical and endoscopic findings (p<0.01).
Conclusions: Infliximab therapy is effective for maintenance of clinical remission and mucosal healing in patients with steroid-dependent UC.