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Aim: Third-level Day-Hospital Services of Gastro-Hepatology are likely to recruit patients with an increased disease severity. The burden of request for immunomodulation drugs is presently unclear., Methods: The charts of 1 012 consecutive patients who underwent day-hospital admission were reviewed. Among them, 975 were admitted for several reasons (percutaneous liver biopsies, abdominal fluid aspirations, infiltrations of hepatic nodules, gastrointestinal endoscopies with specific treatments). Data of the remaining 37 patients were elaborated., Results: Of them, 31 (83%) suffered from ulcerative colitis (UC) or Crohn's disease (CD) (17 and 14, respectively) and 6 from autoimmune type 1 hepatitis (AIH). Of the 14 non-operated UC patients, 12 were taking azathioprine (AZA) and 2 infliximab (IFX). Among CD patients, the majority received AZA (N=6) or IFX (N=6). Of the AIH patients, 5 were treated with AZA and 2 had also cyclosporine. Overall, corticosteroids (32%) and IFX (21%) ranked first and second among the induction drugs, and AZA ranked first (62%) as maintenance option. Of the 4 CD patients under IFX treatment, 2 were switched to leukapheresis for incomplete response, the third one developed thrombotic complications, and the last one achieved disease remission after 12 months. Of the 2 cases of UC, one lost response soon and was colectomized, the other is maintaining moderately active disease, requiring scheduled injections every 8 weeks., Conclusion: Despite the caution imposed by the very small numbers, this analysis confirms that the potent available options are difficult to be correctly positioned in the therapeutic algorithm of inflammatory bowel disease.

The monoclonal antibody to the tumour necrosis factor--infliximab--has recently been added to the list of off-label therapeutic means for ulcerative colitis. We conducted a descriptive analysis of the results from studies on the use of the drug published so far. A total of 187 patients qualified for analysis. They were divided into four main categories, including steroid-refractory and responsive adults and children. The median frequencies of an early and a sustained response were 77 and 44.5%. These data suggest that adult non-steroid-refractory, and paediatric patients may respond with the highest frequency. While it is obligatory to wait for the yield of the ongoing controlled trials before any conclusion on these indications is drawn, the data provide seminal ideas to further investigations, including the hypothesis to inaugurate with infliximab a top-down strategy for the treatment of inflammatory bowel disease.

Background: Success achieved in two subtypes of Crohn's disease has persuaded a few investigators to experiment the monoclonal anti-tumour necrosis factor antibody infliximab in the treatment of ulcerative colitis. So far, however, the results (achieved in some 30 steroid-refractory patients included in two independent full-papers) indicate a rate of initial response of 50% and of remission of 25%., Aims: To analyse data of an open trial conducted on consecutive steroid-refractory severely ill patients admitted to our referral Unit., Patients and Methods: In 9 months, infliximab was given to 8 patients (4 male, 4 female aged 20-60 years) with uncontrolled ulcerative colitis of whom 6 were non-responders to parenteral steroids. All received the first infliximab dose as an intravenous infusion of 5 mg/kg., Results: Of the 8, 4 (50%) did not respond to the first injection and were submitted to urgent colectomy; the other four responded clinically. Two have maintained clinical remission for 7 months, without the need for steroids; both have received daily azathioprine at 2 mg/kg, and only one has received two further infliximab injections. Of the other two, one received a second injection at week 5, despite this relapsed, and underwent elective colectomy at that time; the other relapsed at 6 months and showed a partial response to a repeat infliximab infusion. Thus, the rate of sustained response is 2/8 (25%) in this study., Conclusion: These results, achieved in an open uncontrolled fashion, seem to reflect those of other independent studies. In our opinion, these findings warrant an in-depth reappraisal of the indication to use infliximab as rescue treatment for refractory ulcerative colitis.