Infliximab in severe ulcerative colitis: short‐term results of different infusion regimens and long‐term follow‐up

Abstract

SUMMARY BackgroundSevere ulcerative colitis is a life-threatening disorder, despite i.v. glucocorticoids treatment. Infliximab has been proposed as a safe rescue therapy.

Infliximab three-dose induction regimen in severe corticosteroid-refractory ulcerative colitis: Early and late outcome and predictors of colectomy

“…Thirty-seven patients (33%) were included also in the previous study. 15 Demographics and clinical characteristics of the study group are summarized in Table 1. Ninety-three out of 113 patients (82%) completed the three dose induction regimen, while 20 patients had to discontinue treatment after the first (n = 12) or the second infusion (n = 8).…”

“…[10][11][12][13][14] In a previous study on IIVT-refractory severe UC patients who were treated with IFX as rescue therapy, we reported the results of an Italian open-label study with an overall colectomy rate of 29% after a median follow-up of 23 months. 15 Although in this study there was no predefined IFX infusion regimen and patients received different number of infusions at different time intervals according to clinical judgement, the short-term colectomy rate was significantly higher in patients receiving a single infusion when compared to patients who received two or more infusions.…”

“…In our previous report, including 83 patients with severe IIVT-refractory UC, the early colectomy rate (defined as surgery performed within 2 months) was higher in patients receiving one IFX infusion compared with those receiving two or more infusions (35% vs 5.3%, respectively), suggesting that two or three infusions work better than one single infusion. 15 In the randomised controlled trial by Jarnerot et al, 8 the early colectomy rate after one single IFX infusion was 29%. Similar percentages have been reported in two recently published large observational retrospective studies from Denmark and Sweden, 22,23 in which a flexible IFX induction regimen was used (approximately 50% of patients in both studies received a single IFX infusion).…”

“…This case was already included and discussed in the previous study. 15 Four patients experienced early serious adverse events and discontinued IFX before completing the induction regimen: one patient developed pneumonia 2 months after the second infusion, 1 patient developed systemic cytomegalovirus (CMV) infection, 1 patient developed varicella infection and one patient developed CMV-related hepatitis and pneumonia. One patient had a Candida albicans sepsis that occurred 3 months after the last infusion, and probably it was not related to IFX.…”

Biologic Agents for Inflammatory Bowel Disease (The Current, the Future and the Controversy)

“…The debate between uses of cyclosporine or IFX for patients with fulminant UC has been complicated by the complexity of monitoring cyclosporine IV compared to the ease of giving IFX [Janerot et al 2006]. Additional questions remain regarding the need for long term dosing after anti-TNF induction therapy as ACT studies did not evaluate the long term responses and one may speculate that doses may need adjustment on the long term [Danese et al 2008;Kohn et al 2007]. Some patients were noted to develop anti-drug antibodies and this increased the risk of potential hypersentivity reactions (acute and delayed) as well as secondary loss of response Baert et al 2003].…”