Article

Infliximab in Steroid-dependent Ulcerative Colitis: Effectiveness and Predictors of Clinical and Endoscopic Remission.

*Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy †IBD Center, Gastroenterology, IRCCS Humanitas, Milan, Italy ‡General Surgery Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy.
Inflammatory Bowel Diseases (Impact Factor: 5.48). 02/2013; DOI: 10.1097/MIB.0b013e3182802909
Source: PubMed

ABSTRACT BACKGROUND:: Up to 20% of patients with ulcerative colitis (UC) become steroid-dependent during their course. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. Data exploring the use of infliximab in these patients are scarce. Aims of this study were to evaluate the effectiveness of infliximab in steroid-dependent UC and identify predictors of steroid-free remission, mucosal healing (MH), and colectomy. METHODS:: Steroid-dependent UC patients were enrolled and intentionally treated with infliximab. The prospectively designed analyses evaluated (1) steroid-free clinical remission at 6 and 12 months, (2) steroid-free clinical remission and MH at 12 months, and (3) colectomy within 12 months. RESULTS:: One hundred and twenty-six active steroid-dependent UC patients were studied. Of the 126 patients, 36 patients were retrospectively included and 90 patients prospectively enrolled. Steroid-free remission was 53% and 47% at 6 and 12 months, respectively. Predictors of steroid-free remission at 6 and 12 months were thiopurine-naive status (hazard ratio [HR], 2.5 and HR, 2.8, respectively) and combination therapy (HR, 2.1 and HR, 2.2, respectively). At 12 months, 32% were in steroid-free remission and MH. Thiopurine-naive status predicted steroid-free remission and MH (odds ratio, 3.6). C-reactive protein drop to normal after infliximab induction was predictive of steroid-free remission at 6 (HR, 5.9) and 12 months (HR, 4.6) and steroid-free remission and MH at 12 months (odds ratio, 6.0). Twelve patients underwent colectomy after a median of 4.7 months. Steroid sparing significantly reduced the risk of colectomy within 12 months (HR, 0.14). CONCLUSIONS:: Infliximab seems effective in steroid-dependent UC. Thiopurine-naive status and combination therapy significantly increase the rate of steroid-free remission up to 12 months.

0 Followers
 · 
91 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Inflammatory bowel disease (IBD) is a chronic, relapsing intestinal inflammatory disorder with unidentified causes. Both environmental factors and genetic aspects are believed to be crucial to the pathogenesis of IBD. The incidence and prevalence of IBD have recently been increasing throughout Asia, presumably secondary to environmental changes. This increasing trend in IBD epidemiology necessitates specific health care planning and education in Asia. To this end, we must gain a precise understanding of the distinctive clinical and therapeutic characteristics of Asian patients with IBD. The phenotypes of IBD reportedly differ considerably between Asians and Caucasians. Thus, use of the same management strategies for these different populations may not be appropriate. Moreover, investigation of the Asian-specific clinical aspects of IBD offers the possibility of identifying causative factors in the pathogenesis of IBD in this geographical area. Accordingly, this review summarizes current knowledge of the phenotypic manifestations and management practices of patients with IBD, with a special focus on a comparison of Eastern and Western perspectives.
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background and objective There are few data on how histological signs of inflammation develop under treatment with infliximab (IFX). We investigated the patterns of histological features of inflammation in patients with UC in sustained clinical and endoscopic remission under IFX. Methods We performed a retrospective study on 47 patients with UC in clinical and endoscopic remission and undergoing surveillance colonoscopy with biopsies while receiving maintenance therapy with IFX. Each colonic segment was evaluated based on the Mayo endoscopic subscore and the Geboes histology score (range 0−5.4). Results Globally, 6110 biopsy specimens were collected from 235 colonoscopies. At the beginning of the follow-up, histological features of inflammation were found in 48.9% of patients receiving maintenance IFX therapy; 25.9% of them had at least moderate inflammation based on histology scores. At the end of the follow-up, when patients were still under endoscopic and clinical remission, 40.4% of patients had at least one biopsy specimen with evidence of any histological inflammation during the follow-up, and 19.1% had biopsy specimens that met the Geboes criteria for histological inflammation and architectural alteration. In none of the different disease locations (pancolitis, left-sided colitis, distal colitis) histological inflammation improved significantly during the follow-up. Conclusions Patients in clinical and endoscopic remission from UC under IFX still frequently have histological features of inflammation.
    Digestive and Liver Disease 03/2014; 39(1). DOI:10.1016/j.clinre.2014.07.012 · 2.89 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background The benefit of the combination of infliximab (IFX) and immunosuppressant (IS) therapy is debated in ulcerative colitis (UC).AimsTo determine whether the combination of IFX and IS therapy is more effective than infliximab alone for active UC regardless of prior IS use.Methods We identified all controlled trials including patients with moderate-to-severe active UC, treated by either IFX or combined IFX-IS therapy. The main outcome was clinical remission at 4–6 months. Two statistical methods were used, Mantel-Haenszel and Der-Simonian and Laird. Inter-trial heterogeneity was taken into account and publication bias was assessed.ResultsFour controlled trials were analysed and included in the meta-analysis. These four trials included 765 patients, 389 treated with IFX alone and 376 treated with IFX and IS. At 4–6 months' therapy, the clinical remission rate was significantly lower for the IFX monotherapy group OR 0.50, 95% CI [0.34–0.73], P < 0.01 (P-heterogeneity = 0.49). The Harbord test did not show evidence of publication bias (P = 0.29). Calculation of an adjusted OR using the Duval and Tweedie method did not significantly modify results [OR 0.63, 95% CI (0.47–0.85)]. According to Orwin's formula, four additional medium-sized nonsignificant studies would be necessary to reduce the effect size to a nonsignificant value. At 12 months of therapy, there was no significant difference between the two groups: OR 0.60, 95% CI [0.17–2.06], P = 0.41 (P-heterogeneity = 0.01).Conclusion Combination therapy with IFX-IS is more effective than IFX alone for achieving and maintaining clinical remission at 4–6 months for patients with moderate-to-severe ulcerative colitis, regardless of prior IS use.
    Alimentary Pharmacology & Therapeutics 02/2015; DOI:10.1111/apt.13102 · 4.55 Impact Factor