Long-term outcome of treatment with infliximab in 614 patients with Crohn’s disease: results from a single-centre cohort (original) (raw)
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Inflammatory bowel diseases, 2015
Infliximab (IFX) has been used for over a decade worldwide. Less is known about the natural history of IFX use beyond a few years and which patients are more likely to sustain benefits. Patients with Crohn's disease (CD) exposed to IFX from Massachusetts General Hospital, Boston, Saint-Antoine Hospital, Paris, and the Swiss IBD Cohort Study were identified through retrospective and prospective data collection, complemented by chart abstraction of electronic medical records. We compared long-term users of IFX (>5 yr of treatment, long-term users of infliximab [LTUI]), with non-LTUI patients to identify prognostic factors. We pooled data on 1014 patients with CD from 3 different databases, of whom 250 were defined as LTUI. The comparison group comprised 290 patients with CD who discontinued IFX: 48 primary nonresponses, 95 loss of responses, and 147 adverse events. Factors associated with LTUI were colonic involvements and an earlier age at the start of IFX. The prevalence of a...
Infliximab extends the duration until the first surgery in patients with Crohn's disease
BioMed research international, 2013
While biological drugs are useful for relieving the disease activity and preventing abdominal surgery in patients with Crohn's disease (CD), it is unclear whether the use of biological drugs in CD patients with no history of abdominal surgery is appropriate. We evaluated the effects of infliximab and other factors on extending the duration until the first surgery in CD patients on a long-term basis. The clinical records of 104 CD patients were retrospectively investigated. The cumulative nonoperation rate until the first surgery was examined with regard to demographic factors and treatments. The 50% nonoperative interval in the 104 CD patients was 107 months. The results of a univariate analysis revealed that a female gender, the colitis type of CD, and the administration of corticosteroids, immunomodulators, or infliximab were factors estimated to improve the cumulative nonoperative rate. A multivariate analysis showed that the colitis type and administration of infliximab were...
Predictors of response to infliximab in patients with Crohn's disease
Gastroenterology, 2002
All patients with CD who were treated with infliximab at the Cleveland Clinic Foundation or University Hospitals of Cleveland between October 1998 and March 2000 were evaluated in a historical cohort study. Inclusion criteria were (1) age Ͼ18 years; (2) at least 3 months of postinfusion follow-up, calculated after the first infusion of infliximab for patients with Abbreviations used in this paper: CI, confidence interval; HBI, Harvey-Bradshaw Index; IQR, interquartile range; 6-MP, 6-mercaptopurine; OR, odds ratio.
Clinical Gastroenterology and Hepatology, 2006
Background & Aims: The effect of infliximab infused at scheduled intervals on antibody formation, preinfusion trough serum concentrations of infliximab, and their clinical significance was evaluated in patients with Crohn's disease. Methods: Antibodies to infliximab and trough serum infliximab were measured in 105 patients with Crohn's disease treated with 5 mg/kg infliximab for induction followed by maintenance episodic re-treatment (n ϭ 23) or scheduled therapy at 6-to 8-week intervals (n ϭ 82). Results: After a median of 14 infusions (range, 2-45), 21% of patients had detectable antibodies, 25% were antibody negative, and 54% were antibody inconclusive. Antibody formation was higher after episodic compared with scheduled treatment (39% vs 16%; P ϭ .036) and was associated with a higher rate of infusion reactions (50% vs 21%; P ϭ .018). Ninety patients continued maintenance scheduled therapy beyond 12 months including 12 converted episodic patients, with a median follow-up of 23 months (range, 16-68 months). The rate of clinical remission was higher for patients with a detectable trough serum infliximab compared with patients in whom serum infliximab was undetectable, including those without antibodies (82% vs 6%; P Ͻ .001). A detectable trough serum infliximab was also associated with a lower C-reactive protein (2.0 vs 11.8 g/L; P Ͻ .001) and a higher rate of endoscopic improvement (88% vs 33%; P Ͻ .001). Concurrent immunomodulators did not alter outcomes. Methods Patients A consecutive cohort of 105 patients with refractory inflammatory and/or perianal fistulizing Crohn's disease who initiated infliximab treatment between March 2000-February 2005 were studied. At baseline, the induction protocol for fistulizing disease was infliximab 5 mg/kg infused intravenously at 0, 2, and 6 weeks, and for inflammatory disease it was either the 3-dose induction or a single infusion at 5 mg/kg. Thereafter, 82 patients received 5 mg/kg infliximab at regular scheduled intervals of 6, 7, or 8 weeks, and 23 patients were provided infliximab on relapse of the disease. Concomitant therapy, including prednisone at a dosage of Յ15 mg/day, azathioprine (2.0-2.5 mg • kg Ϫ1 • day Ϫ1), methotrexate (25 mg intramuscu-Abbreviations used in this paper: ANOVA, analysis of variance; CRP, C-reactive protein; HBI, Harvey-Bradshaw Index; TNF, tumor necrosis factor.
The American Journal of Gastroenterology, 2002
Objective: Infliximab is an effective treatment for refractory or fistulizing Crohn's disease (CD). However, about 30% of patients do not respond to infliximab for unknown reasons. Identifying predictive factors of response is important for optimizing clinical management and for better understanding infliximab's mechanisms of action. The aim of this study was to assess whether demographic or clinical parameters influence short-term response to infliximab. Methods: The first 240 CD patients of the Belgian Infliximab Expanded Access Program were studied for response to infliximab treatment and assessed at 4 (refractory luminal CD) or 10 wk (fistulizing CD) after the first infusion. Detailed demographic and clinical information on age, sex, type of disease (fistulizing or refractory), Crohn's Disease Activity Index score, C-reactive protein (CRP), smoking habits, disease duration, localization of disease, concomitant medication, and previous surgery were obtained from all patients. Logistic regression and decision tree analysis were performed. Results: There were 73.5% responders and 26.5% nonresponders to treatment. Stepwise logistic regression identified age (OR = 0.971, 95% CI = 0.947-0.995, p = 0.018), isolated ileitis (OR = 0.359, 95% CI = 0.177-0.728, p = 0.004), and previous surgery (OR = 0.429, 95% CI = 0.233-0.787, p = 0.006) as inversely correlated with response, whereas isolated colitis (OR = 1.905, 95% CI = 1.010-3.597, p = 0.046) and concomitant immunosuppressive treatment (OR = 2.670, 95% CI = 1.430-5.016, p = 0.0022) were positively correlated with response to infliximab. Surprisingly, smoking habits were not retained as predictors for response. Decision tree analysis provided a working algorithm based on age and immunosuppressive treatment that warrants further exploration. Conclusions: In this large cohort of infliximab-treated CD patients, young age, Crohn's colitis, and concomitant immunosuppressive treatment were identified as independent variables favoring short-term response to infliximab.
Infliximab for Crohn’s Disease: More Than 13 Years of Real-world Experience
Inflammatory Bowel Diseases, 2018
Background: The purpose of this study was to compare the long-term safety of infliximab and nonbiologic agents as Crohn's disease (CD) therapy. Methods: Patients with CD were prospectively evaluated in this large, observational registry. Results: Patients (n = 6273) participated in this observational registry from July 1999 through March 2012; 3440 (54.8%) received infliximab (20,971 patient-years), and 2833 (45.2%) received other treatments only (14,806 patient-years). Overall, 59,875 infliximab infusions were
Gastroenterología y hepatología
BACKGROUND: Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response. METHODS: Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14wks. RESULTS: 169 patients included (48%males, mean age 39 ± 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 4 8 % remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients. CONCLUSIONS: Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.