Dataset Information

Low Discontinuation Rate of Infliximab Treatment in Steroid-Dependent/Refractory Crohn's Disease Patients.

ABSTRACT:

Background

Many patients with moderate to severe Crohn's disease (CD) are treated with infliximab (IFX). As most of these patients experience a long-lasting therapy, the outcome and withdrawal of IFX treatment are important clinical questions.

Methods

In this retrospective study, we analyzed the treatment outcome in moderate to severe CD patients with a steroid-dependent/refractory disease course started on IFX. Withdrawal of IFX was evaluated in patients with deep remission defined as clinical (Harvey-Bradshaw Index ?4), biochemical (fecal calprotectin [FC] ?150 ?g/g stool) over a period of 2 years, and endoscopic and histological remission before discontinuation of IFX.

Results

After induction with IFX, clinical remission was observed in 45/109 patients (41.3%) and clinical response in 61/109 patients (56.0%). Only 8/109 patients (7.3%) achieved deep remission and therefore could be discontinued from IFX therapy. In 4 of these patients (50%), relapse was observed after discontinuation of IFX treatment. FC decreased in these 8 patients in deep remission from 652 ± 168 ?g/g stool (mean ± SE) at baseline to 24.9 ± 8.1 ?g/g stool at 14 weeks. When compared to patients in deep remission, FC had decreased significantly less at 14 weeks in patients in clinical remission after induction with IFX (n = 31; 154 ± 55 ?g/g stool; p = 0.01), in patients with clinical response after induction achieving clinical remission during the maintenance phase (n = 11; 352 ± 67 ?g/g stool; p = 0.004), or in patients with chronic active disease course on maintenance therapy (n = 50; 645 ± 93 ?g/g stool; p < 0.001).

Conclusion

A low discontinuation rate was observed for steroid-dependent/refractory moderate to severe CD patients with IFX treatment. As FC showed a more or less pronounced decrease depending on the response to the IFX treatment, monitoring of FC may become a noninvasive tool for tailoring biological therapy in CD patients.

SUBMITTER: Kaymak T

PROVIDER: S-EPMC5988174 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Publications

Low Discontinuation Rate of Infliximab Treatment in Steroid-Dependent/Refractory Crohn's Disease Patients.

Kaymak Tanay T Moriconi Federico F Niess Jan H JH Beglinger Christoph C Hruz Petr P

Inflammatory intestinal diseases 20180221 3

<h4>Background</h4>Many patients with moderate to severe Crohn's disease (CD) are treated with infliximab (IFX). As most of these patients experience a long-lasting therapy, the outcome and withdrawal of IFX treatment are important clinical questions.<h4>Methods</h4>In this retrospective study, we analyzed the treatment outcome in moderate to severe CD patients with a steroid-dependent/refractory disease course started on IFX. Withdrawal of IFX was evaluated in patients with deep remission defin ...[more]

PMID: 30018967

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Project description:INTRODUCTION:Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract with an increasing incidence and prevalence worldwide. The early use of anti--tumour necrosis factor agents, such as infliximab, in patients with an aggressive form of Crohn's disease has become part of routine practice. However, infliximab has limitations, and early surgery might benefit patients more. The objective of this study was to compare laparoscopic bowel resection with infliximab treatment in patients with moderately or severely active Crohn's disease with respect to endoscopic remission. The laparoscopic bowel resection combined with infliximab treatment trial is the first randomised controlled trial to demonstrate if early surgery can improve the outcome of patients with Crohn's disease with limited non-stricturing disease treated with infliximab. METHODS AND ANALYSIS:This is a randomised, open-label, controlled trial at Renji Hospital. In this study, a total of 106 adult patients aged 18-80 years with moderately or severely active and steroid-dependent or steroid-resistant Crohn's disease of the distal ileum will be randomly assigned in a 1:1 ratio to the control and surgery groups. The primary outcome is 12-month endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease in the control group and the Rutgeerts score in the surgery group. The secondary outcomes are clinical remission, surgery rate, quality of life, Crohn's disease-related medical costs and Crohn's disease-related morbidity. The patients will be followed up every 6 months after randomisation through intestinal magnetic resonance enterography and colonoscopy for either 3 years or until clinical remission. ETHICS AND DISSEMINATION:All participants will provide informed consent. The protocol has been approved by the Medical Ethical Committee of the Academic Medical Center in Shanghai (No KY2019-180). Results will be disseminated through peer-reviewed journals and scientific conference presentations. TRIAL REGISTRATION NUMBER:ChiCTR2000029323.

Dataset Information

Low Discontinuation Rate of Infliximab Treatment in Steroid-Dependent/Refractory Crohn's Disease Patients.

Background

Methods

Results

Conclusion

Publications

Low Discontinuation Rate of Infliximab Treatment in Steroid-Dependent/Refractory Crohn's Disease Patients.

Similar Datasets

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