Abstract

Tight control management of Crohn’s disease (CD) based on biomarkers is more effective than conventional clinical management; however, fecal calprotectin is not allowed in Asian and some Western countries. To investigate whether tight control management based on readily available serum biomarkers results in better outcomes, we retrospectively reviewed treatment courses of consecutive Japanese CD patients treated with anti-tumor necrosis factor agents between 2003 and 2018. The association between failure of tight control (C-reactive protein (CRP) ≥ 0.5 mg/dL or albumin (Alb) < 3.8 g/dL at week 8 or 24) and subsequent major adverse outcomes (MAOs; hospitalization related to CD worsening, surgery, and discontinuation due to treatment failure) were analyzed. Among 223 patients followed for >8 weeks, 88 patients experienced MAOs. Multivariate analysis identified penetrating type, CRP ≥ 0.5 mg/dL and Alb < 3.8 g/dL at week 8 as independent risk factors (hazard ratios: 2.16, 2.06, and 2.08, respectively). Among 204 patients followed for >24 weeks, 80 patients experienced MAOs. Penetrating type, CRP ≥ 0.5 mg/dL, and Alb < 3.8 g/dL at week 24 were identified as independent risk factors (2.39, 1.90, and 2.20, respectively). Even in settings without fecal calprotectin, tight control management based on serum CRP and Alb may help avoid MAOs.

Highlights

  • Crohn’s disease (CD) is a chronic inflammatory bowel disease characterized by recurrent episodes of relapse and remission

  • In the clinical management group, the treatment strategy was based on clinical symptoms only, while patients in the tight control group were managed based on clinical symptoms together with serum or fecal biomarkers; treatment failure criteria was set at C-reactive protein (CRP) > 5 mg/L or fecal calprotectin >250 μg/g

  • We sought to investigate whether tight control management based only on serum biomarkers that can be used in routine clinical practice leads to better outcome, and to identify their optimal standards for tight control management in Japanese patients with CD who were treated with anti-tumor necrosis factor (TNF) agents

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Summary

Introduction

Crohn’s disease (CD) is a chronic inflammatory bowel disease characterized by recurrent episodes of relapse and remission. Disease monitoring and treatment optimization aimed at mucosal healing may improve disease prognosis Based on these reports, a treat-to-target approach for CD has been advocated as a strategy to improve prognosis and minimize the need for surgery; this approach entails the use of both clinical and endoscopic remission as indicators[5]. Serum CRP has been shown to be associated with disease activity in CD7,8; it has not been proven to be a reliable serum biomarker of tight control in Asian settings with different susceptibility genes and clinical characteristics from Western countries[9]. Another critical issue is inadequate data on optimal standards of biomarkers including serum CRP. We sought to investigate whether tight control management based only on serum biomarkers that can be used in routine clinical practice leads to better outcome, and to identify their optimal standards for tight control management in Japanese patients with CD who were treated with anti-tumor necrosis factor (TNF) agents

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