Can Tighter Control Improve the Course of Crohn’s Disease?
BACKGROUND AND PURPOSE:
The goal of treatment in Crohn’s disease is to achieve clinical and endoscopic remission
Biomarkers of intestinal inflammation, such as fecal calprotectin and C-reactive protein (CRP), may be beneficial in the monitoring of patients with Crohn’s disease
Colombel et al. (Lancet, 2017) assessed the endoscopic and clinical outcomes in patients in which these biomarkers were used to direct treatment decisions vs those treated with clinical parameters alone
Open-label, randomized, controlled phase 3 study (RCT)
Patients between ages 18-75 years with active (moderate or severe) endoscopic Crohn’s disease, a Crohn’s Disease Activity Index (CDAI) of 150–450 depending on dose of prednisone at baseline, and no previous use of immunomodulators or biologics
Patients were randomized into the following groups
Tight control based on biomarkers and clinical symptoms
Clinical management only
Groups were stratified after 8 weeks of prednisone induction therapy, or earlier if they had active disease based on
Smoking status (yes or no)
Weight (<70 kg or ≥70 kg)
Disease duration (≤2 years or >2 years)
Both treatment plans were escalated base on meeting treatment failure criteria
The primary outcome was mucosal healing (CDEIS <4) with absence of deep ulcers 48 weeks after randomization
Primary and safety analyses were done in the intention-to-treat population.
244 patients were divided into equal groups
A significantly higher proportion of patients in the tight control group achieved the primary outcomes at week 48 (46%) than in the clinical management group (30%)
The risk difference between groups was 16.1% (95% CI 3.9–28.3; p=0·010)
86% of tight control group and 82% in the clinical management group reported treatment-emergent adverse events; no treatment-related deaths occurred
Timely escalation of therapy combining clinical judgement with biomarkers in patients with early Crohn’s disease results in better clinical and endoscopic outcomes than symptom-driven decisions alone
Future studies should assess the effects of such a strategy on long-term outcomes such as bowel damage, surgeries, hospital admissions, and disability
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