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Exploring the concept of deep remission in Crohn's disease: correlation between transmural healing and biomarkers
Fabiana Castiglione1, Nicola Imperatore2, Anna Testa3
1Gastroenterology Unit, Department of Clinical Medicine and Surgery, 'Federico II' School of Medicine, Naples, Italy, Via S. Pansini 5, Naples 80131, Italy.
Insights
Deep remission (DR) in Crohn's disease (CD) is defined by achieving clinical remission (CR), mucosal healing (MH), and transmural healing (TH) with specific biomarker levels. Approximately 30% of CD patients on biologics can attain this deep remission state.
Area of Science:
- Gastroenterology
- Inflammatory Bowel Disease Research
- Clinical Biomarker Analysis
Background:
- Mucosal healing (MH) and transmural healing (TH) are key outcomes in Crohn's disease (CD), but the clinical significance of deep remission (DR) remains underexplored.
- Understanding DR is crucial for optimizing treatment strategies and predicting patient outcomes in CD management.
Purpose of the Study:
- To define deep remission (DR) by correlating mucosal healing (MH), transmural healing (TH), and specific biomarker levels (fecal calprotectin [FC] and C-reactive protein [CRP]) in Crohn's disease (CD) patients.
- To establish target FC and CRP cut-off values indicative of MH and TH, thereby defining DR in a real-world setting.
Main Methods:
- A longitudinal, observational study evaluated clinical remission (CR), MH, and TH rates in 118 consecutive CD patients receiving biologic therapy.
- Receiver operating characteristic (ROC) curve analysis identified optimal FC (<94 μg/g) and CRP (<5 mg/L) cut-offs associated with MH and TH.
- Deep remission (DR) was defined as the achievement of concomitant CR, MH, and TH, coupled with the established target biomarker levels.
Main Results:
- In 118 CD patients, CR, MH, and TH were achieved by 62.7%, 44.1%, and 32.2%, respectively.
- An FC level <94 μg/g demonstrated high sensitivity and specificity for both MH and TH (AUC 0.95 and 0.88, respectively).
- A CRP level <5 mg/L also correlated with MH and TH (AUC 0.85 and 0.78, respectively).
- Deep remission (DR), defined by CR, MH, TH, and target biomarker levels (FC <94 μg/g, CRP <5 mg/L), was achieved by 27.9% (33 patients).
Conclusions:
- Biomarker thresholds of FC <94 μg/g and CRP <5 mg/L are associated with clinical remission (CR), mucosal healing (MH), and transmural healing (TH) in Crohn's disease (CD) patients on biologics.
- These biomarker levels can be incorporated into the definition of deep remission (DR).
- Approximately 30% of CD patients undergoing maintenance biologic therapy may achieve deep remission (DR).
Background:
While mucosal healing (MH) and transmural healing (TH) predict relevant clinical outcomes in Crohn's disease (CD), little is known about the real significance and clinical impact of deep remission (DR).
Objectives:
To better explore the concept of DR, toward a direct correlation between MH, TH, and biomarkers.
Design:
Real-world observational longitudinal study to evaluate the rate of clinical remission (CR), MH and TH, and the fecal calprotectin (FC)/C-reactive protein (CRP) levels in all consecutive CD patients on biologics.
Methods:
A receiver operating characteristic (ROC) curve was constructed to define the best FC and CRP cut-offs associated with MH and TH. Finally, patients achieving CR, MH, and TH, in association with the target FC/CRP values, were considered in DR.
Results:
Among 118 CD patients, CR, MH, and TH were achieved in 62.7, 44.1, and 32.2%, respectively. After 2 years, the mean FC levels decreased from 494 ± 15.4 μg/g to 260 ± 354.9 μg/g (p < 0.01). Using the ROC curve analysis, an FC cut-off value of 94 μg/g was associated with both MH [sensitivity: 94.2%, specificity: 84.8%, positive predictive value (PPV): 83.05%, negative predictive value (NPV): 94.92%, area under the curve (AUC): 0.95] and TH (sensitivity: 92.1%, specificity: 70%, PPV: 64.4%, NPV: 94.9%, AUC: 0.88). CRP < 5 mg/L was associated with both MH (sensitivity: 96.1%, specificity: 62.1%, PPV: 66.7%, NPV: 95.35%, AUC: 0.85) and TH (sensitivity: 97.4%, specificity: 52.5%, PPV: 52%, NPV: 95.35%, AUC: 0.78). When considering CD patients with concomitant CR, MH, and TH associated with an FC < 94 μg/g and CRP < 5 mg/L, this association was found identified in 33 patients (27.9%).
Conclusion:
An FC < 94 μg/g and a normal CRP are associated with CR, MH, and TH and could be included in the definition of DR in association. So by definition, DR could be achieved in approximately 30% of CD patients during maintenance treatment with biologics.
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