Nomogram to predict primary non-response to infliximab in patients with Crohn’s disease: a multicenter study

Abstract Background Infliximab (IFX) is effective at inducing and maintaining clinical remission and mucosal healing in patients with Crohn’s disease (CD); however, 9%–40% of patients do not respond to primary IFX treatment. This study aimed to construct and validate nomograms to predict IFX response in CD patients. Methods A total of 343 patients diagnosed with CD who had received IFX induction from four tertiary centers between September 2008 and September 2019 were enrolled in this study and randomly classified into a training cohort (n = 240) and a validation cohort (n = 103). The primary outcome was primary non-response (PNR) and the secondary outcome was mucosal healing (MH). Nomograms were constructed from the training cohort using multivariate logistic regression. Performance of nomograms was evaluated by area under the receiver-operating characteristic curve (AUC) and calibration curve. The clinical usefulness of nomograms was evaluated by decision-curve analysis. Results The nomogram for PNR was developed based on four independent predictors: age, C-reactive protein (CRP) at week 2, body mass index, and non-stricturing, non-penetrating behavior (B1). AUC was 0.77 in the training cohort and 0.76 in the validation cohort. The nomogram for MH included four independent factors: baseline Crohn’s Disease Endoscopic Index of Severity, CRP at week 2, B1, and disease duration. AUC was 0.79 and 0.72 in the training and validation cohorts, respectively. The two nomograms showed good calibration in both cohorts and were superior to single factors and an existing matrix model. The decision curve indicated the clinical usefulness of the PNR nomogram. Conclusions We established and validated nomograms for the prediction of PNR to IFX and MH in CD patients. This graphical tool is easy to use and will assist physicians in therapeutic decision-making.

Download Full-text

A nomogram for predicting the response to exclusive enteral nutrition in adult patients with isolated colonic Crohn’s disease

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284819881301 ◽

2019 ◽

Vol 12 ◽

pp. 175628481988130

Author(s):

Yihan Xu ◽

Zhen Guo ◽

Liangyu Huang ◽

Jianfeng Gong ◽

Yi Li ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Enteral Nutrition ◽

Predictive Factors ◽

Clinical Remission ◽

Validation Cohort ◽

Characteristic Curve ◽

Adult Patients ◽

Exclusive Enteral Nutrition ◽

Colonic Lesion

Background: Isolated colonic Crohn’s disease (cCD) responds less well to induction therapy with exclusive enteral nutrition (EEN) compared with ileal or ileocolonic disease in adult patients; therefore, we aimed to identify the factors that influence the response to EEN and develop a predictive nomogram model to optimize the use of EEN in cCD patients. Materials and methods: Eighty-five cCD patients treated with EEN as first-line therapy at our center between 1 June 2012 and 30 June 2018 were retrospectively analyzed as the primary cohort. The primary endpoint was clinical remission after EEN therapy. Potential predictive factors for the efficacy of EEN were assessed by univariate and multivariate analyses, and a nomogram to predict the response to EEN therapy in cCD patients was designed. Another 19 cCD patients were retrospectively included in the validation cohort to verify the accuracy of the nomogram model. Results: The clinical remission rates for the primary cohort and validation cohort were 52.9% and 47.4%, respectively. Pancolitis was the greatest contributor to the risk of failure to respond to EEN [odds ratio (OR) = 4.896; 95% confidence interval (CI) = 1.223–19.607; p = 0.025], lean body mass index (LBMI), colonic lesion features, simple endoscopic scores for Crohn’s disease, C-reactive protein before treatment and ∆prealbumin were also related to the efficacy of EEN in cCD. The nomogram model showed robust discrimination, with an area under the receiving operating characteristic curve of 0.906. Conclusion: Several predictive factors for response to EEN therapy in cCD adult patients were identified, and a promising nomogram that can predict the effect of EEN in cCD was developed.

Download Full-text

Development and Validation of a New Algorithm Model for Differential Diagnosis Between Crohn's Disease and Intestinal Tuberculosis: A Combination of Laboratory, Imaging and Endoscopic Characteristics

10.21203/rs.3.rs-176405/v1 ◽

2021 ◽

Author(s):

Yi Lu ◽

Yonghe Chen ◽

Xiang Peng ◽

Jiayin Yao ◽

Weijie Zhong ◽

...

Keyword(s):

Multivariate Analysis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Validation Cohort ◽

Intestinal Tuberculosis ◽

Regression Tree ◽

R Package ◽

Classification And Regression Tree ◽

Aphthous Ulcer ◽

Training Cohort

Abstract Background: Sometimes in clinical practice, it was a great challenge to distinguish Crohn's disease (CD) and intestinal tuberculosis (ITB), we conducted this study was to identify simple and useful algorithm for distinguishing them.Methods: We retrospectively reviewed the medical history of the patients who were diagnosed as ITB or CD. We firstly identified ITB patients, and then the patients diagnosed with CD were matched by age, sex, and admission time in a 1:1 ratio. Patients who admitted between May 1, 2013 and April 30, 2019 were regarded as training cohort, and patients admitted between May 1, 2019 and May 1, 2020 were regarded as validation cohort. We used multivariate analysis to identify the potential variables, and then we used R package rpart to build the classification and regression tree (CART), and validated the newly developed model.Results: In total, the training cohort included 84 ITB and 84 CD patients, the validation cohort included 22 ITB and 22 CD patients. Multivariate analysis showed that, positive T-SPOT, ≥4 segments involved, longitudinal ulcer, circular ulcer, and aphthous ulcer were confirmed as independent discriminating factors. Using these parameters to build the CART model made an overall accuracy rate was 88.64%, with sensitivity, specificity, NPV, and PPV being 90.91%, 86.36%, 90.48% and 86.96%, respectively.Conclusion: We developed a simple and novel algorithm model covering laboratory, imaging, and endoscopy parameters with CART to differentiate ITB and CD with good accuracy.

Download Full-text

Development and validation of a new algorithm model for differential diagnosis between Crohn's disease and intestinal tuberculosis: a combination of laboratory, imaging and endoscopic characteristics

BMC Gastroenterology ◽

10.1186/s12876-021-01838-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yi Lu ◽

Yonghe Chen ◽

Xiang Peng ◽

Jiayin Yao ◽

Weijie Zhong ◽

...

Keyword(s):

Multivariate Analysis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Validation Cohort ◽

Intestinal Tuberculosis ◽

Regression Tree ◽

Classification And Regression Tree ◽

Aphthous Ulcer ◽

Training Cohort ◽

Longitudinal Ulcer

Abstract Background Sometimes in clinical practice, it is a great challenge to distinguish Crohn's disease (CD) and intestinal tuberculosis (ITB), we conducted this study to identify simple and useful algorithm for distinguishing them. Methods We retrospectively reviewed the medical history of the patients who were diagnosed as ITB or CD. We firstly identified ITB patients, and then the patients diagnosed with CD were matched by age, sex, and admission time in a 1:1 ratio. Patients who admitted between May 1, 2013 and April 30, 2019 were regarded as training cohort, and patients admitted between May 1, 2019 and May 1, 2020 were regarded as validation cohort. We used multivariate analysis to identify the potential variables, and then we used R package rpart to build the classification and regression tree (CART), and validated the newly developed model. Results In total, the training cohort included 84 ITB and 84 CD patients, the validation cohort included 22 ITB and 22 CD patients. Multivariate analysis showed that, positive interferon-gamma release assays (IGRAs), ≥ 4 segments involved, longitudinal ulcer, circular ulcer, and aphthous ulcer were confirmed as independent discriminating factors. Using these parameters to build the CART model made an overall accuracy rate was 88.64%, with sensitivity, specificity, NPV, and PPV being 90.91%, 86.36%, 90.48% and 86.96%, respectively. Conclusion We developed a simple and novel algorithm model covering laboratory, imaging, and endoscopy parameters with CART to differentiate ITB and CD with good accuracy. Positive IGRAs and circular ulcer were suggestive of ITB, while ≥ 4 segments involved, longitudinal ulcer, and aphthous ulcer were suggestive of CD.

Download Full-text

The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease

Case Medical Research ◽

10.31525/ct1-nct04233463 ◽

2020 ◽

Author(s):

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Response ◽

Mucosal Healing ◽

Adult Patients ◽

Newly Diagnosed ◽

Tgf Beta ◽

Beta 2

Download Full-text

Faculty Opinions recommendation of Detection of small bowel mucosal healing and deep remission in patients with known small bowel crohn's disease using biomarkers, capsule endoscopy, and imaging.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725679062.793520455 ◽

2016 ◽

Author(s):

Marco Pennazio ◽

Anastasios Koulaouzidis

Keyword(s):

Crohn’S Disease ◽

Small Bowel ◽

Crohn's Disease ◽

Capsule Endoscopy ◽

Mucosal Healing

Download Full-text

Apex Score: Predicting Flares in Small-Bowel Crohn’s Disease After Mucosal Healing

Digestive Diseases and Sciences ◽

10.1007/s10620-021-07148-2 ◽

2021 ◽

Author(s):

Vítor Macedo Silva ◽

Marta Freitas ◽

Pedro Boal Carvalho ◽

Francisca Dias de Castro ◽

Tiago Cúrdia Gonçalves ◽

...

Keyword(s):

Crohn’S Disease ◽

Small Bowel ◽

Crohn's Disease ◽

Mucosal Healing

Download Full-text

Higher concentrations of cytokine blockers are needed to obtain small bowel mucosal healing during maintenance therapy in Crohn's disease

Alimentary Pharmacology & Therapeutics ◽

10.1111/apt.16551 ◽

2021 ◽

Author(s):

Kento Takenaka ◽

Ami Kawamoto ◽

Shuji Hibiya ◽

Kohei Suzuki ◽

Toshimitsu Fujii ◽

...

Keyword(s):

Crohn’S Disease ◽

Small Bowel ◽

Crohn's Disease ◽

Maintenance Therapy ◽

Mucosal Healing

Download Full-text

P089 REAL-WORLD EXPERIENCE: CLINICAL AND ENDOSCOPIC EFFECTIVENESS OF STANDARD VEDOLIZUMAB DOSING AND MODIFIED MAINTENANCE DOSING IN PATIENTS WITH MODERATE-SEVERE CROHN’S DISEASE

Inflammatory Bowel Diseases ◽

10.1093/ibd/zaa010.187 ◽

2020 ◽

Vol 26 (Supplement_1) ◽

pp. S75-S75

Author(s):

Scott D Lee ◽

Anand Singla ◽

Caitlin Kerwin ◽

Kindra Clark-Snustad

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Adverse Events ◽

Real World ◽

Clinical Remission ◽

Mucosal Healing ◽

Clinical Disease ◽

Endoscopic Remission ◽

Starting Dose

Abstract Background Vedolizumab (VDZ) is an effective treatment for Crohn’s disease (CD); however, inadequate and loss of response is common. Pivotal VDZ trials evaluated alternative dosing intervals, demonstrating numeric but not statistical superiority in efficacy as compared to FDA-approved dosing. The safety and effectiveness of FDA-approved and modified-dosing schedules in a real-world population are unknown. We aimed to evaluate clinical and endoscopic effectiveness & safety of standard and modified maintenance VDZ dosing in a real world cohort. Methods We retrospectively reviewed CD patients (pts) treated with >3 months VDZ, assessing Harvey Bradshaw Index (HBI), Simple Endoscopic Score for Crohn’s disease (SESCD), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), C-reactive protein (CRP), albumin and hematocrit prior to and following standard VDZ dosing, and prior to and following modified VDZ maintenance dosing. We measured duration on therapy and adverse events. Results We identified 226 eligible pts, mean age 41.5 years, 55.3% female, median disease duration 10 years, 88.9% with prior biologic exposure. Mean duration on VDZ was 28.3 months. Standard VDZ dosing: 61.5% of pts with active clinical disease and adequate follow up data achieved clinical response after 3–12 months; 41.0% had clinical remission. 51.9% of pts with active endoscopic disease and adequate follow up data achieved mucosal improvement; 42.3% had endoscopic remission; 26.0% had mucosal healing after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized CRP after 3–12 months. Modified maintenance dosing: 72 non-remitters to standard VDZ dosing received modified VDZ maintenance dosing. 51.5% of pts with active clinical disease prior to starting dose modification and adequate follow up data achieved clinical response after 3–12 months of modified maintenance dosing; 42.4% had clinical remission. 22.2% of pts with SESCD ≥3 prior to starting dose modification achieved mucosal improvement after 3–24 months; 22.2% had mucosal healing. 26.7% of pts with SESCD ≥4 prior to starting modified dosing had endoscopic remission after 3–24 months. 50.0% of pts with elevated CRP and adequate follow up data normalized their CRP after 3–12 months. Safety: 82.7% of pts reported ≥1 adverse events, most commonly infection and worsening CD symptoms. Discussion Standard VDZ dosing resulted in clinical and endoscopic improvement in pts with moderate-severe CD, with prior exposure to multiple advanced therapies. For non-remitters to standard dosing, modified VDZ maintenance dosing improved clinical disease activity in ∼50% of pts and improved endoscopic disease activity in ∼20% of pts, suggesting that for pts who did not achieve remission with standard VDZ dosing, modified VDZ dosing may result in clinical and endoscopic improvement.

Download Full-text