Evaluate The Efficacy Of Infliximab In Crohn’s Disease Based On Real-world Data And Construction Of A Predictive Model

Objective:Endoscopic remission(ER)has become a key therapeutic objective for Crohn’s disease(CD),as achieving remission can enhance prognosis and alter the disease’s course.Clinicians are increasingly concerned with noninvasive evaluation of ER in patients with CD.This study aimed to investigate the predictors of early ER incidence in CD patients treated with infliximab(IFX)and to construct a clinically applicable nomogram to predict early ER incidence in CD patients treated with IFX.Methods:The CD patients initially diagnosed in the Department of Gastroenterology at the First Affiliated Hospital of Nanchang University between January 2017 and August2022 were retrospectively screened based on inclusion and exclusion criteria,and their general characteristics,clinical features,baseline imaging features,and baseline biomarkers were collected.The enrolled patients were randomly divided into development and validation groups in a ratio of 7:3 for the development and validation of nomogram models,respectively.The Simple Endoscopic Score for CD(SES-CD)was used to evaluate ER in colonic and terminal ileum lesions;patients with SES-CD≤2 were classified as the ER group,and those with SES-CD>2 were classified as the non-ER group.To identify the independent predictors of ER,the univariate analysis was used to evaluate the influencing factors of ER,followed by the inclusion of variables with P<0.05 in the multivariate logistic regression analysis.Based on these independent predictors,a nomogram model was constructed and will be validated in the validation group.The area under the curve(AUC)of receiver operating characteristic was utilised to evaluate the discriminatory ability of the prediction model,a calibration curve was applied to evaluate the predictive consistency of the model,and a decision curve analysis(DCA)curve was implemented to evaluate the net clinical benefit of the model.Results:1.This study included 133 CD patients,which were divided into the development group(n=93)and the validation group(n=40).The development group comprised 36(38.7%)patients with ER,while the validation group consisted 16(40%)patients with ER.2.In the development group,ER was associated with age at diagnosis,duration of symptom onset prior to IFX treatment,baseline SES-CD score,diarrhea,mesenteric adipose signal attenuation,CRP,ESR,and AFR(P<0.05)by using univariate analysis.Multivariate logistic regression analysis identified duration of symptom onset to IFX treatment >1 year(OR:0.152;95%CI:0.042-0.551;P=0.004),presence of mesenteric fat signal attenuation(OR:0.219;95%CI:0.066-0.725;P=0.013),and AFR(OR:1.313;95%CI:1.091-1.513;P=0.004)as inhibiting factors for ER after IFX treatment.Based on the three independent predictors identified by multivariate logistic regression,a nomogram model was developed to predict ER.In the development and validation groups,the AUC of the model was 0.854(95%CI:0.777-0.932)and 0.867(95%CI:0.758-0.977)respectively.For the development and validation groups,the Hosmer-Lemeshow test results were P=0.964 and P=0.173,respectively.The most suitable cutoff value for the development group was 0.357,with a sensitivity of 0.833 and a specificity of 0.772 at this value.The optimal cutoff value for the validation group was 0.283,with a sensitivity of 0.875%and a specificity of 0.750%.The calibration curves indicated a strong correlation between the predicted and actual observed values,while the DCA demonstrated the clinical applicability of the nomogram model.Conclusions:1.The duration of symptom onset prior to IFX treatment,the presence of mesenteric adipose signal attenuation,and AFR were independent predictors of ER following IFX treatment.2.The nomogram model established during this study based on the aforementioned three parameters was able to distinguish between ER and NER.The model enables CD patients treated with IFX to predict the incidence of early ER after standard dose treatment with IFX,thereby preventing superfluous endoscopic evaluation and assisting clinicians in making better clinical decisions.