Use of Accelerated Induction Strategy of Infliximab for Ulcerative Colitis in Hospitalized Patients at a Tertiary Care Center.

BACKGROUND: Infliximab can prevent colectomy in patients hospitalized with acute severe ulcerative colitis (ASUC). In cases of ASUC, fecal losses of infliximab may lead to low drug levels and reduced efficacy. AIM: To determine 90-day colectomy risk and postoperative complications in patients receiving single-dose and accelerated induction of infliximab for ASUC. METHODS: We conducted a retrospective review of patients hospitalized with ASUC requiring infliximab therapy between 2013 and 2017 at the University of Michigan. Patients were excluded if they had an enteric infection, received an anti-TNF previously, or received cyclosporine during the same admission. The primary outcome was colectomy within 90 days of admission. Patients receiving single-dose induction infliximab were compared to those receiving accelerated rescue induction with two doses of infliximab prior to day 14. Administration of accelerated induction was guided by a protocol, suggesting administering a second dose of infliximab to those with only a partial response in CRP 3 days after the initial dose. Postoperative outcomes including 30-day readmission rates and complications were compared using descriptive statistics. RESULTS: From 2013 to 2017, 66 patients with ASUC met our criteria. Thirty-three received accelerated induction (50.0%). The colectomy rate in the accelerated induction group was 30.3% versus 24.2% in the single-dose induction group (p = 0.58). There was no detected difference in postoperative outcomes between the accelerated and single-dose rescue induction. CONCLUSIONS: In this retrospective review, 69.7% of those failing to respond to single-dose infliximab were able to avoid colectomy with an accelerated rescue induction strategy without worsening postoperative outcomes. Larger studies of accelerated dosing infliximab are needed.

Prevalence and Effect of Intestinal Infections Detected by a PCR-Based Stool Test in Patients with Inflammatory Bowel Disease.

BACKGROUND: The advent of PCR-based stool testing has identified a greatly increased number of infectious agents in IBD, but their clinical significance is unknown. AIMS: To determine the infectious agent prevalence and the clinical significance of these infectious agents in IBD patients. METHODS: This cross-sectional study compared the prevalence of GI infections among IBD patients with active and quiescent disease versus healthy controls. Among actively inflamed patients, we compared clinical characteristics, medication use, and disease course between those with positive and negative tests. RESULTS: Three hundred and thirty-three IBD patients and 52 healthy volunteers were included. The IBD group was divided into active Crohn's disease (CD, n = 113), inactive CD (n = 53), active ulcerative colitis (UC, n = 128), and inactive UC (n = 39). A significantly higher percentage of actively inflamed patients had positive stool tests (31.1%) compared to those with quiescent disease (7.6%, P = < 0.001) and healthy controls (13.5%, P = 0.01). In actively inflamed patients, shorter symptom duration and the use of multiple immunosuppressive agents were significantly associated with positive stool tests. Escalation of immunosuppressive therapy was less frequent in those with positive (61.3%) than with negative tests (77.7%, P = < 0.01). However, the need for surgery (13.3% vs. 18.7%, respectively, P = 0.31) and hospitalization (14.7% vs. 17.5%, respectively, P = 0.57) in 90 days was not significantly different. CONCLUSION: GI infections are common in IBD patients with active disease. Evaluating patients for infection may help avoid unnecessary escalation of immunosuppressants, especially during an acute flare or combination immunosuppression.

Preoperative predictors of choledocholithiasis in patients presenting with acute calculous cholecystitis.

BACKGROUND AND AIMS: Markedly increased liver chemistries in patients presenting with acute calculous cholecystitis (AC) often prompt an evaluation for concomitant choledocholithiasis (CDL). However, current guidelines directing the workup for CDL fail to address this unique population. The aims of this study are to define the range of presenting laboratory values and imaging findings in AC, develop a model to predict the presence of concurrent CDL, and develop a management algorithm that can be easily applied on presentation. METHODS: We conducted a retrospective review of patients presenting with AC to a large tertiary hospital over a 3.5-year period. CDL was defined as common bile duct (CBD) stone(s), sludge, or debris seen on any of the following studies: US, CT, magnetic resonance imaging/MRCP, EUS, ERCP, or intraoperative cholangiogram. A multivariable model to predict CDL was developed on 70% of the patients and validated on the remaining 30%. RESULTS: A total of 366 patients were identified and 65 (17.8%) had concurrent CDL. Univariable analysis was used to predict CDL and demonstrated statistically significant odds ratios for transaminases >3 times the upper limit of normal, alkaline phosphatase (AlkPhos) above normal, lipase >3 times the upper limit of normal, total bilirubin ≥1.8 mg/dL, and CBD diameter >6 mm. In the validation cohort, an optimal model containing alanine transaminase (ALT) >3 times the upper limit of normal, abnormal AlkPhos, and CBD diameter >6 mm was found to have an area under the receiver operating curve of 0.91. When 0 or 1 risk factors were present, 98.6% of patients did not have CDL. When all 3 risk factors were present, 77.8% were found to have CDL. CONCLUSIONS: The prevalence of CDL is high among patients with AC. When a validated model is used, application of cutoffs for ALT, AlkPhos, and CBD diameter can effectively triage patients with low and high likelihood for CDL to surgery or ERCP, respectively.

Defining an Optimal Adherence Threshold for Patients Taking Subcutaneous Anti-TNFs for Inflammatory Bowel Diseases.

OBJECTIVES: In patients with inflammatory bowel disease (IBD) using biological therapy, non-adherence leads to anti-drug antibody formation and reduced effectiveness. Little is known about the optimal level of adherence in IBD patients on biologic therapy. We aimed to identify the association between adherence and disease flare and determine an optimal level of adherence. METHODS: We analyzed claims data for IBD patients prescribed adalimumab (ADA) and certolizumab (CZP) from the Truven Health MarketScan Commercial Claims and Encounters database from 2009 to 2013. Adherence was calculated using the medication possession ratio (MPR) from initiation until flare occurrence. A disease flare was defined as any hospitalization or new steroid prescription>90-days after drug initiation. The optimal MPR was determined using log-rank testing. The association between the optimal MPR and flare was assessed using multivariable Cox-Proportional hazards ratio. RESULTS: There were 6,048 patients who were prescribed ADA (n=5,325) or CZP (n=723) for IBD. The average age was 41 years (±15) and 54% were female. The optimal MPR identified was 0.86 for ADA and 0.87 for CZP; 24% of the patients were below this level. Adjusting for age, gender, and concomitant medications at initiation, patients who were adherent above these levels had a 25% lower risk of flare for ADA (HR: 0.75, 95%CI: 0.67-0.83, P<0.01) and 41% lower risk for CZP (HR: 0.59, 95%CI: 0.46-0.76, P<0.01). CONCLUSIONS: Patients who delay refills >2 days on average every 2 weeks of their subcutaneous biologics have significantly increased risk of flare. Further studies to improve adherence among those patients who consistently delay medication use are necessary.

Systemic Inflammatory Responses in Ulcerative Colitis Patients and Clostridium difficile Infection.

BACKGROUND/AIMS: Finding differences in systemic inflammatory response in ulcerative colitis (UC), UC with Clostridium difficile infection (CDI), and CDI could lead to a better ability to differentiate between UC with symptomatic CDI and UC with C. difficile colonization, and could identify specific inflammatory pathways for UC or CDI, which could be therapeutic targets. METHODS: We prospectively collected sera from symptomatic UC patients whose stools were tested for toxigenic C. difficile, and from CDI patients who did not have UC (CDI-noUC). The UC patients with positive tests (UC-CDI) were further categorized into responders to CDI treatment (UC-CDI-R) and non-responders (UC-CDI-NR). We compared serum inflammatory mediators among groups using unadjusted and adjusted multivariable statistics. RESULTS: We included 117 UC [27 UC-CDI, 90 UC without CDI (UC-noCDI)] and 16 CDI-noUC patients. Principal component analysis (PCA) did not reveal significant differences either between UC-CDI and UC-noCDI groups, or between UC-CDI-R and UC-CDI-NR groups. In contrast, the PCA showed significant separation between the UC and CDI-noUC groups (P = 0.002). In these two groups, hepatocyte growth factor (HGF) and chemokine (C-C motif) ligand 2 (CCL2) levels were significantly lower and IL-23 levels were higher in UC patients in multivariable analyses. The model to distinguish UC from CDI including IL-23, HGF, CCL2, age, gender, and HGB had an AuROC of 0.93. CONCLUSION: Inflammatory profiles could not distinguish UC-CDI from UC-noCDI, and UC-CDI-R from UC-CDI-NR. However, the UC and CDI-noUC groups were significantly different. Future work should examine whether therapeutic agents inhibiting IL-23 or stimulating HGF can treat UC.

Factors That Predict High Health Care Utilization and Costs for Patients With Inflammatory Bowel Diseases.

BACKGROUND & AIMS: A subset of patients with inflammatory bowel diseases (IBD) have continuously active inflammation, leading to a high number of complications and high direct health care costs (diagnostic tests, medications, and surgeries) and indirect costs (reduced employment and productivity and fewer opportunities for activities). Identifying these high-risk patients and providing effective interventions could produce better outcomes and reduce costs. We used prior year data to create IBD risk models to predict IBD-related hospitalizations, emergency department visits, and high treatment charges (>$30,000/year) in the subsequent year. METHODS: We performed a retrospective study of medical records from all patients with IBD treated at the University of Michigan Hospital from fiscal years 2013-2015. We selected clinical variables from the prior year and tested their abilities to predict 3 adverse outcomes (IBD-related hospitalizations, emergency department visits, and treatment charges >$30,000/year) in the subsequent year. Individual patients were only included once in the data set. We created a multivariate model that was based on a 70% randomly selected cohort (1005 patients) and validated the model on the other 30% (425 patients). Logistic regression was used for bivariate and multivariate analyses. RESULTS: Factors that predicted high-cost outcomes included the presence of psychiatric illness, use of corticosteroids, use of narcotics, low levels of hemoglobin, and high numbers of IBD-related hospitalizations. In the validation cohort, the model predicted IBD-related hospitalizations, emergency department visits, and high charges in the following year with receiver operating characteristic curve values of 0.751, 0.738, and 0.744, respectively. CONCLUSIONS: We identified 5 factors that can effectively identify patients with IBD at high risk for hospitalization, emergency department visits, and high treatment charges in the next year. These patients should be closely monitored and aggressively managed.

Intestinal Dilation and Platelet:Albumin Ratio Are Predictors of Surgery in Stricturing Small Bowel Crohn's Disease.

BACKGROUND & AIMS: It is a challenge to predict how patients with small bowel Crohn's disease (CD) will respond to intensified medical therapy. We aimed to identify factors that predicted surgery within 2 years of hospitalization for CD, to guide medical versus surgical management decisions. METHODS: We performed a retrospective review of adults hospitalized for small bowel CD from 2004 through 2012 at a single academic referral center. Subjects underwent abdominal computed tomography or magnetic resonance imaging within 3 weeks of hospitalization. Imaging characteristics of small bowel dilation, bowel wall thickness, and disease activity were assessed by a single, blinded radiologist. Multivariate analysis by Cox proportional hazards regression techniques was used to generate a prediction model of intestinal resection within 2 years. RESULTS: A total of 221 subjects met selection criteria, with 32.6% undergoing surgery within 2 years of index admission. Bivariate analysis showed high-dose steroid use (>40 mg), ongoing treatment with anti-tumor necrosis factor agents at admission, platelet count, platelet:albumin ratio, small bowel dilation (≥35 mm), and bowel wall thickness to predict surgery (P ≤ .01). Multivariate modeling demonstrated small bowel dilation >35 mm (hazard ratio, 2.92; 95% confidence interval, 1.73-4.94) and a platelet:albumin ratio ≥125 (hazard ratio, 2.13; 95% confidence interval, 1.15-3.95) to predict surgery. Treatment with anti-tumor necrosis factor agents at admission conferred a nonsignificant increased trend for risk of surgery (hazard ratio, 1.61; 95% confidence interval, 0.994-2.65). CONCLUSIONS: Small bowel dilation >35 mm and high platelet:albumin ratios are independent and synergistic risk factors for future surgery in patients with structuring small bowel CD. Platelet:albumin ratios may capture the relationship between acute inflammation and cumulative damage and serve as markers of intestinal disease that cannot be salvaged with medical therapy.

Risk stratification of emergency department patients with Crohn's disease could reduce computed tomography use by nearly half.

BACKGROUND & AIMS: Computed tomography (CT) is a useful tool for assessing disease activity and excluding complications in patients with Crohn's disease (CD). However, excessive radiation increases risk for malignancy. We aimed to identify automatable algorithms with high negative predictive values for significant CT findings in patients with CD who present at the emergency department. METHODS: We conducted a retrospective review of a tertiary center's medical records to identify adults diagnosed with CD who presented from 2000 through 2011. Logistic regression was used to model complications (perforations, abscesses, or other serious findings) and inflammation. RESULTS: There were 1095 visits made by 613 individuals that included a CT scan within 24 hours of arrival. The average number of CT scans was 1.8 (range, 1-31). Complications of CD were observed in 16.8% of CT scans, inflammation in 54.5%, and new/worse findings in 67.2%. On the basis of 10-fold cross-validation, the area under the receiver operating characteristic curve value for the complications model was 0.80 (95% confidence interval, 0.74-0.86) and for the inflammation model was 0.71 (95% confidence interval, 0.68-0.74). Scanning only patients with model-predicted complications would reduce scans by 43.0%, with a miss rate of 0.8% (4 of 491). CONCLUSIONS: Patients presenting to the emergency department with CD are frequently assessed by CT. However, no significant findings are observed in 32.8%, and only 17% have complications from CD. We created models to identify patients not likely to have significant findings from CT with high negative predictive values; these could aid physicians in avoiding CT scans for many patients. Studies are needed to validate these models beyond a single center.

Anti-adhesion therapies and the rule of 3 for rare events.

During the open-label trial of natalizumab for Crohn's disease, an isolated case of progressive multifocal leukoencephalopathy (PML) was found. This prompted a more careful review by regulators, physicians, and the pharmaceutical industry. A new gut-specific monoclonal antibody, vedolizumab, has been shown to be effective in inflammatory bowel disease, and in continued trials no patients have developed PML. Given the mortality of PML and lack of effective treatments, patients may remain concerned that PML is a possible risk factor. So, going forward, how do we quantify the risk of this serious adverse event? This review details how we define the maximum risk when no (or very few) events have occurred with an easy-to-use equation.

Dupilumab-Induced Pancreatitis.

Drug-induced pancreatitis (DIP) is a rare cause of pancreatitis with an extensive and growing list of offending medications. Drawing a causative relationship between a medication and pancreatitis can be challenging, requiring a thorough workup to exclude other potential etiologies. By using scoring systems to identify DIP, we have identified another case of suspected DIP. In this study, we present a case of pancreatitis 10 days after initiation of dupilumab. An evaluation for other causes was unrevealing. As dupilumab use increases, providers should be aware of this possible adverse effect.

Association of Anti-Tumor Necrosis Factor Therapy With Mortality Among Veterans With Inflammatory Bowel Disease.

Importance: Inflammatory bowel disease (IBD) is commonly treated with corticosteroids and anti-tumor necrosis factor (TNF) drugs; however, medications have well-described adverse effects. Prior work suggests that anti-TNF therapy may reduce all-cause mortality compared with prolonged corticosteroid use among Medicare and Medicaid beneficiaries with IBD. Objective: To examine the association between use of anti-TNF or corticosteroids and all-cause mortality in a national cohort of veterans with IBD. Design, Setting, and Participants: This cohort study used a well-established Veteran's Health Administration cohort of 2997 patients with IBD treated with prolonged corticosteroids (≥3000-mg prednisone equivalent and/or ≥600 mg of budesonide within a 12-month period) and/or new anti-TNF therapy from January 1, 2006, to October 1, 2015. Data were analyzed between July 1, 2019, and December 31, 2020. Exposures: Use of corticosteroids or anti-TNF. Main Outcomes and Measures: The primary end point was all-cause mortality as defined by the Veterans Health Administration vital status file. Marginal structural modeling was used to compare associations between anti-TNF therapy or corticosteroid use and all-cause mortality. Results: A total of 2997 patients (2725 men [90.9%]; mean [SD] age, 50.0 [17.4] years) were included in the final analysis, 1734 (57.9%) with Crohn disease (CD) and 1263 (42.1%) with ulcerative colitis (UC). All-cause mortality was 8.5% (n = 256) over a mean (SD) of 3.9 (2.3) years' follow-up. At cohort entry, 1836 patients were new anti-TNF therapy users, and 1161 were prolonged corticosteroid users. Anti-TNF therapy use was associated with a lower likelihood of mortality for CD (odds ratio [OR], 0.54; 95% CI, 0.31-0.93) but not for UC (OR, 0.33; 95% CI, 0.10-1.10). In a sensitivity analysis adjusting prolonged corticosteroid users to include patients receiving corticosteroids within 90 to 270 days after initiation of anti-TNF therapy, the OR for UC was statistically significant, at 0.33 (95% CI, 0.13-0.84), and the OR for CD was 0.55 (95% CI, 0.33-0.92). Conclusions and Relevance: This study suggests that anti-TNF therapy may be associated with reduced mortality compared with long-term corticosteroid use among veterans with CD, and potentially among those with UC.

The Association of Medications and Vaccination with Risk of Pneumonia in Inflammatory Bowel Disease.

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at increased risk for pneumonia, and corticosteroids are reported to amplify this risk. Less is known about the impact of corticosteroid-sparing IBD therapies on pneumonia risk or the efficacy of pneumococcal vaccination in reducing all-cause pneumonia in real-world IBD cohorts. METHODS: We performed a population-based study using an established Veterans Health Administration cohort of 29,957 IBD patients. We identified all patients who developed bacterial pneumonia. Cox survival analysis was used to determine the association of corticosteroids at study entry and as a time-varying covariate, corticosteroid-sparing agents (immunomodulators and antitumor necrosis-alpha [TNF] inhibitors), and pneumococcal vaccination with the development of all-cause pneumonia. RESULTS: Patients with IBD who received corticosteroids had a greater risk of pneumonia when controlling for age, gender, and comorbidities (hazard ratio [HR] 2.21; 95% confidence interval [CI], 1.90-2.57 for prior use; HR = 3.42; 95% CI, 2.92-4.01 for use during follow-up). Anti-TNF inhibitors (HR 1.52; 95% CI, 1.02-2.26), but not immunomodulators (HR 0.91; 95% CI, 0.77-1.07), were associated with a small increase in pneumonia. A history of pneumonia was strongly associated with subsequent pneumonia (HR = 4.41; 95% CI, 3.70-5.27). Less than 15% of patients were vaccinated against pneumococcus, and this was not associated with a reduced risk of pneumonia (HR = 1.02; 95% CI, 0.80-1.30) in this cohort. CONCLUSION: In a large US cohort, corticosteroids were confirmed to increase pneumonia risk. Tumor necrosis-alpha inhibitors were associated with a smaller increase in the risk of pneumonia. Surprisingly, pneumococcal vaccination did not reduce all-cause pneumonia in this population, though few patients were vaccinated.

The Incidence and Prevalence of Anxiety, Depression, and Post-traumatic Stress Disorder in a National Cohort of US Veterans With Inflammatory Bowel Disease.

BACKGROUND: Patients with inflammatory bowel disease (IBD) are more susceptible to mental health problems than the general population; however, temporal trends in psychiatric diagnoses' incidence or prevalence in the United States are lacking. We sought to identify these trends among patients with IBD using national Veterans Heath Administration data. METHODS: We ascertained the presence of anxiety, depression, or posttraumatic stress disorder among veterans with IBD (ulcerative colitis or Crohn's disease) during fiscal years 2000-2015. Patients with prior anxiety, depression, or posttraumatic stress disorder before their first Veterans Health Administration IBD encounter were excluded to form the study cohort. We calculated annual prevalence, incidence rates, and age standardized and stratified by gender using a direct standardization method. RESULTS: We identified 60,086 IBD patients (93.9% male). The prevalence of anxiety, depression, and/or posttraumatic stress disorder increased from 10.8 per 100 with IBD in 2001 to 38 per 100 with IBD in 2015; 19,595 (32.6%) patients had a new anxiety, depression, and/or posttraumatic stress disorder diagnosis during the study period. The annual incidence rates of these mental health problems went from 6.1 per 100 with IBD in 2001 to 3.6 per 100 in 2015. This trend was largely driven by decline in depression. CONCLUSIONS: The prevalence of anxiety, depression, and posttraumatic stress disorder is high among US veterans with IBD and increasing, given the chronicity of IBD and psychological diagnoses. Incidence, particularly depression, appears to be declining. Confirmation and reasons for this encouraging trend are needed.

Incidence and predictors of new persistent opioid use following inflammatory bowel disease flares treated with oral corticosteroids.

BACKGROUND: Opioids are commonly prescribed to manage pain associated with inflammatory bowel disease (IBD). It is unknown what percentage of patients develop new persistent opioid use following a steroid-treated IBD flare. AIM: To identify the incidence and the predictors of new persistent opioid use following an IBD flare. METHODS: We used a national insurance claim dataset to identify patients with IBD who received an opioid medication around the time of a corticosteroid-treated IBD flare. Patients were stratified as previously opioid naïve, intermittent users, or chronic users. The incidence of persistent opioid use among the opioid-naïve cohort was evaluated along with associated predictors. RESULTS: We identified 15 119 IBD patients who received opioids around the time of a flare. 5411 (35.8%) were opioid-naïve patients of which 35.0% developed persistent opioid use after the flare. Factors associated with new persistent opioid use include a history of depression (hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.13-1.47), substance abuse (HR 1.36, 95% CI 1.2-1.54), chronic obstructive pulmonary disease (COPD) (HR 1.17, 95% CI 1.04-1.3), as well as, Crohn's disease (HR 1.26, 95% CI 1.14-1.4) or indeterminate colitis (HR 1.6, 95% CI 1.36-1.88). CONCLUSIONS: New persistent opioid use is common in IBD patients who experience a flare, especially among those with mental health disorders, COPD, and Crohn's disease or indeterminate colitis. These findings can be helpful in risk-stratifying patients when choosing an acute pain therapy and providing counselling before choosing to prescribe opioids to opioid-naïve patients experiencing an IBD flare.

CT utilization abruptly increases at age 18 among patients with inflammatory bowel diseases in the hospital.

OBJECTIVES: Patients with inflammatory bowel disease(IBD) are frequently exposed to computed tomography (CT). Each CT exposes patients to radiation that cumulatively could increase the risk of malignancy, particularly in younger patients. We aim to study the effect of age on CT use in IBD patients seen in the Emergency Department (ED) or the hospital. METHODS: We conducted a retrospective cohort study of IBD patients identified in Truven Health Marketscan databases between 2009-2013. The main outcome was use of CT during an ED or inpatient visit. Effect of age on CT use was characterized using logistic regression accounting for important covariables. RESULTS: There were 66,731 patients with IBD with 144,147 ED or inpatient visits in this cohort with a diagnosis code of IBD. At first visit, 5.8% percent were below age 18. CT was utilized in 26.6% of visits. In multivariable analysis, adjusting for medications, recent surgery, and gender, patients 18-35 were more likely to undergo CT (OR 2.35, 95%CI: 2.20-2.52) compared to those <18. Examining patients only between 16 and 19, the odds of an 18 or 19-year-old undergoing CT is significantly higher than a 16 or 17-year-old (OR 1.96, 95%CI: 1.71-2.24). CONCLUSIONS: Patients with IBD undergo CT more than a quarter of the time in the ED or inpatient setting. Pediatric providers limit radiation exposure among those <18 while adult providers are not as cautious with radiation exposure for the young adult population. Increased awareness of the risks of cumulative radiation exposure in the young adult population is needed.

Predicting Corticosteroid-Free Biologic Remission with Vedolizumab in Crohn's Disease.

Background and Aims: Vedolizumab (VDZ) is effective for Crohn's disease (CD) but costly and is slow to produce remission. Early knowledge of whether vedolizumab is likely to succeed is valuable for physicians, patients, and insurers. Methods: Phase 3 clinical trial data on VZD for CD were used to predict outcomes. Random forest modeling on the training cohort was used to predict the outcome of corticosteroid-free biologic remission at week 52 on the testing cohort. Models were constructed using baseline data, or data through week 6 of VDZ therapy. Results: The clinical trial included 594 subjects who received VDZ with baseline active inflammation [elevated C-reactive protein (>5 mg/L)]. Subjects with missing predictor variables (N = 120) or missing outcome data (N = 2) were excluded to produce a modeling dataset of 472 subjects. The Area Under the Receiver Operating Characteristic curve (AuROC) for corticosteroid-free biologic remission at week 52 using baseline data was only 0.65 (95% CI: 0.53 - 0.77), but was 0.75 (95% CI: 0.64 - 0.86) with data through week 6 of VDZ . Patients predicted to be in corticosteroid-free biologic remission at week 52 by the model achieved this endpoint 35.8% of the time, whereas patients predicted to fail only succeeded 6.7% of the time. Conclusions: An algorithm using laboratory data through week 6 of VDZ therapy was able to identify which CD patients with baseline inflammation would achieve corticosteroid-free biologic remission on VDZ at week 52. A majority of patients can be identified by week 6 as very unlikely to achieve remission.