Faculty Bibliography

BACKGROUND/UNASSIGNED:No models predict future outcomes in inflammatory bowel disease (IBD) patients receiving maintenance infliximab therapy. We created a predictive model for unfavorable outcomes. METHODS/UNASSIGNED:Adult patients with IBD receiving maintenance infliximab therapy at 2 centers with matched serum infliximab concentrations and blinded histologic scores (Robarts Histopathologic Index [RHI]) were included. The primary endpoint was an unfavorable outcome of active objective inflammation or need for IBD-related surgery or hospitalization at 6-18 months follow-up. Internal variables were identified using univariable analyses, modeling used multivariable analysis, and performance was assessed (area under receiver-operating curve [AUC]) and externally validated. RESULTS/UNASSIGNED: = .9, vs. 2-predictor model) cohorts. CONCLUSIONS/UNASSIGNED:Using unbiased variable selection, a 2-predictor model using infliximab concentrations and histology identified IBD patients on maintenance infliximab therapy at high risk of future unfavorable outcomes. For practical applicability, infliximab concentrations alone performed similarly well.

BACKGROUND & AIMS:Safety of biologic agents is a key consideration in patients with inflammatory bowel disease (IBD) and active or recent cancer. We compared the safety of tumor necrosis factor (TNF)-α antagonists vs non-TNF biologics in patients with IBD with active or recent cancer. METHODS:We conducted a multicenter retrospective cohort study of patients with IBD and either active cancer (cohort A) or recent prior cancer (within ≤5 years; cohort B) who were treated with TNFα antagonists or non-TNF biologics after their cancer diagnosis. Primary outcomes were progression-free survival (cohort A) or recurrence-free survival (cohort B). Safety was compared using inverse probability of treatment weighting with propensity scores. RESULTS:In cohort A, of 125 patients (483.8 person-years of follow-up evaluation) with active cancer (age, 54 ± 15 y, 75% solid-organ malignancy), 10 of 55 (incidence rate [IR] per 100 py, 4.4) and 9 of 40 (IR, 10.4) patients treated with TNFα antagonists and non-TNF biologics had cancer progression, respectively. There was no difference in the risk of progression-free survival between TNFα antagonists vs non-TNF biologics (hazard ratio, 0.76; 95% CI, 0.25-2.30). In cohort B, of 170 patients (513 person-years of follow-up evaluation) with recent prior cancer (age, 53 ± 15 y, 84% solid-organ malignancy; duration of remission, 19 ± 19 mo), 8 of 78 (IR, 3.4) and 5 of 66 (IR 3.7) patients treated with TNFα antagonists and non-TNF biologics had cancer recurrence, respectively. The risk of recurrence-free survival was similar between both groups (hazard ratio, 0.94; 95% CI, 0.24-3.77). CONCLUSIONS:In patients with IBD with active or recent cancer, TNFα antagonists and non-TNF biologics have comparable safety. The choice of biologic should be dictated by IBD disease severity in collaboration with an oncologist.

BACKGROUND:The Endoscopic Healing Index (EHI) is a serum biomarker panel that can predict endoscopic inflammation in Crohn's disease (CD). METHODS:Paired serum samples with endoscopies from adult patients participating in a prospective biobank (June 2014 to December 2018) were analyzed post hoc. Diagnostic performance for EHI was assessed against the individual parameters of the Simple Endoscopic Score for CD using previously identified cutoffs. Confounders for EHI performance were identified using logistic regression. RESULTS:A total of 205 CD patients were included (50% male, median age 37 years). An EHI of 20 points was sensitive for ruling out any ulcers (85%; 95% confidence interval [CI], 77%-91%) and large (5-20 mm) or very large (>20 mm) ulcers (93%; 95% CI, 84%-97%). An EHI of 50 points was specific for ruling in any ulcers (86%; 95% CI, 76%-92%) and large or very large ulcers (87%; 95% CI, 79%-92%). After accounting for total extent of inflamed mucosa, strictures, and disease location, each 20-point increase in EHI was associated with a 1.7-fold increased probability for the presence of large or very large ulcers (adjusted odds ratio, 1.7; 95% CI, 1.1-2.6). CONCLUSIONS:The EHI was independently associated with ulcer size and accurately identified large or very large ulcers. A cutoff of 50 points can reliably rule in mucosal ulcers and allow for treatment adjustment. A cutoff of 20 points can reliably rule out mucosal ulcers and signal completion of treatment adjustment algorithms.

BACKGROUND/UNASSIGNED:The COVID-19 pandemic led to the urgent implementation of telehealth visits in inflammatory bowel disease (IBD) care; however, data assessing feasibility remain limited. OBJECTIVES/UNASSIGNED:We looked to determine the completion rate of telehealth appointments for adults with IBD, as well as to evaluate demographic, clinical, and social predictors of incomplete appointments. DESIGN/UNASSIGNED:We conducted a retrospective analysis of all patients with IBD who had at least one scheduled telehealth visit at the NYU IBD Center between 1 March 2020 and 31 August 2021, with only the first scheduled telehealth appointment considered. METHODS/UNASSIGNED:Medical records were parsed for relevant covariables, and multivariable logistic regression was used to estimate the adjusted association between demographic factors and an incomplete telehealth appointment. RESULTS/UNASSIGNED: = 0.22). After adjustment, patients with CD had higher odds of an incomplete appointment as compared to patients with UC [adjusted odds ratio (adjOR): 1.37, 95% confidence interval (CI): 1.10-1.69], as did females (adjOR: 1.26, 95% CI: 1.04-1.54), and patients who had a non-first-degree relative listed as an emergency contact (adjOR: 1.69, 95% CI: 1.16-2.44). While age ⩾60 years was not associated with appointment completion status, we did find that age >80 years was an independent predictor of missed telehealth appointments (adjOR: 2.92, 95% CI: 1.12-7.63) when compared to individuals aged 60-70 years. CONCLUSION/UNASSIGNED:telehealth, particularly those aged 60-80 years, may therefore provide an additional venue to complement in-person care.

Introduction: Infliximab (IFX) has been efficacious in reducing colectomy rates among patients with moderate-to severe ulcerative colitis, but predictors of colectomy within 30 days of IFX among patients with acute severe ulcerative colitis (ASUC) are less established.
Method(s): We performed a single-center retrospective analysis of patients who received at least one dose of IFX while admitted between 2011-2022. We assessed demographic, clinical and laboratory predictors of colectomy within 30 days of first IFX dose. Multivariable and time-to-event analysis using Kaplan-Meier with log-rank statistics were used to assess risk factors for colectomy within 30 days.
Result(s): A majority of the 172 patients hospitalized with ASUC who received IFX received 10 mg/kg (87.79%). Overall, 22/172 patients (12.79%) underwent colectomy within 30 days of first IFX dose. On univariable analysis, age, sex, race, ethnicity, BMI and smoking status were not associated with risk of colectomy. Higher initial CRP was significantly associated with 30-day risk of colectomy (106.17 vs. 65.10 mg/dL among patients who did not undergo colectomy; p< 0.01), as was a decrease of CRP <=50% prior to discharge (p< 0.01). Lower initial albumin [< 3 (36.36%), 3.0-3.5 (40.91%), >3.5 g/dL (22.73%)] was associated with our primary outcome (p=0.046), as was a higher number of bowel movements in a 24-hour period prior to discharge (5.6 vs. 3.9 among patients who did not undergo colectomy; p=0.0256). On multivariable analysis, higher initial CRP (aOR 1.01, 95% CI 1.00 - 1.02), <=50% change in CRP after first dose of IFX (aOR 9.00, 95% CI 2.43 - 33.29) and higher number of bowel movements in a 24-hour period prior to discharge (aOR 1.24, 95% CI 1.01- 1.52) remained significantly associated with risk of colectomy when adjusting for relevant covariables (Table). On Kaplan-Meier analysis, initial CRP >100 mg/ dL, albumin < 3 g/dL and change in CRP <=50% prior to discharge were significantly associated with decreased time to colectomy (Figure).
Conclusion(s): Among patients with ASUC, higher CRP, decrease of CRP <=50% and higher number of bowel movements prior to discharge were associated with increased risk of colectomy within 30-days of receiving IFX. Initial CRP >100 mg/dL, albumin < 3 g/dL and decrease of <=50% in CRP prior to discharge were associated with decreased time to colectomy. These results can identify patients at highest risk and impact clinical decision-making regarding need for and timing of colectomy in patients with ASUC receiving IFX. (Table Presented)

Inflammatory bowel diseases (IBD), including Crohn disease and ulcerative colitis, are chronic inflammatory conditions of the gastrointestinal tract. Individuals with IBD are at increased risk for several malignancies originating in the intestine, such as colorectal cancer, small bowel adenocarcinoma, intestinal lymphoma, and anal cancer. There are also several extraintestinal malignancies associated with IBD and IBD therapies, including cholangiocarcinoma, skin cancer, hematologic malignancies, genitourinary cancer, cervical cancer, and prostate cancer. The authors summarize the risk of cancer in patients with IBD, diagnosis and management of colorectal neoplasia in IBD, and management of patients with IBD and active or recent cancer.

BACKGROUND AND AIMS/OBJECTIVE:Despite increasing interest in histologic remission as a treatment target in ulcerative colitis (UC), the accuracy of histologic findings in left colon in detecting pancolonic histologic remission is unknown. METHODS:In a retrospective cohort study of patients with endoscopically active pancolitis undergoing treat-to-target interventions, we evaluated the diagnostic accuracy of left-sided (distal to splenic flexure) histologic and endoscopic findings on colonoscopy for detecting histologic and endoscopic healing elsewhere in the colon. RESULTS:Of 86 patients with moderate to severely active pancolitis who underwent 2 consecutive colonoscopies during treat-to-target interventions, 38% and 51% achieved histologic and endoscopic remission, respectively. Substantial agreement (kappa, 0.67; 95% confidence interval (CI), 0.51-0.83) was observed in histologic findings between left and right colon on follow-up colonoscopy. Histologic, and endoscopic, findings in left colon showed excellent accuracy in detecting pancolonic histologic remission (area under the curve (AUC), 0.96 [95% CI, 0.93-1.0]; misclassification rate, 5.9%), histologic normalization (AUC, 1.0, 0%), endoscopic improvement (AUC, 0.95 [0.96-1.0], 3.5%) and endoscopic remission (AUC, 0.98 [0.96-1.00], 5.8%), respectively. CONCLUSIONS:In patients with active pancolitis undergoing treat-to-target interventions, histologic and endoscopic findings in the left colon on colonoscopy have excellent accuracy for detecting pancolonic histologic remission, histologic normalization, endoscopic improvement, and endoscopic remission. Flexible sigmoidoscopy may suffice for monitoring histologic and endoscopic activity in patients with pancolitis.

Introduction: With an aging population, management of biologic therapy in IBD patients with active or recent cancer is challenging. We evaluated the comparative safety of non-tumor necrosis factor (TNF)-a directed therapy vs. TNFa antagonists vs. immunomodulator monotherapy (IMM) in IBD patients with active or recent cancer (<=5 years).
Method(s): Through the collaborative REACH-IBD (Rising Educators Academics and Clinicians Helping IBD) research initiative, we conducted a retrospective, multi-center cohort study. We included IBD patients from 12 centers with active cancer (Cohort A) or recent cancer within = years (Cohort B) who were treated with non-TNFa biologics vs. TNFa antagonists (reference) after cancer diagnosis.We excluded patients with nonmelanoma skin cancer. Primary outcomes were cancer progression (Cohort A) or new/recurrent cancer (Cohort B). We performed Cox proportional hazard analysis to compare the safety of different biologics.
Result(s): (Cohort A)We included 107 patients with active cancer (5416y, 62% male, 72% solid cancer, 400 person-year follow-up), of whom 35 were treated with non-TNFa biologics (29 vedolizumab, 6 ustekinumab), 45 with TNFa antagonists and 27 with IMM (Table 1). Overall, 19 patients had progression of cancer, 13 died and 20 were hospitalized for serious infection (Figure 1A). After adjusting for age and type of active cancer, there was no difference in the risk of cancer progression (non-TNFa biologics vs. TNFa antagonists: HR, 1.55; 95% CI, 0.48-5.03), mortality (HR, 2.74; 95% CI, 0.25-30.5) and serious infections (HR, 1.90; 95% CI, 0.15-24.0) between patients treated with non-TNFa biologics vs. TNFa antagonists. (Cohort B) We included 141 patients with recent prior cancer (5214y, 51% male, 86% solid cancer; duration of remission prior to starting biologics, 1719m) of whom 54 were treated with non-TNFa biologics (40 vedolizumab, 14 ustekinumab), 63 with TNFa antagonists and 24 with IMM (Table 1). Overall, 14 patients had recurrence of cancer (or developed new incident cancer) and 6 died (Figure 1B). After adjusting for age, type of prior cancer and duration of remission, there was no difference in the risk of cancer recurrence between non-TNFa biologics vs. TNFa antagonists (HR, 0.97; 95% CI, 0.16-5.75).
Conclusion(s): In IBD patients with active or recent cancer (within = years), non-TNFa-directed biologics and TNFa antagonists have comparable safety. Choice of biologic should be dictated by IBD disease severity, in collaboration with an oncologist