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Older Adults Are at Higher Risk for Developing Anti-TNF Antibodies [Meeting Abstract]

Faye, A; Hong, S; Axelrad, J; Katz, S; Hudesman, D; Dervieux, T
Introduction: As the inflammatory bowel disease (IBD) patient population ages, there will be an increasing number of individuals requiring advanced therapies. Although older age is thought to be associated with immunosenescence, there are data suggesting that older adults may be at higher risk for antibody development as the result of biologic use.
Method(s): Using a large commercial laboratory database (Prometheus Laboratories), we extracted infliximab (IFX) dosing as well as antibody to infliximab (ATI) levels for all individuals using this assay from 2015-2021. Our primary outcome was the presence of ATI (titer >3.1 U/mL). Frequencies were recorded as categorical variables with chi-square analysis used, and multivariable logistic regression was employed to assess the impact of IFX dose, age (< 60 years-old v. >=60 years-old), and IBD subtype on the development of ATI.
Result(s): Overall, there were 22,197 unique specimens, with 3,028 (13.6%) having ATI. When stratified by age, individuals >=60 years-old developed ATI 18.1% (473/2,612) of the time as compared to 15.0% (2,555/17,030) for individuals < 60 years of age (p< 0.01, Figure). Among all individuals with IFX dose < 10mg q8 weeks, older adults (>=60 years of age) were more likely to develop ATI as compared to younger adults (22.8% vs. 16.2%, respectively, p< 0.01); however, when IFX dose was >=10mg/kg q8 weeks, age >= 60 years-old was no longer significantly associated with the development of ATI (9.9% if < 60 years-old vs. 10.6% if >=60 years-old) on univariable analysis. Overall, older adults were less likely to receive IFX doses >=10mg/kg q8 weeks (38.4% in older adults vs. 49.7% in younger adults; p< 0.01). On multivariable analysis, age >=60 years-old (adjOR 1.35, 95%CI 1.20-1.51), IFX dose >= 10mg/kg q8 weeks (adjOR 0.53, 95%CI 0.49-0.57) and having ulcerative colitis as compared to Crohn's disease (adjOR 1.44, 95%CI 1.33-1.57) were independently associated with the development of ATI.
Conclusion(s): Older adults with IBD develop ATI more frequently than younger adults when adjusting for IFX dose and IBD subtype. However, when IFX dose >=10mg/kg q8 weeks, ATI was significantly less likely to develop among older adults, and occurred in a similar proportion of younger individuals. Further education is needed, highlighting that older adults with IBD are more likely to develop ATI as compared to younger adults, particularly when using lower doses of IFX, and that higher doses may decrease this likelihood. (Figure Presented)
EMBASE:641286800
ISSN: 1572-0241
CID: 5515012

Cost-Effectiveness of Endoscopic Stricturotomy versus Resection Surgery for Crohn's Disease Strictures [Meeting Abstract]

Lee, K E; Lim, F; Faye, A; Hur, C; Shen, B
Introduction: Strictures in Crohn's disease (CD) increase the likelihood of requiring surgery, which is costly and invasive. In the last two decades, endoscopic therapies including endoscopic balloon dilation (EBD) and endoscopic stricturotomy (ESt) have emerged as effective and less invasive therapies for CD strictures.1 ESt in particular is advantageous for longer, fibrotic strictures, or strictures adjacent to anatomic structures requiring precision, and has shown a high rate of surgery-free survival.2-4 We therefore assessed the cost-effectiveness of ESt as compared to surgical resection for CD strictures.
Method(s): A microsimulation state-transition model compared ESt to surgical resection for patients with primary or anastomotic CD strictures. Our primary outcome was quality-adjusted life years (QALYs) over ten years, and strategies were compared at a willingness to pay (WTP) of $100,000/QALY from a societal perspective. Costs (2022 $US) and ICERs were calculated. Deterministic 1-way and probabilistic analyses assessed model uncertainty.
Result(s): The surgery strategy cost more than 2.5 times the endoscopic stricturotomy strategy, but resulted in nine higher QALYs per 100 persons (Table). Overall, surgery had an ICER of $308,787/QALY, making ESt more cost-effective. The median number of endoscopic stricturotomies was 4 in the ESt strategy and 0 in the surgery strategy; the median number of surgeries was 0 and 2 respectively. One-way sensitivity analyses showed that quality of life after ESt as compared to that after surgery, probabilities of requiring repeated interventions, and surgical mortality and cost were the most influential parameters in our model (Figure). Probabilistic sensitivity analyses favored ESt in 65.5% of iterations.
Conclusion(s): Endoscopic stricturotomy is cost-effective for managing primary or anastomotic Crohn's disease strictures. Post-intervention quality of life and probabilities of requiring repeated interventions exert most influence on cost-effectiveness; the decision between ESt and surgery should be made considering patients' risk and quality of life preferences. (Figure Presented)
EMBASE:641284829
ISSN: 1572-0241
CID: 5515252

Risk of Postpartum Flare Hospitalizations in Patients with Inflammatory Bowel Disease Persists After Six Months

Wen, Timothy; Faye, Adam S; Lee, Kate E; Friedman, Alexander M; Wright, Jason D; Lebwohl, Benjamin; Colombel, Jean-Frederic
BACKGROUND:Although patients with IBD are at higher risk for flares during the postpartum period, little is known about the risk factors, timeline, and healthcare-associated costs of a readmission flare. AIMS/OBJECTIVE:To ascertain the timeline in which patients are hospitalized for postpartum inflammatory bowel disease (IBD) flares, and the associated risk factors. METHODS:This is a nationwide retrospective cohort study of 7054 patients with IBD who delivered between 2010-2014 obtained from the National Readmissions Database. The presence of IBD was defined using previously validated International Classification of Diseases codes, and univariable and multivariable regression models were performed to assess risk factors associated with a postpartum flare hospitalization over the nine-month observation period. RESULTS:A total of 353 (5.0%) patients were hospitalized for a postpartum IBD flare, with approximately one-third (30.0%) readmitted after 6 months. On multivariable analysis, having Crohn's disease (aRR 1.47, 95%CI 1.16-1.88), Medicare insurance (aRR 3.30, 95%CI 2.16-5.02), and ≥ 2 comorbidities (aRR 1.34, 95%CI 1.03-1.74) were independently associated with a higher risk of an IBD flare hospitalization. Compared to patients aged 25-29, those 20-24 were at higher risk for an IBD flare readmission (aRR 1.58, 95%CI 1.17-2.13), whereas patients aged 35-39 years were at lower risk (aRR 0.63, 95%CI 0.43-0.92). CONCLUSIONS:Among patients with IBD, Crohn's disease, Medicare insurance, multiple comorbidities, and younger age were independent risk factors for a postpartum IBD flare hospitalization. As approximately one-third of these readmissions occurred after 6 months, it is imperative to ensure adequate follow-up and treatment for postpartum IBD patients, particularly in the extended postpartum period.
PMID: 33932199
ISSN: 1573-2568
CID: 4959582

Cancer in Inflammatory Bowel Disease

Faye, Adam S; Holmer, Ariela K; Axelrad, Jordan E
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.
PMID: 36153115
ISSN: 1558-1942
CID: 5333222

Sarcopenia in Inflammatory Bowel Diseases: Reviewing Past Work to Pave the Path for the Future

Faye, Adam S; Khan, Tasnin; Cautha, Sandhya; Kochar, Bharati
PURPOSE OF THE REVIEW/UNASSIGNED:Sarcopenia is the loss of muscle quantity and strength. It is highly prevalent in patients with inflammatory bowel disease (IBD) and is associated with periods of ongoing inflammation. This review will summarize the prior work in the field and highlight areas for future research. RECENT FINDINGS/UNASSIGNED:The presence of sarcopenia has been associated with adverse outcomes in different populations. Most recently, sarcopenia has been associated with adverse postoperative outcomes and an increased likelihood of surgery in IBD. Despite this, significant heterogeneity among these studies limits the ability to draw definitive conclusions. SUMMARY/UNASSIGNED:The importance of sarcopenia in inflammatory bowel disease (IBD) is only beginning to be recognized. Future studies assessing it utility both as a risk stratification tool and a modifiable factor in IBD are needed.
PMCID:9648863
PMID: 36388172
ISSN: 1092-8472
CID: 5384862

Cost-effectiveness of Venous Thromboembolism Prophylaxis After Hospitalization in Patients With Inflammatory Bowel Disease

Lee, Kate E; Lim, Francesca; Colombel, Jean-Frederic; Hur, Chin; Faye, Adam S
BACKGROUND:Patients with inflammatory bowel disease (IBD) have a 2- to 3-fold greater risk of venous thromboembolism (VTE) than patients without IBD, with increased risk during hospitalization that persists postdischarge. We determined the cost-effectiveness of postdischarge VTE prophylaxis among hospitalized patients with IBD. METHODS:A decision tree compared inpatient prophylaxis alone vs 4 weeks of postdischarge VTE prophylaxis with 10 mg/day of rivaroxaban. Our primary outcome was quality-adjusted life years (QALYs) over 1 year, and strategies were compared using a willingness to pay of $100,000/QALY from a societal perspective. Costs (in 2020 $USD), incremental cost-effectiveness ratios (ICERs) and number needed to treat (NNT) to prevent 1 VTE and VTE death were calculated. Deterministic 1-way and probabilistic analyses assessed model uncertainty. RESULTS:Prophylaxis with rivaroxaban resulted in 1.68-higher QALYs per 1000 persons compared with no postdischarge prophylaxis at an incremental cost of $185,778 per QALY. The NNT to prevent a single VTE was 78, whereas the NNT to prevent a single VTE-related death was 3190. One-way sensitivity analyses showed that higher VTE risk >4.5% and decreased cost of rivaroxaban ≤$280 can reduce the ICER to <$100,000/QALY. Probabilistic sensitivity analyses favored prophylaxis in 28.9% of iterations. CONCLUSIONS:Four weeks of postdischarge VTE prophylaxis results in higher QALYs compared with inpatient prophylaxis alone and prevents 1 postdischarge VTE among 78 patients with IBD. Although postdischarge VTE prophylaxis for all patients with IBD is not cost-effective, it should be considered in a case-by-case scenario, considering VTE risk profile, costs, and patient preference.
PMID: 34591970
ISSN: 1536-4844
CID: 5287502

Prevalence of Extensive and Limited Gastric Intestinal Metaplasia and Progression to Dysplasia and Gastric Cancer

Laszkowska, Monika; Truong, Han; Faye, Adam S; Kim, Judith; Tan, Sarah Xinhui; Lim, Francesca; Abrams, Julian A; Hur, Chin
BACKGROUND AND AIMS/OBJECTIVE:Guidelines cite extensive gastric intestinal metaplasia (GIM) as a bigger risk factor for gastric cancer (GC) than limited GIM and an indication for endoscopic surveillance. Data on progression of extensive GIM to GC in the USA are limited. This study aimed to estimate the prevalence and progression rates of extensive GIM in a US cohort. METHODS:This retrospective study assessed the prevalence of extensive GIM between 1/1/1990 and 8/1/2019 at a large academic medical center. Multivariable regression was used to identify predictors of extensive GIM. Incidence of GC on follow-up was calculated as number of new diagnoses divided by person-years of follow-up. Presence of GIM on subsequent follow-up endoscopy was assessed. RESULTS:Of 1256 individuals with GIM, 352 (28%) had extensive GIM and 904 (72%) had limited GIM. On multivariable analysis, older age (OR 1.01, 95% CI 1.00-1.02) and Hispanic ethnicity (OR 1.55, 95% CI 1.11-2.16) were predictive of extensive GIM. The annual incidence of GC for GIM overall was 0.09%. There was no difference in progression to GC between extensive or limited GIM (IRR 0, 95% CI 0-2.6), or to advanced lesions overall (IRR 0.37, 95% CI 0.04-1.62). 70% of individuals had persistent GIM on follow-up biopsy, and 22% with limited GIM had extensive GIM on follow-up biopsy. CONCLUSIONS:28% of individuals with GIM have the extensive subtype, and are more likely to be older and of Hispanic ethnicity. There was no difference in progression to GC between extensive and limited GIM. Further research is needed to better assess risk of GIM in the US context.
PMID: 34657192
ISSN: 1573-2568
CID: 5043042

Colorectal Strictures in Patients With Inflammatory Bowel Disease Do Not Independently Predict Colorectal Neoplasia

Axelrad, Jordan E; Faye, Adam; Slaughter, James C; Harpaz, Noam; Itzkowitz, Steven H; Shah, Shailja C
BACKGROUND:Colorectal strictures have been considered independent risk factors for neoplasia in patients with inflammatory bowel disease (IBD). We examined the association between colorectal stricture and subsequent risk of colorectal neoplasia (CRN) in patients with IBD colitis undergoing colonoscopic surveillance. METHODS:We conducted a retrospective cohort analysis of patients with IBD colitis enrolled in colonoscopic surveillance for CRN at an academic medical center between 2005 and 2017. Inclusion criteria were IBD involving the colon for ≥8 years (or any duration with primary sclerosing cholangitis [PSC]) undergoing surveillance. Exclusion criteria were advanced CRN (ACRN; colorectal cancer [CRC] or high-grade dysplasia [HGD]) prior to or at enrollment, prior colectomy, or limited (<30%) disease extent or proctitis. Multivariable logistic and Cox regression analysis estimated the association between colorectal stricture on the index colonoscopy and ACRN, CRN (indefinite dysplasia, low-grade dysplasia, HGD, CRC), or colectomy. RESULTS:Among 789 patients with IBD undergoing CRC surveillance, 72 (9%; 70 with Crohn's colitis) had a colorectal stricture on index colonoscopy. There was no significant difference in the frequency of ACRN or requirement for colectomy between patients with vs without a colorectal stricture (P > .05). Colorectal stricture was not associated with subsequent ACRN (adjusted odds ratio [aOR], 1.41; 95% CI, 0.49-4.07), CRN (aOR, 1.15; 95% CI, 0.51-2.58), or colectomy (aOR, 1.10; 95% CI, 0.65-1.84). CONCLUSIONS:In this analysis of patients with IBD colitis undergoing CRN surveillance, the presence of a colorectal stricture was not independently associated with risk of ACRN or colectomy. Multicenter, prospective studies are needed to confirm these findings, particularly in patients with ulcerative colitis-associated colorectal stricture.
PMID: 34319381
ISSN: 1536-4844
CID: 4949732

Outcomes during delivery hospitalisations with inflammatory bowel disease

Yu, K; Faye, A S; Wen, T; Guglielminotti, J R; Huang, Y; Wright, J D; D'Alton, M E; Friedman, A M
OBJECTIVE:To characterise inflammatory bowel disease (IBD) trends and associated risk during delivery hospitalisations. DESIGN/METHODS:Cross-sectional. SETTING/METHODS:US delivery hospitalisations. POPULATION/METHODS:Delivery hospitalisations in the 2000-2018 National Inpatient Sample. METHODS:This study analysed a nationally representative hospital discharge database based on the presence of IBD. Temporal trends in IBD were analysed using joinpoint regression to estimate the average annual percent change (AAPC). IBD severity was characterised by the presence of diagnoses such as penetrating and stricturing disease and history of bowel resection. Risks for adverse outcomes were analysed based on presence of IBD. Poisson regression models were performed with unadjusted and adjusted risk ratios (aRR) as measures of effect. MAIN OUTCOME MEASURE/METHODS:Prevalence of IBD and associated adverse outcomes. RESULTS:Of 73 109 790 delivery hospitalisations, 89 965 had a diagnosis of IBD. IBD rose from 0.06% in 2000 to 0.21% in 2018 (AAPC 7.3%, 95% CI 6.7-7.9%). Among deliveries with IBD, IBD severity diagnoses increased from 4.1% to 8.1% from 2000 to 2018. In adjusted analysis, IBD was associated with increased risk for preterm delivery (aRR 1.50, 95% CI 1.47-1.53), severe maternal morbidity (aRR 1.93, 95% CI 1.83-2.04), venous thrombo-embolism (aRR 2.76, 95% CI 2.39-3.18) and surgical injury during caesarean delivery hospitalisation (aRR 5.03, 95% CI 4.76-5.31). In the presence of a severe IBD diagnosis, risk was further increased for all adverse outcomes. CONCLUSION/CONCLUSIONS:IBD is increasing in the obstetric population and is associated with adverse outcomes. Risk is increased in the presence of a severe IBD diagnosis. TWEETABLE ABSTRACT/UNASSIGNED:Deliveries among women with inflammatory bowel disease are increasing. Disease severity is associated with adverse outcomes.
PMID: 35152548
ISSN: 1471-0528
CID: 5163322

Editorial: safety in numbers-cycling of biologics does not increase risk of adverse outcomes [Editorial]

Faye, Adam S; Axelrad, Jordan E
PMCID:9102742
PMID: 35538352
ISSN: 1365-2036
CID: 5214362