AudioAbstracts

Host: Abdullah Abdussalam, MD

Proactive Vs Reactive Therapeutic Drug Monitoring of Infliximab in Crohn’s

Diana M Negoescu, Eva A Enns, PhD, Brooke Swanhorst, Bonnie Baumgartner, James P Campbell, Mark T Osterman, MD, Konstantinos Papamichael, PhD, Adam S Cheifetz, MD, Byron P Vaughn, MD

Background: Therapeutic drug monitoring (TDM) is increasingly performed for Infliximab (IFX) in patients with Crohn's disease (CD). Reactive TDM is a cost-effective strategy to empiric IFX dose escalation. The cost-effectiveness of proactive TDM is unknown. The aim of this study is to assess the cost-effectiveness of proactive vs reactive TDM in a simulated population of CD patients on IFX.

Methods: We developed a stochastic simulation model of CD patients on IFX and evaluated the expected health costs and outcomes of a proactive TDM strategy compared with a reactive strategy. The proactive strategy measured IFX concentration and antibody status every 6 months, or at the time of a flare, and dosed IFX to a therapeutic window. The reactive strategy only did so at the time of a flare.

Results: The proactive strategy led to fewer flares than the …

Guest: Juan Ochoa, MD

Join Dr. Juan Ochoa, Medical Director of Surgical Intensive Care at Oschsner Medical Center, as he reviews a retrospective study that investigated the impacts of high-protein, low-calorie feedings on critically ill patients in the ICU. Dr. Ochoa is a Surgeon, physician scientist, and former Chief Medical Officer of Nestlé Health Science.

Guest: Anish Patel, DO, FACG

Real-world Pattern of Biologic Use in Patients With Inflammatory Bowel Disease: Treatment Persistence, Switching, and Importance of Concurrent Immunosuppressive Therapy

Chao Chen, PhD, Abraham G Hartzema, PhD, Hong Xiao, PhD, Yu-Jung Wei, PhD, Naueen Chaudhry, MD, Ofor Ewelukwa, MD, Sarah C Glover, DO, Ellen M Zimmermann, MD

BACKGROUND AND AIMS:
Medication persistence, defined as the time from drug initiation to discontinuation of therapy, has been suggested as a proxy for real-world therapeutic benefit and safety. This study seeks to compare the persistence of biologic drugs among patients with inflammatory bowel disease (IBD).

METHODS:
Patients with newly diagnosed IBD were included in a retrospective study using Truven MarketScan database. Treatment persistence and switching was compared among biologic medications including infliximab, adalimumab, certolizumab, golimumab, and vedolizumab. Predictors for discontinuation and switching were evaluated using time-dependent proportional hazard regression.

RESULTS:
In total, 5612 patients with Crohn's disease (CD) and 3533 patients with ulcerative colitis (UC) were included in this analysis. Less than half of the patients continued using their initial biologic treatment after 1 year (48.48% in CD cohort; 44.78% in UC cohort). …

Guest: Robin Dalal, MD

Improving the Quality of Inpatient Ulcerative Colitis Management: Promoting Evidence-Based Practice and Reducing Care Variation With an Inpatient Protocol

Sara M Lewin, MD, Ryan A McConnell, MD, Roshan Patel, MD, Suzanne R Sharpton, MD, MAS, Fernando Velayos, MD, MPH, Uma Mahadevan, MD

BACKGROUND:
Hospitalization for ulcerative colitis is a high-risk period associated with increased risk of Clostridium difficile infection, thromboembolism, and opiate use. The study aim was to develop and implement a quality-improvement intervention for inpatient ulcerative colitis management that standardizes gastroenterology consultant recommendations and improves delivery of evidence-based care.

METHODS:
All adult patients hospitalized for ulcerative colitis between July 1, 2014, and December 31, 2017, who received intravenous corticosteroids were included. On July 1, 2016, the UCSF Inpatient Ulcerative Colitis Protocol was implemented, featuring standardized core recommendations and a daily checklist for gastroenterology consultant notes, a bundled IBD electronic order set, and an opiate awareness campaign. The composite primary outcome was adherence to all 3 evidence-based care metrics: C. difficile testing performed, pharmacologic venous thromboembolism (VTE) prophylaxis ordered, and opiates avoided.

RESULTS:
Ninety-three ulcerative colitis hospitalizations occurred, including 36 preintervention and 57 postintervention. Age, gender, …

Results of an Expert Consensus Survey on the Treatment of Pulmonary Arterial Hypertension with Oral Prostacyclin Pathway Agents

Vallerie V McLaughlin, MD, FACC, FCCP; Richard Channick, MD; Teresa De Marco, MD, FACC, FHFSA; Harrison W Farber, MD, FCCP; Sean Gaine, MD, PhD; Nazzareno Galié, MD; Richard A Krasuski, MD; Ioana Preston, MD; Rogerio Souza, MD, PhD; J Gerry Coghlan, MD; Robert P. Frantz, MD; Anna Hemnes, MD; Nick H Kim, MD; Irene M Lang, MD; David Langleben, MD; Mengtao Li, MD; Olivier Sitbon MD, PhD; Victor Tapson, MD; Adaani Frost, MD

Funding was provided by Actelion to support the use of independent providers of Delphi methodology expertise and nominal group technique, survey creation, data analysis, medical communication, and meeting management. The authors were not paid an honorarium for their participation. Actelion played no role in the literature search and analysis, development of surveys used to gather consensus, or data analysis; and no Actelion employee was present at the meeting during which consensus statements were finalized. The manuscript was drafted, critically reviewed, and edited solely by the authors with support from an independent professional medical communications agency. Actelion Pharmaceuticals reviewed the final manuscript only to ensure accuracy of UPTRAVI® (selexipag) background ...

Multicenter Clinical Validation of the Molecular-Based BD MAX™ Enteric Viral Panel for the Detection of Enteric Pathogens.

William Stokes, MD, Patricia J. Simner, MSc, PhD, Joel Mortensen, PhD, Margret Oethinger, MD, PhD, Kathleen Stellrecht, PhD, Elizabeth Lockamy, PhD, Tricia Lay, MS, Peggy Bouchy, PhD, Dylan Pillai, MD, PhD

Background:

Conventional methodology for gastrointestinal pathogens remains time-consuming, expensive, and of limited sensitivity.

Objective:

Performance evaluation of the BD MAX™ Enteric Viral Panel (MAX EVP) assay for identification of viral pathogens in stool specimens from individuals with symptoms of acute gastroenteritis, enteritis, or colitis.

Study Design:

Prospective and archival stool specimens were collected in Cary-Blair medium or unpreserved containers from adult and pediatric patients with diarrhea. Specimens tested via the MAX EVP (on the BD MAX™ System) were compared to reference method (alternate PCR assays, followed by bi-directional sequencing). Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated.

Results:

A total of 2,239 specimens were collected, with 2,148 included for analysis. In this population, 39.6% of specimens were from outpatients, 42.1% were from patients < 21 years, and 49.7% were from females. Prevalence rates for prospective specimens were 7.3%, 4.5%, 3.5%, 2.4%, and 1.2% for norovirus, sapovirus, astrovirus, rotavirus, and ...

Host: Alka Goyal, MD

Higher Postinduction Infliximab Serum Trough Levels Are Associated With Healing of Fistulizing Perianal Crohn’s Disease in Children.

Wael El-Matary, MD, MSc Thomas D Walters, MD Hien Q Huynh, MDJennifer deBruyn, MD David R Mack, MD Kevan Jacobson, MD Mary E Sherlock, MDPeter Church, MD Eytan Wine, MD, PhD Matthew W Carroll, MD, Eric I Benchimol, MD, PhD Sally Lawrence, MD Anne M Griffiths, MD

Background:

There is some evidence in adults that higher serum infliximab (IFX) levels are needed to adequately treat fistulizing perianal Crohn's disease (CD). However, data in children are lacking. We aimed to determine postinduction serum trough IFX levels that are associated with healing of fistulizing perianal CD (PCD) at week 24.

Methods:

In a multicenter inception cohort study, consecutive children younger than age 17 years with fistulizing perianal CD treated with IFX between April 2014 and June 2017 who had serum trough IFX titers measured before the fourth infusion were included. Area under the receiver operating characteristic curve (AUROC) was calculated to determine the best cutoff to predict fistula …

Host: Louis J Cohen, MD

Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Disease: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials.

Siddharth Singh, MD, MS James Proudfoot, MS Ronghui Xu, PhDWilliam J Sandborn, MD

Background:

To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project.

Methods:

We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn’s disease activity index [CDAI]<150, Mayo Clinic Score <3); secondary outcomes were clinical response and mucosal healing. Using multivariable logistic regression analysis, we compared association between quartiles of BMI (or weight) and achieving remission, after adjusting for sex, smoking, disease activity, and concomitant prednisone or immunomodulators.

Results:

We included 575 placebo-treated patients (mean age 38 years, 51.6% males, 16% obese). Obesity was not associated with odds of achieving clinical …

Host: Damian Maseda, D.M.Sc., PhD

Iron Sequestration in Microbiota Biofilms As A Novel Strategy for Treating Inflammatory Bowel Disease.

Jean-Paul Motta, PhD Thibault Allain, PhD Luke E Green-Harrison, BScRyan A Groves, MSc Troy Feener, MSc Hena Ramay, PhD Paul L Beck, MD/PhDIan A Lewis, PhD John L Wallace, PhD Andre G Buret, PhD

ABSTRACT:

Significant alterations of intestinal microbiota and anemia are hallmarks of inflammatory bowel disease (IBD). It is widely accepted that iron is a key nutrient for pathogenic bacteria, but little is known about its impact on microbiota associated with IBD. We used a model device to grow human mucosa-associated microbiota in its physiological anaerobic biofilm phenotype. Compared to microbiota from healthy donors, microbiota from IBD patients generate biofilms ex vivo that were larger in size and cell numbers, contained higher intracellular iron concentrations, and exhibited heightened virulence in a model of human intestinal epithelia in vitro and in the nematode Caenorhabditis elegans. We also describe an unexpected iron-scavenging property for an experimental hydrogen sulfide-releasing derivative of mesalamine. The findings demonstrate that this new drug reduces the virulence of IBD microbiota biofilms through …

Guest: Yash Mittal, MD

Reliability of Measuring Ileo-Colonic Disease Activity in Crohn's Disease by Magnetic Resonance Enterography.

Vipul Jairath, MD, PhD, Ingrid Ordas, MD, PhD, Guangyong Zou, PhD, Julian Panes, MD, Jaap Stoker, MD, PhD, Stuart A Taylor, MD, Cynthia Santillan, MD, Karin Horsthuis, MD, Mark A Samaan, MD, Lisa M Shackelton, PhD, Larry W Stitt, MSc, Pieter Hindryckx, MD, PhD, Reena Khanna, MD, William J Sandborn, MD ,Geert D'Haens, MD, PhD, Brian G Feagan, MD, Barrett G Levesque, MD, and Jordi Rimola, MD, PhD

BACKGROUND:

Magnetic resonance enterography is increasingly utilized for assessment of luminal Crohn's disease activity. The Magnetic Resonance Index of Activity and the London Index are the most commonly used outcome measures in clinical trials. We assessed the reliability of these indices and several additional items.

METHODS:

A consensus process clarified scoring conventions and identified additional items based on face validity. Four experienced radiologists evaluated 50 images in triplicate, in random order, at least 1 month apart, using a central image management system. Intra- and interrater reliability were assessed by calculating and comparing intraclass correlation coefficients.

RESULTS:

Intrarater intraclass correlation coefficients (95% confidence intervals) for the Magnetic Resonance Index of Activity, London, and London "extended" indices and a visual analogue …