Impact of Precision-Guided Dosing on Clinical Decision-Making and Health Care Utilization in Inflammatory Bowel Disease: A Retrospective Pretest/Posttest Real-World Study.

Background: Precision-guided dosing (PGD) is a personalized tool that optimizes clinical decision-making in the treatment of inflammatory bowel disease (IBD) with infliximab (IFX) and its biosimilars. PGD employs nonlinear mixed-effect models using patient-specific pharmacokinetic parameters to predict infliximab trough concentrations without the need to wait until the actual trough measurement. This approach calculates patient-specific clearance (CL) and provides tailored IFX dosing and administration intervals aimed at achieving target trough levels.

A Guide to De-escalation of Combination Therapy in Inflammatory Bowel Disease: A Retrospective Cohort Study.

Background: Advanced combination therapy with biologics and small molecules has seen more widespread implementation for inflammatory bowel disease (IBD). However, there is a paucity of data available to guide the successful de-escalation of combination therapy following the achievement of disease remission. Therefore, we pursued this retrospective study to evaluate our center's approach to de-escalation of these patients.

The Clinical Utility of Precision-Guided Dosing for Adalimumab Therapy Optimization in Inflammatory Bowel Disease: A Clinical Experience Program.

: This study aimed to establish the clinical utility of a therapeutic drug monitoring (TDM)-supported, model-informed precision dosing (MIPD) approach (precision-guided dosing [PGD]) by assessing the impact of pharmacokinetic (clearance [CL]) and clinical laboratory parameters on adalimumab (ADA) dosage adjustments during maintenance therapy for inflammatory bowel disease (IBD). : In the EMPOWER study, blood was collected at any time post-ADA injection. Pharmacokinetic (PK) testing was conducted in an accredited lab.

Efficacy and Safety of Mirikizumab in the Treatment of Moderately to Severely Active Ulcerative Colitis Regardless of Baseline Modified Mayo Score: Results From the Phase 3 LUCENT Trials.

Background: The modified Mayo score (mMS) is a measure for ulcerative colitis (UC) disease activity. Recent US Food and Drug Administration guidance for moderately to severely active UC trials suggests that patients should have baseline mMS of 5-9 including an endoscopy score of at least 2, as opposed to the previous range of 4-9. This disclosure reports results from patients with UC with baseline mMS of 5-9 who received mirikizumab, a monoclonal antibody directed against the interleukin-23 p19 subunit, or placebo in the phase 3 LUCENT trials.

Use of Biosimilars to Infliximab During Pregnancy in Women With Inflammatory Bowel Disease: Results From the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes Study.

Introduction: We aimed to compare pregnancy outcomes of women with inflammatory bowel disease using biosimilar vs originator infliximab (IFX).

Methods: In a prospective cohort of pregnant women with inflammatory bowel disease, we collected characteristics, medications, pregnancy outcomes, and developmental milestones. We compared outcomes by IFX biosimilar or originator use via bivariate statistics.

Therapeutic Potential of Etrasimod in the Management of Moderately-to-Severely Active Ulcerative Colitis: Evidence to Date.

Etrasimod is a sphingosine 1 phosphate (S1P) receptor modulator approved for the treatment of moderate to severely active ulcerative colitis (UC). Etrasimod selectively activates S1P receptors with no detectable activity on S1P. The ELEVATE clinical trials evaluated the efficacy and safety of etrasimod for UC.

AGA Clinical Practice Update on the Role of Intestinal Ultrasound in Inflammatory Bowel Disease: Commentary.

Description: In the past 3 years, the use of intestinal ultrasound (IUS) for monitoring inflammatory bowel disease in clinical practice has grown substantially in the United States. This American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) aims to review the available evidence and guidance regarding the role of intestinal ultrasound in inflammatory bowel disease care.

Methods: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Clinical Gastroenterology and Hepatology.

Postoperative Ustekinumab Drug Levels and Disease Activity in Patients with Crohn's Disease.

Aims: This study investigated how post-operative ustekinumab levels relate to surgery type, endoscopic, biochemical, and clinical outcomes in patients with Crohn's Disease.

Methods: A retrospective study of patients with Crohn's Disease with a disease-related operation between 2016 and 2022 assessed outcomes based on ustekinumab levels. Patients were included if they had an ustekinumab trough level within two years post-operatively.

Therapeutic drug monitoring in inflammatory bowel disease patients on vedolizumab.

Objective: We aimed to investigate whether vedolizumab (VDZ) levels were associated with inflammatory markers or clinical or endoscopic scoring in inflammatory bowel disease (IBD).

Methods: Besides demographic data, clinical scoring, endoscopic data, and laboratory markers of IBD patients treated with VDZ from 2015 to 2020 who had trough levels drawn on maintenance therapy were collected at baseline and at follow-up (after at least 8 weeks on VDZ therapy or after change in dose frequency). Low drug levels were defined as VDZ trough <20 μg/mL.

Therapeutic drug monitoring in patients with inflammatory bowel disease on ustekinumab.

Objective: Therapeutic drug monitoring is used clinically to guide anti-tumor necrosis factor (TNF) therapy for inflammatory bowel disease (IBD), but its use for ustekinumab (UST) remains unclear. This study aimed to determine predictive variables of UST levels.

Methods: In this retrospective cohort of patients with IBD, UST trough levels were drawn at maintenance dosing.

Risk of Infection in Patients With Inflammatory Bowel Disease Treated With Interleukin-Targeting Agents: A Systematic Review and Meta-Analysis.

Background: Patients with inflammatory bowel disease (IBD) are at increased risk of infection. The aim of this study was to assess the cumulative incidence and risk of infection in patients with IBD treated with interleukin (IL)-targeting agents.

Methods: We searched PubMed, EMBASE, and Web of Science for randomized controlled trials including patients with IBD receiving IL-targeting agents compared with patients receiving placebo or treatment that only differed from the intervention arm in the absence of an IL-targeting agent.

Choosing Therapy for Moderate to Severe Crohn's Disease.

The availability of approved therapies for Crohn's disease has significantly increased over the past decade. To choose the appropriate therapy for the patient, ideally head to head studies, and data on positioning could help the provider individualize the decision. Due to the paucity of head-to-head trial data, we turn to network meta-analysis and real-world studies to help guide our treatment choices.

Development of Shingles on Tofacitinib Despite Completion of Recombinant Varicella-Zoster Virus Vaccine Series.

Shingles, also known as herpes zoster, is caused by the reactivation of the varicella-zoster virus (VZV). The risk of developing shingles increases with age, as well as in patients with weakened immune systems. Tofacitinib is a reversible Janus kinase inhibitor that suppresses the immune system and is used to treat autoimmune diseases, such as ulcerative colitis.

The Role of Vitamin D in Patients with Inflammatory Bowel Disease Treated with Vedolizumab.

Background: Many clinical factors can contribute to the efficacy of medical therapy in Inflammatory Bowel Disease (IBD). We assessed their effects on the efficacy of vedolizumab therapy in a cohort of patients with IBD.

Methods: We conducted a retrospective study on patients between 18 and 80 years of age with ulcerative colitis (UC) or Crohn's disease (CD) who were seen in the IBD program at Houston Methodist in Houston, TX and treated with vedolizumab for at least 6 months from 2018 to 2022.

Real-world impact of infliximab precision-guided dosing on management of patients with IBD.

Objectives: Evaluate the clinical utility of a precision-guided dosing test for infliximab (IFX) and its impact on treatment decision-making for inflammatory bowel disease (IBD).

Study Design: Prospective, multisite, clinical experience program.

Methods: Health care providers were given access to PredictrPK IFX, a precision-guided dosing test, for their patients with IBD on maintenance IFX therapy.

Integrating Intestinal Ultrasound into an Inflammatory Bowel Disease Practice: How to Get Started.

Intestinal ultrasound (IUS) offers a safe, noninvasive, point-of-care tool for diagnosing and monitoring disease activity in patients with inflammatory bowel disease (IBD). IUS is used widely in Europe and Canada for IBD, but it remains underutilized in the United States. Growing interest in IUS in the United States has prompted many IBD centers to train their faculty in IUS.

Utility of Intestinal Ultrasound in Clinical Decision-Making for Inflammatory Bowel Disease.

Background: There is a clinical need to improve the monitoring of inflammatory bowel disease (IBD) activity. Despite being used regularly in European countries, intestinal ultrasound (IUS) has been implemented less in the United States for unclear reasons.

Aims: The aim of this study is to illustrate how IUS can be used as a clinical decision-making tool in an American IBD cohort.

Clinical Evaluation of Upadacitinib in the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis (UC): Patient Selection and Reported Outcomes.

This review addresses appropriate patient selection for upadacitinib, a Janus kinase inhibitor approved by the FDA and EMA for treatment of moderately to severely active ulcerative colitis (UC). Janus kinase molecules can contribute to the inflammatory pathway, so inhibiting certain of them may prove efficacious in treating UC and may reduce safety concerns. Upadacitinib is the newest Janus kinase inhibitor to be approved for UC, so it is timely and relevant to review patient selection and when to consider this medication.

The Role of Fecal Microbiota Transplantation in the Induction of Remission in Ulcerative Colitis.

Background: Considerable research supports an important role for the microbiome and/or microbiome-host immune system interactions in the pathogenesis of inflammatory bowel disease (IBD). Consequently, microbiota-modulating interventions, such as fecal microbiota transplantation (FMT), have attracted interest in the management of IBD, including ulcerative colitis (UC).

Summary: While the clinical response to FMT in UC has varied between different studies, results to date may offer guidance toward optimal use of FMT.

Ustekinumab Exposure in Pregnant Women From Inflammatory Bowel Disease Clinical Trials: Pregnancy Outcomes Through Up To 5 Years in Crohn's Disease and 2 Years in Ulcerative Colitis.

Background: While no adverse developmental outcomes were observed in preclinical animal studies, limited data exist regarding effects of ustekinumab on human pregnancies. Previously, no data have been reported for women treated with ustekinumab in inflammatory bowel disease (IBD) clinical trials and corresponding pregnancy outcomes. Here, we present pregnancy outcomes from IBD clinical trials, incorporating 5 years of treatment in Crohn's disease (CD) and 2 in ulcerative colitis (UC).

The Current State of Care for Black and Hispanic Inflammatory Bowel Disease Patients.

Research on the care of inflammatory bowel disease (IBD) patients has been primarily in populations of European ancestry. However, the incidence of IBD, which comprises Crohn's disease and ulcerative colitis, is increasing in different populations around the world. In this comprehensive review, we examine the epidemiology, clinical presentations, disease phenotypes, treatment outcomes, social determinants of health, and genetic and environmental factors in the pathogenesis of IBD in Black and Hispanic patients in the United States.

Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician.

Several biologic therapies have been approved for enteric diseases. We evaluate each biologic's role based on their mechanism of action in treating these conditions. This review examines data on efficacy and safety, as well as considerations for using these therapies in clinical practice in inflammatory bowel diseases, enteric infections-specifically colitis-and potentially in the increasingly prevalent disorder of eosinophilic esophagitis.