Publications

2026

Rabinowitz, L G, A Gade, T Deyhim, and J D Feuerstein. (2026) 2026. “Safety and Use of IBD Therapies During Pregnancy and Lactation.”. Expert Review of Gastroenterology & Hepatology 20 (2): 81-92. https://doi.org/10.1080/17474124.2026.2615447.

INTRODUCTION: Inflammatory bowel disease (IBD) commonly affects young women and frequently overlaps with peak reproductive years. Despite this overlap, there remains limited data on the safety and efficacy of IBD treatments during pregnancy and lactation, and many gastroenterology trainees report limited exposure to managing pregnant patients with IBD. Optimal management of IBD in pregnancy ideally starts before conception, with a goal of at least 3 months of steroid-free remission. The preconception period is critical for patient education and therapeutic optimization for patients with IBD. Optimized management during pregnancy and lactation is necessary to prevent adverse maternal and fetal outcomes.

AREAS COVERED: In this review, we discuss latest evidence on the safety and efficacy of available IBD therapies during conception, pregnancy, and lactation. Medications discussed include 5-aminosalicylates, biologic therapies, calcineurin inhibitors, Janus kinase inhibitors, corticosteroids, immunomodulators, and sphingosine 1-phosphate receptor modulators.

EXPERT OPINION: While most IBD therapies can be safely continued during pregnancy and lactation. Patient education during the preconception period is critical for maintenance of remission during pregnancy and postpartum. Evidence-based research and representation of pregnant patients with IBD in future studies are necessary to address existing knowledge gaps to optimize maternal and neonatal outcomes.

Amat, Maelys, Dora Huang, Dru Ricci, James Benneyan, Sarah Flier, Hariharan Shanmugam, Scot Sternberg, et al. (2026) 2026. “Evaluation of a Telephone Outreach Intervention on Colonoscopy Completion Rates for Patients With Rectal Bleeding.”. Journal for Healthcare Quality : Official Publication of the National Association for Healthcare Quality 48 (1). https://doi.org/10.1097/JHQ.0000000000000514.

BACKGROUND: Rectal bleeding is a common concern among primary care patients and a risk marker for colorectal cancer. Yet, primary care patients who present with rectal bleeding frequently do not complete timely colonoscopies. We sought to determine if a phone-based, scheduling intervention for patients presenting with rectal bleeding in primary care would improve the rate of scheduling and completion of ordered colonoscopies.

METHODS: We conducted a nonrandomized pre-post intervention study at an urban, academic, hospital-based primary care clinic. We included patients with a colonoscopy order for rectal bleeding who had not scheduled a colonoscopy within 2 weeks of the order date. We created a baseline cohort from August to October 2022 and an intervention cohort from November 2022 to June 2023. The pilot intervention involved up-to-3 outreach phone calls by a primary care-based phone service representative to study participants.

RESULTS: Compared to the baseline cohort, patients in the intervention cohort had a significantly higher rate of colonoscopy completion at 365 days ( p = .04). Higher rates in loop closure were seen across demographic cohorts.

DISCUSSION: Proactive, primary care-based, outreach phone calls increased rates of completion of colonoscopies ordered for rectal bleeding.

Gromova, Barbora, Viera Kupcova, Marie Serena Longhi, and Roman Gardlik. (2026) 2026. “Neutrophil-T Cell Cross Talk in Noninfectious Liver Diseases.”. American Journal of Physiology. Gastrointestinal and Liver Physiology 330 (1): G10-G28. https://doi.org/10.1152/ajpgi.00192.2025.

Sterile inflammation, resulting from hepatocyte death and subsequent release of damage-associated molecular patterns (DAMPs), significantly contributes to liver disease pathogenesis. Neutrophils, as primary responders to liver injury, undergo NETosis-an immune response generating neutrophil extracellular traps (NETs), further amplifying inflammatory damage. Extracellular DNA (ecDNA), a major constituent of NETs and released cell fragments, potentiates inflammation through pattern recognition receptor activation. Mitochondrial DNA, released during hepatocyte damage, especially provokes robust immune responses due to its bacterial DNA-like structure and unmethylated CpG motifs. Concurrently, purinergic signaling-particularly via ATP release and its conversion into adenosine by ectonucleotidases CD39 and CD73-critically modulates immune homeostasis and inflammatory responses. Dysregulated expression of CD39/CD73, driven by altered aryl hydrocarbon receptor (AhR) signaling, exacerbates inflammatory states through disturbed regulatory T (Treg) and T helper (Th) 17 cell balance. Recent insights highlight that neutrophils and NETs not only drive innate inflammatory responses but significantly influence adaptive immunity by modulating T cell differentiation. NET components, such as cathelicidin and histones, actively promote Th17 differentiation while simultaneously impairing Treg functions, thereby sustaining inflammatory conditions. In addition, T cells reciprocally influence neutrophil activation and recruitment, predominantly through interleukin-17A (IL-17A) production. Detailed mechanisms underlying neutrophil-T cell cross talk in autoimmune hepatitis, acute liver failure, ischemia/reperfusion injury, alcoholic liver disease, and metabolic dysfunction-associated steatotic liver disease underscore potential therapeutic targets. Future strategies targeting NET formation, ecDNA clearance via DNase therapy, purinergic receptor modulation, and restoring AhR signaling hold promise for effectively attenuating sterile inflammation and immune dysregulation in liver diseases.

2025

Gade, Ajay, Alessandra Saraga, Tina Deyhim, Grace Geeganage, Samantha Zullow, Loren G Rabinowitz, Laurie B Grossberg, Adam S Cheifetz, and Konstantinos Papamichael. (2025) 2025. “Proactive Compared to Reactive Therapeutic Drug Monitoring Is Associated With Less Treatment Failure in Patients With Inflammatory Bowel Disease Treated With Adalimumab.”. Digestive Diseases and Sciences. https://doi.org/10.1007/s10620-025-09597-5.

PURPOSE: There are limited data regarding the role of proactive therapeutic drug monitoring (TDM) in patients with inflammatory bowel disease (IBD) treated with adalimumab (ADM). The aim of the study was to investigate the long-term outcome of patients with IBD undergoing proactive versus reactive TDM in terms of treatment failure.

METHODS: This single-center, retrospective, cohort study included consecutive patients with IBD who received maintenance ADM therapy and underwent TDM from January 2018 to March 2023. The proactive TDM group consisted of patients who had at least one proactive TDM during the follow-up time, while the reactive TDM group consisted of patients who underwent only reactive TDM. Patients were followed from first TDM until treatment failure or the end of the follow-up period (May 2024). Treatment failure was defined as either drug discontinuation due to loss of response/serious adverse event or an IBD-related surgery.

RESULTS: The study population consisted of 277 patients with IBD (n = 206, 74% with Crohn's disease), who underwent either proactive (n = 217) or reactive (n = 60) TDM. Patients were followed for a median of 39.5 (interquartile range 25.1-55.2) months. Multiple Cox regression analysis identified proactive TDM to be associated with less treatment failure [hazard ratio (HR 0.26, 95% confidence interval (CI) 0.16 to 0.42, p < 0.001], while stricturing CD (HR 2.1, 95% CI 1.3 to 3.5, p = 0.003) and antibodies to ADM at first TDM (HR 2.5, 95% CI 1.4 to 4.4, p = 0.002) were associated with treatment failure.

CONCLUSIONS: In this large cohort study, proactive when compared to reactive TDM was associated with less treatment failure in patients with IBD receiving ADM maintenance therapy.

Povlsen, Sebastian, Kamal Patel, Xavier Roblin, Konstantinos Papamichael, and Sailish Honap. (2025) 2025. “Therapeutic Drug Monitoring in Special Circumstances in Inflammatory Bowel Disease.”. Journal of Clinical Medicine 14 (22). https://doi.org/10.3390/jcm14227956.

Inflammatory bowel disease, encompassing ulcerative colitis and Crohn's disease, is characterised by chronic immune-mediated inflammation and variable treatment response. Loss of drug efficacy due to underexposure, pharmacokinetic variability, and immunogenicity remains a key challenge. Therapeutic drug monitoring, using drug levels and anti-drug antibody measurements, is an important strategy for optimising the treatment of inflammatory bowel disease. It helps ensure adequate dosing and can distinguish between pharmacokinetic and mechanistic drug failure. Most evidence pertains to infliximab and adalimumab. Multiple factors influence drug pharmacokinetics, affecting both target drug levels and the doses required to achieve them. These include inflammatory burden, bodyweight, age, disease phenotype, and route of administration, all of which are important considerations for individualising treatment in inflammatory bowel disease. This narrative review explores how special clinical situations-acute severe ulcerative colitis, perianal fistulising Crohn's disease, hypoalbuminaemia, extremes of body composition, pregnancy, paediatrics, and advanced age-alter drug pharmacokinetics and influence the utility and interpretation of therapeutic drug monitoring in inflammatory bowel disease.

Brenner, Todd A, Chris Labaki, Joseph D Feuerstein, and Tyler M Berzin. (2025) 2025. “Prospective Validation of the First FDA-Approved Computer-Aided Quality (CAQ) Assessment Tool for Colonoscopy: An Initial Clinical Experience.”. The American Journal of Gastroenterology. https://doi.org/10.14309/ajg.0000000000003855.

OBJECTIVES: We report a prospective pilot of GI Genius ColonPro 4.0 (Medtronic, Minneapolis, MN), the first FDA-approved computer-aided quality (CAQ) platform for colonoscopy.

METHODS: ColonPro measurements of withdrawal time, cecal intubation, and Boston Bowel Preparation Score (BBPS) were compared with independent video review in 110 outpatient colonoscopies.

RESULTS: Agreement between the CAQ and physicians was poor for BBPS (ICC=0.40, p<0.001) but strong for withdrawal time (ICC=0.89, p<0.001) and cecal intubation (κ=0.79, p<0.001).

CONCLUSIONS: CAQ reliably measures withdrawal time and cecal intubation, but AI-based BBPS scoring requires further validation before integration into current paradigms of colonoscopy quality.

Gade, Ajay, Alessandra Saraga, Tina Deyhim, Grace Geeganage, Adam S Cheifetz, and Konstantinos Papamichael. (2025) 2025. “Treatment Optimization of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease.”. Expert Review of Gastroenterology & Hepatology. https://doi.org/10.1080/17474124.2025.2591151.

INTRODUCTION: Subcutaneous infliximab (SC-IFX) is an efficacious medication for inflammatory bowel disease (IBD). However, there is limited information about treatment optimization following loss of response (LOR), the role of therapeutic drug monitoring (TDM) and combination therapy with an immunomodulator (IMM) and efficacy of SC-IFX in perianal fistulizing Crohn's disease (CD).

AREAS COVERED: This narrative review will provide an overview of the efficacy of SC-IFX in IBD including perianal fistulising CD, the effectiveness of dose escalation after LOR and the role of TDM and IMM use. A literature search was performed using PubMed and reviewed references from applicable manuscripts and abstracts from major gastrointestinal medical congresses between January 2021 and 20 May 2025.

EXPERT OPINION: Current data suggest that SC-IFX is effective in the treatment of IBD. Moreover, cumulative data suggest that dose escalation is effective in recapturing response in patients with LOR, and that higher drug concentrations are associated with better outcomes. However, there are still major gaps in understanding the role of drug clearance, immunogenicity, and the role of TDM for optimizing SC-IFX. Moreover, the impact of body mass index and concomitant IMM therapy on clinical outcomes as well as the efficiency of SC-IFX in more complicated IBD phenotypes remains to be elucidated.

Lee, Jessica D, Konstantinos Papamichael, Lauren T Grinspan, Adam S Cheifetz, Melissa Spiel, Tatyana Kushner, and Loren G Rabinowitz. (2025) 2025. “Maternal and Perinatal Outcomes in Pregnant Women With Comorbid Inflammatory Bowel Disease and Chronic Liver Disease.”. Alimentary Pharmacology & Therapeutics. https://doi.org/10.1111/apt.70425.

BACKGROUND: Inflammatory bowel disease (IBD) and chronic liver disease (CLD) are each associated with adverse pregnancy outcomes, but the impact of coexisting IBD and CLD on pregnancy remains understudied.

AIMS: To assess CLD prevalence among pregnant women with and without IBD and evaluate maternal and perinatal outcomes.

METHODS: We conducted a retrospective cohort study of delivery hospitalisations among women ≥ 18 years using the 2016-2022 United States National Inpatient Sample. Deliveries were categorised as IBD + CLD, IBD, CLD or neither using ICD-10 codes. Weighted multivariable regression adjusted for demographics, comorbidities and cirrhosis.

RESULTS: Among 21,304,600 deliveries, 178,025 had CLD, 47,555 had IBD and 680 had IBD + CLD. Chronic viral hepatitis was the most common CLD, while autoimmune liver disease accounted for half of cirrhosis in IBD + CLD. Compared to IBD or CLD, IBD + CLD had higher odds of hyperemesis gravidarum (2.64 vs. 3.68), preterm birth (2.50 vs. 1.69), hypertensive disorders of pregnancy (HDP) (1.96 vs. 1.60), caesarean delivery (1.92 vs. 1.61), perinatal mood disorder (1.75 vs. 1.45) and premature rupture of membranes (1.35 vs. 1.39). IBD + CLD had greater odds of fetal death (1.97) versus CLD and of severe maternal morbidity (1.76) and postpartum haemorrhage (1.56) versus IBD. All p ≤ 0.05.

CONCLUSIONS: Coexisting IBD and CLD confer compounded maternal and perinatal risks beyond either condition alone. Multidisciplinary care and risk-based screening for underlying CLD in pregnant women are warranted.