Publications

2025

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.

Rabinowitz, Loren G, Ajay Gade, Tina Deyhim, Alessandra Saraga, and Joseph D Feuerstein. (2025) 2025. “Clinical Management of Inflammatory Bowel Disease from Preconception to Postpartum.”. Expert Review of Gastroenterology & Hepatology. https://doi.org/10.1080/17474124.2025.2577985.

INTRODUCTION: Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, often affects individuals during their peak reproductive years. Female patients with IBD face unique challenges across the reproductive years, from fertility and conception to delivery and lactation. Despite increasing awareness, knowledge gaps remain regarding optimal management during pregnancy and postpartum. This review outlines these challenges and provides a practical, evidence-based approach across reproductive stages.

AREAS COVERED: This review summarizes care for IBD in reproductive years, including preconception counseling, pregnancy management, delivery planning, surgical and perianal disease considerations, postpartum care, breastfeeding, and infant vaccination after biologic exposure.

EXPERT OPINION: Managing IBD from preconception through the postpartum period requires early planning, multidisciplinary coordination, and patient-centered care. Disease remission is the strongest predictor of maternal and fetal outcomes. Most IBD therapies, including biologics, are safe in pregnancy and lactation and should continue, except small molecules, which remain contraindicated due to teratogenic risk or limited safety data. Rotavirus and other vaccinations can generally be administered on schedule in infants exposed to biologics in utero. A proactive, treat-to-target strategy throughout pregnancy, combined with close postpartum monitoring, can prevent disease flares and support optimal outcomes for both mother and child.

Seika, Philippa, Jocelyn Chang, Su Min Hong, Sarah Ballou, Vikram Rangan, Chethan Ramprasad, Johanna Iturrino, et al. (2025) 2025. “Glucagon-Like Peptide-1 Receptor Agonists Are Associated With a Lower Risk of Peptic Ulcer Disease: A Nationwide Cohort Study.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association. https://doi.org/10.1016/j.cgh.2025.08.015.

BACKGROUND & AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are prescribed for type 2 diabetes mellitus (T2DM) to improve glycemic control and lower cardiovascular risk. Although the impact of GLP-1RAs on gastrointestinal motility has been characterized, their association with mucosal damage, such as in peptic ulcer disease (PUD), has received little attention.

METHODS: We conducted a nationwide retrospective study of adults with T2DM using the "All of Us" National Institutes of Health database, including a sub-group analysis of adults who were newly initiated on GLP-1RAs or insulin as second-line therapy. Our primary outcome was the odds of PUD diagnosis after time-dependent use of GLP-1RAs, adjusting for use of insulin, nonsteroidal anti-inflammatory drugs, steroids, and proton pump inhibitors and other confounders. In a subgroup analysis, we used a weighted, time-varying Cox proportional hazards model, while accounting for the competing risks of death and gastrectomy.

RESULTS: A total of 66,102 participants with T2DM were identified and included in our primary analysis. After adjusting for possible confounders, GLP-1RAs were associated with significantly lower odds of PUD diagnosis (adjusted odds ratio 0.56; 95% confidence interval, 0.45-0.71; P < .001). Our subgroup included a total of 3313 patients (1270 new GLP-1RA users; 2043 new insulin users). In this analysis, switching to a GLP-1RA as second-line therapy was associated with a significantly lower hazard of PUD compared with switching to insulin (adjusted hazard ratio [HR], 0.44; 95% confidence interval, 0.30-0.63; P < .001). The model confirmed that active use of nonsteroidal anti-inflammatory drugs (HR, 2.39) and steroids (HR, 1.84) were also associated with increased likelihood of PUD.

CONCLUSIONS: In this nationwide cohort study of patients with T2DM, GLP-1RA use was associated with 44% lower odds of PUD. In our propensity score-matched subgroup, switching to GLP-1RA as second-line therapy was associated with a 56% lower hazard of PUD vs insulin. These findings indicate an association between GLP-1RA use and reduced risk of PUD.

Geeganage, Grace, Ajay Gade, Alessandra Saraga, Tina Deyhim, Samantha Zullow, Loren G Rabinowitz, Adam S Cheifetz, Laurie B Grossberg, and Konstantinos Papamichael. (2025) 2025. “Long-Term Outcomes of Patients With Crohn’s Disease Treated With Risankizumab.”. Inflammatory Bowel Diseases. https://doi.org/10.1093/ibd/izaf162.

BACKGROUND: Cumulative data suggest that risankizumab is an effective and safe treatment for patients with Crohn's disease (CD). However, most of the data derive from randomized controlled trials or small retrospective studies with short- or mid-term follow-up. This study aimed to assess the long-term effectiveness and safety of risankizumab in a real-world cohort of patients with CD.

METHODS: This single-center, retrospective, cohort study included consecutive patients with CD treated with risankizumab from October 2022 to August 2024. A time-to-event analysis was performed for treatment failure, treatment escalation, and CD-related health care utilization. Treatment failure was defined as the need for drug discontinuation due to primary nonresponse, loss of response, or a serious adverse event or the need for IBD (inflammatory bowel disease)-related surgery. Treatment escalation was defined as the need for shortening the dose interval or intravenous reinduction due to breakthrough CD-related symptoms and/or elevated biomarkers, such as C-reactive protein and fecal calprotectin. Health care utilization was defined as CD-related emergency department visit or hospitalization. Patients were followed from start of risankizumab until drug discontinuation or the end of follow-up (October 2024).

RESULTS: The study population consisted of 106 patients with CD (74% receiving prior biological therapies). Patients were followed for a median of 12 [interquartile range (IQR), 6.8-18.8] months; 14 (13%) patients had treatment failure; 24 (23%) had treatment escalation; and 17 (16%) had CD-related health care utilization. Multivariable Cox proportional hazards regression analysis identified penetrating CD as associated with treatment failure [hazard ratio (HR), 5.2; 95% confidence interval (CI), 1.6-17.2; P = .007], while perianal fistulizing CD (HR, 3.3; 95% CI, 1.2-9.4; P = .023) and prior exposure to more than 2 biologics (HR, 5.8; 95% CI, 1.3-26.3; P = .022) were associated with treatment escalation.

CONCLUSION: In this real-world cohort with long-term follow-up, risankizumab was generally effective in patients with CD. Penetrating CD was associated with treatment failure, while perianal fistulizing CD and prior exposure to more than 2 biologics were associated with treatment escalation.

Goldowsky, Alexander, Andrew Eidelberg, Grace Geeganage, Ajay Gade, Oriana Pando, Alessandra Saraga, Tina Deyhim, et al. (2025) 2025. “Sexual Health and STI Counseling Is Critical But Often Overlooked in IBD.”. Digestive Diseases and Sciences. https://doi.org/10.1007/s10620-025-09396-y.

BACKGROUND: Sexual health counseling (SHC) is a critical aspect of inflammatory bowel disease (IBD) care. Less is known about sexual health counseling in patients who identify as members of a sexual or gender minority (SGM) group.

AIMS: This study aims to characterize patient-reported sexual health counseling in SGM vs. non-SGM patients with IBD.

METHODS: We conducted an anonymous, cross-sectional survey of patients over 18 years old with IBD, currently receiving care at a large, tertiary care IBD center. Data collection included demographics, IBD history, and patient recall of SHC. Patients who self-identified as SGM were compared to non-SGM patients, with subgroup analyses by sex assigned at birth. Means were compared using t tests and percentages compared using chi-square analysis.

RESULTS: A total of 162 patients (41 SGM and 121 non-SGM) completed the survey. Both groups reported IBD impacted their sexual practices (ranging from 44% non-SGM men to 64% SGM women). SGM patients were more likely to report that their gastroenterologist asked about sexual health compared to non-SGM patients (p < .005). Importantly, 31% of respondents reported seeking SHC from their gastroenterologist (GI), placing GIs among the top sources of information regarding sexual health in this cohort.

CONCLUSION: Most study participants reported that IBD has impacted their sexual practices. SHC rates were low in all study groups despite GI providers being a primary source of information. Clearer recommendations on aspects of SHC could improve quality of care for both SGM and non-SGM patients with IBD.