Research

The Center for Inflammatory Bowel Disease (IBD) at Beth Israel Deaconess Medical Center is a leading tertiary referral center dedicated to the diagnosis and treatment of Crohn’s disease and ulcerative colitis. Under the leadership of Dr. Adam Cheifetz, and in collaboration with partner IBD centers across the country and internationally, we are committed to advancing patient care through innovation and discovery.

Our team is internationally recognized for pioneering work in therapeutic drug monitoring of biologics, establishing BIDMC as a world leader in this field. Beyond TDM, the Center is well known for cutting-edge clinical and translational research in precision medicine and novel therapeutic targets for IBD. Our research portfolio spans large retrospective and prospective studies, randomized controlled trials, quality improvement projects, and both investigator-initiated and industry-sponsored studies; each designed to optimize our therapies and accelerate the development of new treatments for Crohn’s disease and ulcerative colitis.

 

Dr. Adam Cheifetz is Professor of Medicine at Harvard Medical School and Director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center (BIDMC). He is an internationally recognized leader in the care of patients with Crohn’s disease and ulcerative colitis, combining clinical expertise, research innovation, and education to improve outcomes for individuals living with inflammatory bowel disease (IBD).

Dr. Cheifetz has published more than 250 peer-reviewed articles and book chapters and is best known for pioneering the use of therapeutic drug monitoring (TDM) to optimize biologic therapy in IBD. His group was the first to demonstrate that proactive monitoring of infliximab concentrations and dosing to a therapeutic window improves outcomes compared with standard care. They also showed that proactive TDM is associated with greater treatment persistence, fewer IBD-related hospitalizations and surgeries, and reduced rates of anti-drug antibodies and infusion reactions. More recently, his team was the first to establish that proactive TDM of adalimumab leads to superior long-term outcomes. This body of work has directly shaped national and international guidelines, making TDM a standard of care for IBD and other immune-mediated inflammatory conditions.

Konstantinos Papamichail, MD, PhD is internationally recognized for his innovative research in the field of therapeutic drug monitoring (TDM) of biologic therapy in IBD. As a recipient of the very prestigious Fellowship Grant from the European Crohn's and Colitis Organization (ECCO), he performed pioneer studies to investigate the role of TDM of anti-tumor necrosis factor (anti-TNF) therapy during the induction phase in patients with IBD. One of the most important finding of his research was the identification of clinically relevant infliximab and adalimumab concentration thresholds during induction therapy associated with early mucosal healing in patients with ulcerative colitis allowing physicians to early optimize anti-TNF therapy towards better patient care. He is also well known for his novel research on the role of proactive TDM of anti-TNF-therapy in IBD showing that proactive TDM is associated with better therapeutic outcomes compared to empiric treatment optimization and/or reactive TDM. Dr. Papamichail was one of the leading members in a Consensus Meeting and the first author of a collaborative paper, published in Clinical Gastroenterology and Hepatology, of the Building Research in IBD Globally (BRIDGe) group on how to better apply TDM in clinical practice. Based on this publication the BRIDGe Biologic Therapy Optimizer was developed to help providers improve the efficacy and safety of biologic therapy and better treat IBD patients. He is also a founding member of the intErnational Consortium of Therapeutic dRUg Monitoring (spECTRUM). This is a consortium with global perspectives including TDM specialists from all over the world aiming to determine the utility of TDM in clinical practice towards tailored personalized treatment of patients. Dr. Papamichail is invited to lecture both nationally and internationally and has received numerous awards and distinctions. He is a member of the Clinical Committee of ECCO and the Research Committee of the American College Gastroenterology (ACG). Dr. Papamichail is the author of more than 155 publications with a Google Scholar h-index of 45.

The BIDMC IBD Center actively participates in industry-sponsored clinical trials investigating innovative pharmacologic therapies for Crohn’s disease and ulcerative colitis. These studies aim to expand treatment options and optimize therapeutic strategies for patients living with IBD.

Under the leadership of Dr. Laurie Grossberg, the BIDMC IBD Biorepository is enrolling patients for longitudinal collection of biological samples and clinical data. This growing repository provides a critical resource for translational and clinical research, facilitating discoveries that advance understanding of disease mechanisms and improve patient care in IBD.

Our center has led research studies and educational initiatives on the safety and management of IBD therapies across the lifespan, including fertility, pregnancy, lactation, and beyond. By generating real-world data and providing clinical expertise, we have helped ensure that women with IBD can achieve healthy pregnancies without compromising their own disease control.

Our center maintains an active roster of patient-oriented studies, with topics frequently generated by our patients. In partnership with our patient cohort, we have led studies on family planning, dietary habits, health counseling and maintenance, and medication use. We believe that the best way to improve IBD care is by understanding and studying the issues that matter most to our patients.

Dr. Flier's clinical focus is on Inflammatory Bowel Disease and she has a specific clinical and research interest in patients transitioning from pediatric to adult care. Current IBD-related studies include an assessment of clinical outcomes in IBD patients with iron deficiency without anemia, a survey of coping skills, transition readiness in young adults with IBD and an investigation into the presence and impact of health-related trauma in young adult patients with IBD. 

Dr. Flier's research within the quality and safety sphere covers a wide array of topics highlighting her broad oversight of quality and safety within the GI division. Examples of active projects include studies to understand predictors of and barriers to successful Helicobacter Pylori eradication identified on biopsy at our institution, a survey of screening practices for cannabis use and mental health comorbidities when counseling patients for endoscopic sedation and a study of the impact of cannabis use on patient experience and procedural outcomes in moderate sedation vs monitored anesthesia care. 

Dr. Maria Serena Longhi's research aims at defining how immune responses are regulated in chronic inflammatory statuses and in autoimmune disorders, including inflammatory bowel disease and autoimmune hepatitis. Her research program includes the following areas of interest:

Interactions between purinergic, hydrocarbon and oxygen mediated pathways in inflammatory bowel disease. Dr. Longhi's laboratory has found that effector Th17 cells obtained from the peripheral blood and lamina propria of Crohn's disease patients express low levels of CD39, an ectonucleotidase that is key to immune homeostasis by hydrolyzing pro-inflammatory nucleotides into immunosuppressive adenosine. Defective CD39 expression derives from impaired response of Th17 cells to ligands of aryl hydrocarbon receptor (AhR), a receptor for toxins/xenobiotics that also modulates adaptive immunity. Recent studies from her laboratory have shown that in Crohn's disease poor response to AhR ligands results from low oxygen levels, derived from protracted tissue inflammation. Her current research in this area aims at defining how alterations in the CD39, AhR and oxygen pathways can be therapeutically corrected.

Regulation of AhR signaling in autoimmune hepatitis. Dr. Longhi aims to identify key mechanisms that lead to functional impairment of regulatory T cells (Treg), a lymphocyte subset central to immunotolerance maintenance. Multiple mechanisms contribute to Treg impairment in patients with autoimmune hepatitis. As part of these investigations Dr. Longhi's laboratory is currently defining the alterations in AhR signaling pathways leading to Treg dysfunction in this autoimmune condition.

Post-transcriptional regulation of CD39 in inflammatory bowel disease. Dr. Longhi is defining the role of endogenous antisense RNAs, as modulators of CD39 expression and activity in both regulatory and effector cells in inflammatory bowel disease. Factors contributing to antisense RNA upregulation in Tregs and Th17 cells are also investigated.

Our center is engaged in multiple research protocols aimed at identifying biomarkers associated with disease activity, therapeutic response, and fibrosis in Crohn’s disease. These studies are integral to developing personalized treatment approaches and improving long-term outcomes for patients.
 
Dr. Efi Kokkotou specializes in developing tools and methodologies to study the molecular determinants of disease variability among patients with IBD that can also affect their responses to available treatments. The ultimate goal of her research is to help match the “right” treatment to the “right” person. For that purpose, her team is using the patient's own intestinal biopsy material to test various drugs in the lab and find which one might be more effective for the individual patient. Though still at an experimental stage, this approach holds great promise in the future for guiding personalized therapies in IBD and recently Dr. Kokkotou and BIDMC have been awarded a U.S. patent for this therapeutic response predictor assay-TheRPA. Given the still sub-optimal rates of therapeutic responses even with the newest medications for IBD, there is an unmet need to come up with new drugs that are more effective and with fewer side effects. Using the TheRPA technology and patient-derived samples, in partnership with the National Institutes of Health and the pharmaceutical industry, Dr Kokkotou's lab participates to the pre-clinical evaluation of several candidate drugs every year with emphasis on existing drugs that can be repurposed for the treatment of IBD in the foreseeable future.

Our research group is also investigating the application of artificial intelligence algorithms to endoscopic imaging. Current work focuses on using AI to detect active ulcerative colitis and explore its potential utility in clinical trial recruitment and real-time disease assessment.

Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Crohn's Disease: The OPTIMIZE Trial

 

This is a multi-center randomized controlled trial which is funded by the Leona M and Harry B. Helmsley Charitable Trust.

Therapeutic drug monitoring of biological therapy in patients with inflammatory bowel disease.

 

This project consists of retrospective and prospective studies as well as post-hoc analyses of randomized controlled trials aiming to investigate the role of therapeutic drug monitoring for optimizing biologic therapy in patients with inflammatory bowel disease

 

intErnational Consortium of Therapeutic dRug Monitoring (spECTRUM) spECTRUM image two jpg

This is a consortium with global perspectives including 53 scientists from 23 countries in 5 continents aiming to determine the utility of therapeutic drug monitoring of biologics in clinical practice towards tailored personalized medicine and better patient care. 

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