Can We Use Therapeutic Monitoring of Drug Levels to Improve Long-Term Control of Patients Treated with Infliximab (Remicade) in IBD?

Principal Investigator: Emanuelle Araujo Lima Bellaguarda, MD The drug infliximab (Remicade) offers relief to millions of people with Crohn’s disease and ulcerative colitis. Yet, which dose is the best dose for effectively treating disease? The same dose does not work for all to prevent flare ups and improve quality of life. And how best to calibrate the dosage before the drug loses it efficacy and patients begin to experience the debilitating symptoms of their inflammatory bowel disease? Checking Remicade levels and adjusting the dosage after patients become unresponsive to the drug is already too late. Timing between infusions also becomes critical for modifying the dosage. Checking at the end of a dosage cycle doesn’t allow adequate time to adjust for the next infusion dose since it takes one week to turn around test results. Better personalizing the use of infliximab, Emanuelle Araujo Lima Bellaguarda, MD, a gastroenterology faculty member at Northwestern Medicine and her research team have designed a study to monitor and adjust dosing of the medication. In particular, they are interested in two key times during the therapeutic infusion timeline. The investigators hypothesize that adjusting infliximab at trough levels (the amount of drug present in the body at its lowest therapeutic concentration before the next dose) at weeks 12 and 28 may improve rates of sustained remission. This proactive screening approach has the potential to fully optimize the therapeutic effectiveness of infliximab for each and every patient. A study of this nature will require dedicated logistical coordination. Funding from the Digestive Health Foundation will support a study coordinator to manage patient enrollment, monitoring and outcomes during the...

Does Use of Methotrexate Impact Male Fertility in IBD Patients

Principal Investigator: Anne Grosen, MD Immunosuppressive drugs have made living with inflammatory bowel disease (IBD) easier. But these powerful medications have their drawbacks, especially when it comes to potentially affecting future fertility. Complicating matters, IBD often strikes people during their key reproductive years. Patients’ fertility fears may dissuade them from taking effective medication that could help them to better manage their disease. Methotrexate (MTX) is a commonly prescribed drug treatment for IBD. Linked to birth defects, though, it is not recommended for pregnant women. How the drug affects a man’s ability to start a family remains a mystery. Funded by a Digestive Health Foundation grant, Northwestern Medicine researchers led by visiting scholar Anne Grosen, MD, from Aarhus University Hospital in Denmark, plan to shed light on the effects of this potent drug by examining several markers of male fertility, including sperm quality and reproductive hormones.   Dr. Grosen’s research team, which includes GI and fertility and reproductive medicine specialists, will focus on adult males (ages 18 to 45) who have been diagnosed with Crohn’s disease or ulcerative colitis. Seen by the IBD team at Northwestern Medicine, these individuals are either planning to start MTX treatment or are currently taking the drug for their disease. A healthy control group will participate in a separate study in Denmark and be used for comparative purposes. By analyzing MTX metabolites and other biomarkers in blood and semen samples, the investigators hope to determine if MTX makes a clinically relevant impact on male fertility. Study findings of this trans-Atlantic collaboration have the potential to improve future patient care by allaying concerns about drug safety...

How Do We Improve Transitioning of Pediatric IBD Patients into Adult Practice

Principal investigator: Itishree Trivedi, MD Graduating from high school. Going away to college. Getting that first job. For many, these milestones mark the transition from childhood to adulthood, with parents and their children diligently preparing for them as they arise. Yet a young adult patient’s move from beloved pediatrician or family doctor to an unfamiliar adult care specialist is often abrupt. Learning to be in charge of your own health can be challenging, especially for those with chronic illnesses. Inflammatory bowel disease (IBD), often identified as ulcerative colitis or Crohn’s disease, affects 1.4 million Americans. About 30 percent of IBD patients are diagnosed with the disease before age 18. The journey from adolescent to adult can be bumpy for anyone, but IBD comes with its own set of hurdles. Typically inhibiting physical growth and often causing social and developmental stresses, the disease can lead to missed doctors’ appointments, increased use of emergency rooms, and higher healthcare costs. “Transition programs” to prepare youth for adult care have been used for patients with conditions such as Type 1 diabetes mellitus and organ transplantation. Requiring “buy-in” from healthcare practitioners to be successful, these programs help young adults bridge the transition gap. They’ve been shown to prevent the worsening of disease and reduce hospitalizations. Supported by a grant from the Digestive Health Foundation, a young clinical investigator in Northwestern Medicine’s Division of Gastroenterology and Hepatology now intends to do the same for young adults with IBD. Adapting the GotTransition toolbox (developed by the Center for Health Care Transition Improvement), Itishree Trivedi, MD, plans to develop the first such program specifically geared toward improving...