While there are treatments and surgical interventions available that can treat the symptoms of inflammatory bowel diseases (IBD) like Crohn’s disease (CD) and ulcerative colitis (UC), there is no cure for the chronic inflammatory condition that causes periods of intense flares of symptoms and periods of remission. With research, advancements have been made in the understanding and management of IBD, but the exact cause remains unknown, although research indicates that it is a combination of genetic, environmental, and immunological (related to the immune system) factors.1
Areas of current research in IBD include: 1-3
- Uncovering genetic mutations that are associated with CD and UC, which may provide targets for potential treatments
- Understanding the role of the gut microbiome (the population of bacteria that are present in the digestive system) in IBD
- New ways to diagnose IBD
- New treatment approaches, particularly in biologic therapy and immunotherapy
- Strategies for healing the mucosal layer of the intestines, which becomes damaged from the chronic inflammation of IBD
- Uncovering environmental factors that contribute to the development of IBD
Therapeutic drug monitoring
One of the newer classes of medications for people with IBD is biologics, like anti-tumor necrosis factor (anti-TNF) agents. These medications block a specific chemical, or cytokine, that is involved in the inflammatory process. Anti-TNF agents are effective for many people with IBD, but they do not work for about one-third of patients. Another one-third initially get better after starting an anti-TNF medication, but their disease eventually stops responding to the medication. 4
It’s not clear why the anti-TNF agents work better for some people than others. Some people need more of the drug than others to get the same benefits. However, most of the time, people get a standard dose. This means that some people are paying for more medication than they need or risking more adverse effects. On the other hand, some people may need more than the standard dose to get better. 5
One treatment approach is to check how much of the drug is in the body and adjust the dose. This approach is called “therapeutic drug monitoring.” So far, research shows that therapeutic drug monitoring saves money and patients do just as well. 6,7 There is also some evidence that therapeutic drug monitoring can reduce the number of people who stop responding to the medication. 5
More research in this area is needed. Some of the questions that need to be studied are: 5
- What is the best way to measure a person’s response to a particular medication
- What is the goal – improvement in symptoms or remission?
- What is the best time to monitor and adjust the dose: during treatment for active disease or when the drug is being used to maintain remission?
- What other medications can be used with anti-TNF agents to treat IBD?
Medications in development
New medications to treat IBD are being studied in large clinical trials. Clinical trials are done in steps, called “phases.”8
- Phase I: These trials include a small group of people. The goal is to find the safe dose range and study the side effects and safety of a medication.
- Phase II: These trials are done in a larger group of people. The goal is to see if the medication works and is safe.
- Phase III: These trials are done with a large group of people. The goal is to confirm that the drug works and to see how frequently side effects occur. These trials are usually the last step before the Food and Drug Administration (FDA) decides whether to approve the medication.
Clinical trials require large numbers of volunteers or participants to test the effectiveness and safety of new medications. By participating in a clinical trial, participants have access to the latest treatment advances. There are several questions participants consider before enrolling in a clinical trial, including how the trial will integrate with current therapies or healthcare providers. Each trial also has strict criteria on the type of patient they are looking for, and the criteria may include patients of a certain age or who have had (or not had) certain previous treatments.