Inflammatory bowel disease (IBD) is an umbrella term used to describe disorders that involve chronic inflammation of the digestive tract. The two main types of IBD are Crohn’s disease (CD) and ulcerative colitis (UC). While there is currently no cure for IBD, new treatments called biologics have been available for the treatment of IBD, helping patients reduce their symptoms, achieve and maintain remission, and prevent complications.
What are biologics?
Biologics are specialized antibodies that work by interrupting the immune system signals and reducing the body’s unnecessary inflammatory response. According to the Crohn’s & Colitis Foundation, biologic therapies offer a distinct advantage in IBD treatment because their mechanisms of action are more precisely targeted to the factors responsible for IBD.
Infliximab is one of the most frequently prescribed and effective medications against inflammatory diseases like Crohn’s disease and colitis. Infliximab works by blocking the actions of a certain natural substance in the body, known as TNF-alpha. This helps to prevent inflammation and relieve symptoms. However, despite the successful use of biologics as therapies for IBD, these diseases remain difficult to manage.
Drug response
Many patients do not respond to the induction therapy (primary non-response) or lose response during the treatment (secondary loss of response). Roughly 20-30% of patients do not respond to the initial treatment, and 10-20% of patients lose response each year of treatment.
Patients are losing response due to the fact that the infliximab label doses to a “typical patient,” which doesn’t take into account variability in patient clearance and half-life. This means that the maintenance dosing is either not enough drug or the dose interval is too long for patients to achieve sufficient drug exposure to minimize their loss of response.
Development of anti-drug antibodies
The main challenge of anti-tumor necrosis factor use in IBD is immunogenicity, or the immune-mediated formation of drug antibodies. Research has shown that a proportion of IBD patients lose response to biologics, partly due to the formation of anti-drug antibodies.
Anti-drug antibodies may cause adverse events that may be as benign as a mild itchy rash or as serious as anaphylaxis. Many factors that can lead to an increased risk of immunogenicity include:
- The design of the biologic (e,g, humanized versus fully human)
- Patient characteristics
- Dosage
- Route of administration of the biologic
Optimize Dosing Strategies With iDose
Choosing the correct dose for the right patient can be challenging for many clinicians. Clinicians utilize the standard dosing regimens established from randomized controlled trials and described in the product label when prescribing biologics to patients. However, these dosing regimens are based on the average patient, which is difficult to identify.
Optimized dosing strategies for individual patients are needed to achieve sufficient drug exposure during biologic therapy. By focusing on important, modifiable factors for regulating drug levels, iDose can improve the efficacy of inflammatory disease treatments in clinical settings.
iDose, our cloud-based software, uses Bayesian models, routine lab results, and demographic information to allow physicians to individualize dosing to a specific target trough level. Interested in how iDose can improve your patient outcomes? Schedule a Demo today!
