Describing the Consequences of Delays in Biologic Therapy in IBD (DECODE-IBD)
Biography Overview Crohn’s disease and Ulcerative colitis are chronic, relapsing inflammatory disorders of the alimentary tract, characterized by diarrhea, hematochezia, and chronic abdominal pain. Treatment is dictated by disease severity, with moderate to severe disease often requiring immunosuppressive medications targeting Tumor Necrosis Factor-alpha(anti-TNFs), leukocyte trafficking, or cytokine signaling.
Delays in the diagnosis or treatment of inflammatory bowel disease (IBD) may worsen an individual’s clinical course. Diagnostic delays have been shown to significantly increase the probability of stricture or surgery in both children and adults. Delaying biologic initiation may also impact the course of IBD. In a pivotal clinical trial examining early combination infliximab and thiopurine therapy versus “stepping-up” to greater immunosuppression in CD, early combination therapy resulted in a 24.1% increase in steroid-free remission at 26 weeks. Another study appreciated a significant 0.8% increased risk of surgery for each month-long delay in anti-TNF initiation. Little is known how delays in the acute medication initiation process may affect outcomes, however.
Several factors may contribute to delays in the process of modern IBD therapy initiation. Patients must agree to start a medication, undergo laboratory screening, receive insurance approval, and schedule the infusion or self-injection training. The typical length of time required to complete this process has not been described. Each step of this process may lengthen time to starting a modern IBD medication. For example, our prior research demonstrated that delays induced by the interpretation of indeterminate serologic tests for latent tuberculosis in IBD patients prolong the time to first anti-TNF dose and increase the risk of subsequent hospitalization at 60 days after adjusting for multiple other disease, patient, and provider-level factors. Similarly, while effective in reducing costs for insurers, delays resulting from prior authorization processes may have deleterious clinical consequences. This has been appreciated in several other disease processes, but has not been assessed in IBD.
We therefore hypothesize that several physician-, healthcare system-, patient-, and insurance-related factors may influence the time required to initiate a biologic medication. We also hypothesize that these acute delays in medication initiation have clinical consequences. To address these knowledge gaps, we propose the following aims:
Specific Aim 1: To describe the time intervals involved in initiating modern IBD therapy in patients with inflammatory bowel disease and the physician-, healthcare system-, patient-, and insurance-related factors that are associated with increases in these intervals.
Specific Aim 2: To determine the impact of delays in initiating modern IBD therapy on key clinical outcomes including hospitalization, surgery, and cumulative steroid use.
Time
|