Objective disease activity assessment and therapeutic drug monitoring prior to biologic therapy changes in routine inflammatory bowel disease clinical practice: TARGET‑IBD.

Challenge

IBD treatment guidelines recommend objective disease activity assessment and therapeutic drug monitoring (TDM) prior to biologic dose changes or discontinuation, yet the degree to which this is practiced in real-world US IBD care had not been measured, raising concerns about suboptimal treatment decision-making.

Solution

The TARGET-IBD registry was used to characterize the proportion of IBD patients undergoing objective disease activity assessment or TDM in the 12 weeks prior to biologic dose changes or discontinuation for lack of efficacy, with subgroup analyses by disease type and treatment class.

Impact

Establishing that nearly one-third of patients undergo biologic therapy changes without objective assessment or TDM creates the evidence base for quality improvement initiatives in IBD care, supporting prescriber education programs and informing regulatory guidance on monitoring requirements in IBD biologic drug development.