Feasibility and Preliminary Efficacy of combined home-based fecal calprotectin self-testing and therapeutic drug monitoring-guided intervention in Patients with moderate-to-severe inflammatory bowel disease.

BACKGROUND: Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, significantly impact patients' lives. Effective management often involves invasive and costly monitoring.

OBJECTIVE: To evaluate the feasibility of integrating home-based fecal calprotectin testing with therapeutic drug monitoring (TDM) in managing moderate-to-severe IBD.

METHODS: A prospective, single-arm pilot study involved patients performing weekly home-based fecal calprotectin tests and attending regular clinic visits for TDM. Data on adherence, clinical disease activity, fecal calprotectin levels, therapeutic adjustments, and healthcare utilization were collected and analyzed.

RESULTS: High adherence to home-based fecal calprotectin testing (88%) and strong concordance with laboratory-based fecal calprotectin measures were observed. Clinical disease activity scores significantly decreased from a baseline of 7.2-2.7 by week 24. The proportion of patients achieving clinical remission increased from 0% at baseline to 50% at week 24. TDM facilitated 28 therapeutic adjustments, including 20 dose escalations, five de-escalations, and three therapy switches.

CONCLUSION: Integrating home-based fecal calprotectin testing with TDM is feasible for personalized management of IBD. The observed clinical trends warrant confirmation in controlled trials.