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.