Proactive Tight Monitoring of Patients with Inflammatory Bowel Disease in Biological Therapy: A Controlled Clinical Study (TIME IT).

Background/Objectives: The combined goal of achieving both clinical and endoscopic remission has highlighted the need for strategies that support a treat-to-target approach in inflammatory bowel disease (IBD). A proactive monitoring strategy involves scheduled assessments regardless of symptoms to detect subclinical disease activity and enable timely treatment adjustments, whereas a reactive approach initiates evaluation only in response to clinical deterioration or objective signs of active disease. This study investigated whether proactive monitoring improves the achievement of treatment goals compared with a reactive strategy. Methods: In this prospective cohort study carried out between September 2020 and July 2022, patients with IBD receiving biologic therapy were managed according to a predefined proactive monitoring schedule and prospectively followed for one year. A control group, matched for age, sex, diagnosis, and treatment, was enrolled from another tertiary IBD center using a reactive monitoring strategy; their clinical course over one year was reconstructed retrospectively from medical records. All patients underwent colonoscopy assessment at one year. The primary outcome was treatment failure, defined as inadequate mucosal healing or symptom control, the need for intestinal surgery, or discontinuation of biologic therapy due to insufficient efficacy. Results: A total of 162 patients were included (91 managed proactively and 71 managed reactively). In the intention-to-treat population, treatment failure occurred in 67 patients (74%, 95% confidence interval (CI) 63-84%) in the intervention group and 60 patients (85%, 95% CI 75% to 94%) in the control group (difference 11%, CI -3% to 25%, p = 0.13). In the per-protocol analysis, 44 of 69 patients (64%, CI 50% to 78%) in the intervention group experienced treatment failure compared with 43 of 53 patients (81%, CI 60% to 93%) in the control group (difference 17%, CI -1% to 36%, p = 0.06). Patients in the proactive monitoring group underwent significantly more disease-monitoring assessments than those managed reactively. Conclusions: Proactive monitoring numerically improved combined clinical and endoscopic outcomes compared with reactive management, but this did not reach statistical significance and resulted in substantially greater healthcare resource utilization.