P0607Proactive disease monitoring versus reactive monitoring of patients with Inflammatory Bowel Disease in biological therapy: A controlled clinical study (TIME IT)

Abstract Background A composite treatment goal combining clinical and endoscopic remission has become a widely accepted therapeutic target in inflammatory bowel disease (IBD) (1). To achieve this target evidence-based monitoring strategies are needed. Proactive monitoring involves scheduled assessments to detect subclinical disease activity and enable timely therapeutic adjustments, whereas reactive monitoring relies on clinical worsening to trigger evaluation and therapy adjustments. This study aimed to determine whether proactive monitoring improved clinical and endoscopic outcomes compared with reactive monitoring in patients with IBD receiving biologic therapy. Methods This was a prospective cohort study including patients with IBD receiving biologic therapy from a tertiary IBD center and managed with proactive monitoring by following a predefined schedule (Table I) (intervention group). The control group enrolled from another tertiary IBD center, consisted of patients with IBD matched for age, sex, diagnosis, and biologic therapy. They were followed retrospectively and managed with reactive monitoring at the discretion of the treating physician. Both groups were followed for one year and underwent colonoscopy at the end of follow-up. The primary endpoint was treatment failure, defined as inadequate mucosal healing (SES-CD 2/Mayo 1) or inadequate symptom control (HBI 5 /SCCAI 2), systemic steroids, IBD-related surgery, or discontinuation of biologic therapy due to insufficient efficacy. Results In total 162 patients were included, 91 patients in the intervention group and 71 in the control group. Treatment failure in the intention-to-treat population occurred in 67 (74%) patients in the intervention group vs. 60 (85%) patients in the control group (p = 0.13). Per protocol, treatment failure occurred in 44 of 69 patients (64%) in the intervention group compared to 43 of 53 patients (81%) in the control group (p = 0.06). Use of diagnostic tests during proactive monitoring was significantly higher compared to reactive monitoring (blood samples median 9 IQR 7-10.5 vs. 7 6.5-9, p 0.001; therapeutic drug monitoring 3 2-4 vs. 0 0, p 0.001; medical consultations 5 3-8 vs. 4 3-5, p 0.001; disease activity indices 9 8-11 vs. 5 3-7, p 0.001; fecal calprotectin samples 3 2-4 vs. 2 1-3, p = 0.03). Change of biologic therapy was more common in the intervention group (n = 24 (26.4%) vs. n = 7 (9.8%), p = 0.005), while numerically fewer patients had IBD-related admissions compared to the control group (n = 11 (12%) vs. n = 13 (18.3%), p = 0.18). Conclusion There were no significant benefits of a proactive approach in achieving a clinical and endoscopic combined treatment goal, and the approach resulted in higher use of health care utilization. Reference: 1. Turner D, Ricciuto A, Lewis A, D’Amico F, Dhaliwal J, Griffiths AM, et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021;160(5):1570-83. Conflict of interest: Mrs. Risager Christensen, Katrine: speaker for Takeda and Janssens-Cilag Saadi Abbas Al-Obaidi, Osamah: No conflict of interest Buhl, Sine: No conflict of interest Fremberg Ilvemark, Johan: Research grants from Takeda, Janssen, Abbvie, and ParaTech Steenholdt, Casper: Lectures for Takeda, MSD and Janssen-Cilag research grant from Takeda. Brynskov, Jørn: participated in educational or advisory board activities at Abbvie, Takeda, Janssen, Bristol Meyers Squibb, Pfizer, and Gilead Ainsworth, Mark Andrew: Other: None