DOP004 Proactive fecal calprotectin testing in ulcerative colitis: Initial results of the PROMOTE UC study

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Abstract Background Fecal calprotectin (FC) is a biomarker of mucosal inflammation widely used in the management of inflammatory bowel disease (IBD). Given the convenience of home-based FC testing, we hypothesized that intensive, proactive FC monitoring would prevent symptomatic ulcerative colitis (UC) flares by detecting elevated FC levels prior to symptom onset and allowing clinicians to optimize therapy. Methods This prospective, multicenter, randomized, observational clinical trial evaluated intensive home-based, FC testing (IBDoc, Bühlmann Laboratories) versus usual care in adults with UC in clinical remission, defined as a modified partial Mayo score (mpMayo) ≤2 with no rectal bleeding. Patients in the intervention arm used the home testing kit every 2 months for 18 months or until symptomatic flare. The decision to modify therapy based on an elevated FC result was left to the discretion of the attending physician. Patients in the control group were followed according to usual care for 18 months or until symptomatic flare. Clinical data were collected at baseline and every 6 months. The primary endpoint was the time to symptomatic flare, defined as an increase in mpMayo ≥2 points from baseline or a rectal bleeding score ≥1. Results A total of 584 patients were followed at 14 sites in Canada and Australia until symptomatic flare or end of study. Demographics were similar between the control (n=293) and intervention arms (n=291), including mean age (41.9 vs 41.9 years), sex (46.8% vs 49.1% male), disease duration (1.61 vs 1.44 years), and mean mpMayo (0.39 vs 0.40) (Table). At study end, the flare rate of 30.9% in the intervention arm with proactive monitoring was slightly lower than the flare rate of 32.8% in the control arm (median follow-up 549 and 562 days, respectively). Overall, HR for flare in the intervention vs control arm was 1.01 (95% CI: 0.76, 1.34; p=0.96) (Figure). Risk for flare was also similar when analyzed by disease extent (proctitis: 1.13 [0.60, 2.14, p=0.71]; left-sided disease: 0.99 [0.61, 1.58, p=0.95]; pancolitis: 0.96 [0.60, 1.53, p=0.86]) or biologic use (biologics: 1.29 [0.86, 1.95, p=0.22], non-biologics: 0.78 [0.52, 1.18, p=0.24]) at baseline. Conclusion In this large, prospective clinical trial, approximately one-third of patients with UC in clinical remission developed a symptomatic flare within 18 months. Longitudinal proactive FC monitoring was not associated with a reduction in clinical flares. Further study is needed to determine the utility of home-based FC testing in guiding the management of UC.