Proactive Fecal Calprotectin Home Monitoring in Ulcerative Colitis: Results of a Prospective Randomized Controlled...

Elevated fecal calprotectin (FC), a biomarker of intestinal inflammation, can be detected 3 months before symptomatic flare in patients with ulcerative colitis (UC). We hypothesized that proactive home-based FC monitoring would prevent symptomatic flares in patients with UC in remission.

This prospective, multicenter clinical trial randomized adults with a modified partial Mayo score ≤2 and no rectal bleeding to standard care or FC testing every 2 months for 18 months or until symptomatic flare. Confirmatory FC testing was performed within 2 weeks for FC ≥250 μg/g; change in therapy was at physician discretion. Primary end point was time to symptomatic flare. Secondary end points included health care use, medication use, and quality of life.

The trial enrolled 716 patients; 308 in the control arm and 303 in the intervention arm were analyzed. Mean age was 42 years, and 47% were men. Distribution of disease extent was similar in both arms, and 45% were on advanced therapy. Symptomatic flare occurred in 32% in both arms; median time to flare was not reached. There was no difference in risk for symptomatic flare overall (hazard ratio, 1.05; 95% confidence interval, 0.79-1.40), by disease extent, or advanced therapy use. Flare frequency was lower among the 88 who changed therapy after confirmatory elevated FC (49% vs 55%), but flare risk was not different. There were no differences in secondary end points.

Our results suggest that proactive home-based FC monitoring without protocolized escalation does not prevent symptomatic flares. Additional studies are needed to define the optimal use of FC monitoring and the benefit of early intervention.

gov number: NCT03549988.