Home Fecal Calprotectin Monitoring in Ulcerative Colitis Falls Short

Key Takeaways

• Home fecal calprotectin monitoring every 2 months was not associated with fewer symptomatic flares than standard care.
• No between-group differences were reported by disease extent or advanced therapy use, and secondary end points were also similar.
• The authors concluded that home monitoring without a protocolized escalation pathway did not prevent symptomatic flares, and that further study is needed.

In a prospective multicenter randomized trial, adults with ulcerative colitis in remission had symptomatic flare in 32% of both arms, with no reduction from proactive home fecal calprotectin monitoring versus standard care. The trial compared scheduled home monitoring with usual follow-up to assess whether planned biomarker checks during remission changed later flare outcomes.

The study enrolled adults with ulcerative colitis in remission, defined by a modified partial Mayo score of 2 or less and no rectal bleeding. Participants were randomized to standard care or fecal calprotectin testing every 2 months for 18 months or until symptomatic flare, with confirmatory testing within 2 weeks when values reached 250 micrograms per gram or higher; treatment changes remained at physician discretion. Among 716 enrolled patients, 611 were analyzed, including 308 in the control arm and 303 in the intervention arm; mean age was 42 years and 47% were men. Disease extent was similarly distributed, 45% were receiving advanced therapy, and end points included symptomatic flare, health care use, medication use, and quality of life.

Time to symptomatic flare was the primary end point, and the median time to flare was not reached during follow-up. The hazard ratio for symptomatic flare was 1.05, with a 95% confidence interval from 0.79 to 1.40. Flare risk did not differ overall, by disease extent, or by advanced therapy use, and secondary outcomes for health care use, medication use, and quality of life were also similar between groups. Overall, results were consistently null across the reported outcomes.

Among 88 patients who changed therapy after confirmatory elevated fecal calprotectin testing, flare frequency was numerically lower at 49% versus 55%, but flare risk was not different. That subgroup observation did not change the overall trial result. The authors concluded that proactive home-based fecal calprotectin monitoring without protocolized escalation did not prevent symptomatic flares. They added that further studies are needed to define optimal use of fecal calprotectin monitoring and clarify any benefit of earlier intervention.