Marla C. Dubinsky, MD: Measuring Urgency in Ulcerative Colitis

An absence of urgency was associated with greater reductions in levels of inflammatory biomarkers C-reactive protein and fecal calprotectin in a cohort of patients treated with mirikizumab.

The absence of urgency could be a useful metric in gauging colonic inflammation in patients with ulcerative colitis.

In data presented during the 2021 American College of Gastroenterology (ACG) Annual Meeting, a team led by Marla C. Dubinsky, MD, Professor of Pediatrics, Icahn School of Medicine at Mount Sinai, found patients with the absence of urgency had significantly greater reductions in levels of inflammatory biomarkers C-reactive protein (CRP) and fecal calprotectin (fCLP) in a cohort of patients treated with mirikizumab.

In the study, 249 patients were equally randomized to receive intravenous placebo, 50 or 200 mg mirikizumab with exposure-based dose increase possibility or fixed mirikizumab 600 mg every 4 weeks.

The 106 patients who achieved clinical response were then re-randomized into a double-blind maintenance study with either 200 mg mirikizumab subcutaneously every 4 or 12 weeks through 52 weeks.

In an interview with HCPLive®, Dubinsky explained how the results show clinicians should pay attention to urgency as a useful metric for patient severity.

Dubinsky also said clinical trials for inflammatory bowel disease should start to focus more on targeting endpoints such as urgency or the lack of urgency.