Remo Panaccione, MD

Credit: Crohn's and Colitis Canada

Patients with inflammatory bowel disease (IBD) treated with mirikizumab might see statistically significant reductions in certain inflammatory biomarkers such as fecal calprotectin (fCal) and C-reactive protein (CRP).¹

A team, led by Remo Panaccione, MD, University of Calgary, Faculty of Medicine at the Cumming School of Medicine, evaluated patients with IBD treated with mirikizumab for fCal and CRP biomarkers in patients who achieve histologic and endoscopic remission, compared to a group of patients with IBD who did not achieve remission.

The data was presented during the European Crohn’s and Colitis Organization 2023 Meeting in Copenhagen.

Mirikizumab

Mirikizumab is a p19-directed IL-23 antibody that has shown promise in treating patients with moderately to severely active ulcerative colitis in the phase 3, randomized, double-blind, placebo-controlled LUCENT-1 and LUCENT-2 trials.

There is an added focus on understanding the relationship between improved histologic and endoscopic endpoints and improvement of the inflammatory biomarkers fCal and CRP in patients treated with mirikizumab.

In the study, the investigators examined data from 868 patients from the induction study receiving intravenous treatment every 4 weeks until week 12 and patients who were induction responders at week 12. The patients were rerandomized from the maintenance period receiving subcutaneous mirikizumab every 4 weeks until week 52.

The team explored the relationship between achieving histologic-endoscopic mucosal improvement (HEMI), histologic-endoscopic mucosal remission (HEMR), and improvement of fCal (≤250µg/g) and CRP (≤6mg/L) levels at week 12 and 52 using Fisher’s exact tests.

Outcomes

The results show a higher percentage of patients treated with mirikizumab achieved HEMI (n = 235) had normalized fCal (76.2%) and CRP values (88.5%), compared to patients treated with mirikizumab who did not achieve HEMI (n = 633) (21.8% and 72.7%; both P <0.001).

There was also a higher proportion of patients achieving HEMR (n = 193) with normalized fCal (76.6%) and CRP values (88%) compared to patients not achieving HEMR (n = 207) (33.8% and 63.3%; both P <0.001).

“At both [week] 12 and [week] 52, patients treated with mirikizumab who achieved HEMI or HEMR showed statistically significant improvements in fCal and CRP levels,” the investigators explained. “This suggests that CRP and fCal may be useful markers of histology and endoscopy outcomes after induction and maintenance with mirikizumab.”

References:

R Panaccione, C Sapin, F W Chan-Diehl, R E Moses, B Siegmund, A Walsh, T Kobayashi, D S Parambir, S Travis, DOP90 The association of endoscopic and histologic endpoints with fecal calprotectin and C-reactive protein in patients with moderately to severely active ulcerative colitis treated with mirikizumab, Journal of Crohn's and Colitis, Volume 17, Issue Supplement_1, February 2023, Pages i167–i169, https://doi.org/10.1093/ecco-jcc/jjac190.0130