Richard E. Moses, D.O., J.D. Gastroenterologist, Associate Vice President, Mirikizumab Indication Lead Global Medical Affairs, Eli Lilly and Company

Ulcerative Colitis: Eli Lilly Study Finds Non-Invasive Biomarkers May Be Useful In Measuring Effectiveness of Mirikizumab Treatment Interview with:

Richard E. Moses, D.O., J.D.Gastroenterologist, Associate Vice President, Mirikizumab Indication Lead
Global Medical Affairs, Eli Lilly and Company

Dr. Moses, D.O., J.D.

Richard E. Moses, D.O., J.D.
Gastroenterologist, Associate Vice President, Mirikizumab Indication Lead
Global Medical Affairs, Eli Lilly and Company What is the background for this study? Would you briefly describe how mirikizumab works in UC? 

Response: First, this study specifically evaluated mirikizumab, a humanized IgG4 monoclonal antibody that selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of UC.

Regulatory decisions for mirikizumab as a potential treatment for adults with moderately to severely active UC in the U.S., E.U and other countries around the world are expected in 2023. If approved, mirikizumab has the potential to be the only UC treatment that selectively targets the p19 subunit of IL-23.

Gastroenterologists today benefit from having data from a range of endpoints, which can help them determine appropriate treatment options depending on their specific patients’ needs and symptoms. In addition to clinical response and clinical remission – which are often used to determine the effectiveness of a treatment – we can also use combined endpoints like histologic-endoscopic mucosal improvement (which gauges remission and treatment effectiveness), histologic-endoscopic mucosal remission (the reduction of underlying inflammation visible endoscopically) and inflammatory biomarkers faecal calprotectin (fCal) and C-reactive protein (CRP) to inform our treatment strategies.

This analysis focused on patients treated with mirikizumab from the induction study who received intravenous mirikizumab every 4 weeks until Week 12 (LUCENT-1), and patients who responded to mirikizumab during 12-week induction period who were re-randomized for the maintenance period, receiving subcutaneous mirikizumab every four weeks up to Week 40 (LUCENT-2) for 52 weeks of continuous treatment.

This study explored the relationship between achieving histologic-endoscopic mucosal improvement (HEMI), histologic-endoscopic mucosal remission (HEMR) and improvement of biomarkers fCal and CRP levels at Weeks 12 and 52. What are the main findings?

Response:  These data show that after both induction (Week 12) and maintenance (Week 52) periods, patients treated with mirikizumab who achieved HEMI or HEMR demonstrated statistically significant improvements in fCal and CRP levels, compared to those patients treated with mirikizumab who did not achieve HEMI or HEMR. What should readers take away from your report?

Response: These data show that measuring and evaluating improvements in CRP and fCal levels may be useful when treating patients. Taken together, these outcomes can help inform treat-to-target strategies for gastroenterologists in UC non-invasively.

The significance of the findings is that non-invasive biomarkers may be useful markers of endoscopy and histology. Changes in these non-invasive biomarkers could potentially help gastroenterologists managing patients with UC make decisions on whether a more invasive test, such as colonoscopy and biopsy, is necessary, or whether treatment needs to be adjusted What recommendations do you have for future research as a results of this study?

Response: The continued evaluation of a broad range of endpoints – including clinical, non-invasive biomarkers, histological and endoscopic measures, and their significance in the management of UC and long-term outcomes – will ensure scientific advancements continue to be made in evaluating treatment options for UC. This will help inform gastroenterologists in treatment approaches for their patients.

Citation:European Crohn’s and Colitis Organisation

ECCO presentation titled, “The association of endoscopic and histologic endpoints with faecal calprotectin (fCal) and C-reactive protein (CRP) in patients with moderately to severely active ulcerative colitis treated with mirikizumab.” (Full abstract linked here)

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Last Updated on March 17, 2023 by Marie Benz