02 Nov Ulcerative Colitis: FDA Approves Mirikizumab After Study Finds Long Lasting Response
MedicalResearch.com Interview with:
Dr. Dubinsky
Marla C. Dubinsky, MD
Professor of Pediatrics and Medicine
Icahn School of Medicine at Mount Sinai
Co- director, Susan and Leonard Feinstein IBD Clinical Center
Mount Sinai Health System
MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of UC?
Response: Lucent 1 and Lucent 2 were the induction and maintenance registration trials studying the efficacy and safety of mirikizumab in patients 18 years and older with moderate to severely active ulcerative colitis. Mirikizumab is a monoclonal antibody targeting the p19 subunit of IL23. Lucent-3 is the open label extension arm for those meeting inclusion criteria after completing Lucent 2. This study evaluated the long term efficacy and safety of mirikizumab in patients with ulcerative colitis who completed a total of 104 weeks of active mirikizumab treatment.
Ulcerative colitis is a chronic incurable inflammatory condition of colon. Common symptoms include diarrhea, blood in the stool, abdominal cramping and bowel urgency. Bowel urgency is one of the most burdensome symptoms that a patient with you could experience.
MedicalResearch.com: How does mirikizumab differ from other treatments/biologics for UC?
Response: Mirikizumab is a member of the class of therapies that blocks the IL-23 cytokine which is unique compared to most other approved UC therapies. The only exception is ustekinumab which targets both IL-23 and IL-12. One important outcome that is unique to the mirikizumab trial is the objective measure of bowel urgency severity using the urgency Numeric Rating Scale and reporting bowel urgency remission as a key secondary endpoint.
MedicalResearch.com: What are the main findings?
Response: Approximately 3/4 of patients who completed the initial 52 weeks as responders or remitters continued to respond at week 104 suggesting long term durable treatment effect with less than 3% of patients discontinuing therapy due to an adverse event. Additionally more than half of the patients demonstrated key outcomes such as endoscopy and bowel urgency remission. Of note these longer term outcomes were not impacted by prior biologic failures.
MedicalResearch.com: What should readers take away from your report?
Response: Mirikizumab has shown efficacy in both the blinded and open label phase of the Lucent program highlighting the durability of mirikizumab in the treatment of ulcerative colitis.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: This long term extension study data will continue to report on the durability and safety of mirikizumab. Real world effectiveness studies would add more data from clinical practice.
Disclosures: Marla Dubinsky, MD from the Susan and Leonard Feinstein IBD Center, Icahn School of Medicine, is an advisor and consultant for Lilly , the sponsors of the trial and is an author on the publication and member of trial steering committee
Citations:
2: FDA Approves Lilly’s Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
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