FDA Approves Once-Monthly Mirikizumab Regimen for Ulcerative Colitis as Real-World Data Shows Early Treatment Benefits
Key Insights
The FDA has approved a new once-monthly single-injection maintenance regimen of mirikizumab-mrkz (search) (Omvoh) for treating moderately to severely active ulcerative colitis (search) following positive Phase 1 bioequivalence results.
Real-world data from 142 patients reveals that more than a quarter of ulcerative colitis (search) patients initiated mirikizumab without prior advanced therapy, indicating clinicians' growing comfort with earlier treatment positioning.
Oral corticosteroid prescriptions declined by more than half (from 67.6% to 28.2%) within three months of mirikizumab initiation, suggesting improved disease control and meaningful steroid-sparing benefits.
The U.S. Food and Drug Administration has approved a new once-monthly single-injection maintenance regimen of mirikizumab-mrkz (search) (Omvoh; Eli Lilly and Company) for treating moderately to severely active ulcerative colitis (search), while new real-world data demonstrates the therapy's effectiveness across diverse patient populations, including those receiving it as first-line advanced therapy.
The FDA approval followed positive results from a Phase 1 study demonstrating bioequivalence between the new regimen and a previously approved regimen. The maintenance therapy with mirikizumab is designed to follow induction with three 300-milligram intravenous infusions received once every four weeks.
Real-World Evidence Shows Broad Clinical Adoption
A retrospective, observational study presented at Crohn's & Colitis Congress provides the first real-world snapshot of mirikizumab use in U.S. clinical practice. The study analyzed 142 adults with ulcerative colitis (search) (mean age 41.8 years; 51.4% women) who initiated mirikizumab between October 26, 2023, and July 2025, using administrative claims from the HealthVerify database.
"This study offers the first real-world snapshot of U.S. patients receiving mirikizumab, revealing its use across diverse patients, including those advanced treatment-naive and heavily pretreated," said Jordan Axelrad, MD, MPH, a gastroenterologist at NYU Langone Health's Inflammatory Bowel Disease Center.
Treatment Positioning and Patient Characteristics
The real-world data revealed that 26.9% of patients had not received any prior advanced therapy before initiating mirikizumab, indicating clinicians' increasing comfort with positioning the therapy earlier in the treatment course. Among patients with prior advanced therapy exposure, 54.2% had received one advanced therapy, 16.2% had received two, and 2.8% had received three or more.
At baseline, the most common comorbidities were anemia (search) (26.1%), abdominal pain (20.4%), and hypertension (search) (18.3%). Approximately two-thirds (67.6%) of patients used oral corticosteroids (search) and 45.1% used 5-aminosalicylate (search) prior to initiating mirikizumab. Among those with prior advanced therapy experience, 59.2% had used biologics, 23.2% had used Janus kinase inhibitors, and 2.8% had used sphingosine-1-phosphate receptor modulators.
Significant Corticosteroid-Sparing Benefits
The study demonstrated substantial improvements in disease management following mirikizumab initiation. Oral corticosteroid prescriptions declined dramatically from 67.6% to 28.2% in the three months following treatment initiation, suggesting improved disease control.
"Gastroenterologists should recognize that mirikizumab shows very meaningful corticosteroid-sparing benefits when used both early and after multiple advanced treatment failures," Axelrad noted, though he emphasized that most early prescribers still positioned use later in the therapy sequence.
Safety Considerations
Clinicians are advised to monitor patients for common adverse effects of mirikizumab, including headaches, joint pain, injection-site reactions, upper respiratory infections, and hepatic enzyme elevations.
Mirikizumab is an anti-interleukin-23p19 (search) monoclonal antibody approved in the United States for the treatment of both ulcerative colitis (search) and Crohn's disease (search). The agent previously demonstrated sustained efficacy and safety among patients with moderately to severely active ulcerative colitis in the LUCENT trials.
The real-world evidence helps contextualize how mirikizumab fits into current treatment algorithms beyond the controlled environment of clinical trials, providing valuable insights for gastroenterologists considering optimal treatment sequencing for their ulcerative colitis (search) patients.