Fernando Magro, MD, PhD, is head of clinical pharmacology at University Hospital São João.

Fernando Magro, MD, PhD

From Induction to Year 4: Mirikizumab’s Lasting Impact in Ulcerative Colitis

Long-term findings from the LUCENT clinical program continue to strengthen the case for mirikizumab (Omvoh) as a potential disease-modifying therapy in moderately-to-severely active ulcerative colitis (UC).

Data presented at the 21st Congress of European Crohn’s and Colitis Congress (ECCO) demonstrate the p19-directed interleukin (IL)-23 monoclonal antibody’s sustained efficacy and safety through 212 weeks of continuous treatment across the LUCENT-1 (induction), LUCENT-2 (maintenance), and LUCENT-3 (open-label extension) trials.

Mirikizumab was approved for the treatment of UC in 2023 based on LUCENT program data from a pair of trials, UC-1 , a 12-week induction study, and UC-2, a 40-week maintenance study. Most recently, the US Food and Drug Administration approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of mirikizumab for subcutaneous use in adults with UC after demonstrating bioequivalence to the previously approved 2-injection regimen.

Study investigator Fernando Magro, MD, PhD, head of clinical pharmacology at University Hospital São João, noted that the LUCENT program’s design mirrors the real-world management of UC, allowing investigators to evaluate not only early response but durability and impact on hard clinical outcomes.

Preventing UC-related hospitalizations and surgeries is a key goal outlined in SPIRIT consensus recommendations for disease-modification trials. During LUCENT-1, patients randomized to intravenous mirikizumab 300 mg every 4 weeks demonstrated lower rates of UC-related hospitalizations and surgeries compared with placebo. Those who achieved clinical response at week 12 and continued on subcutaneous mirikizumab 200 mg every 4 weeks in LUCENT-2 maintained those reductions, with no UC-related hospitalizations or surgeries reported in the mirikizumab-treated group during maintenance.

Of note, the durability of benefit extended into LUCENT-3. Among 316 patients entering the open-label extension, representing 835 patient-years of exposure, a single UC-related hospitalization was reported over 3 years, corresponding to an exposure-adjusted incidence rate of 0.1 per 100 patient-years. No UC-related surgeries were observed. Taken together, Magro says these results suggest sustained suppression of disease activity over 4 years of continuous treatment.

“It is amazing that we are changing the outcome and the natural history of ulcerative colitis with mirikizumab,” he said.

Magro additionally emphasized that early achievement of endoscopic and histo-endoscopic mucosal improvement after induction was closely linked to improved 1-year outcomes. Patients who reached remission at 1 year experienced stability over time, with no reported hospitalizations or surgeries through 4 years. Such durability, Magro noted, signals more than short-term symptom control—it suggests modification of the disease course itself.

The concept of “disease clearance,” encompassing endoscopic remission, histologic remission, and absence of symptoms, further underscores this shift, with roughly 60% of patients achieving this deep remission at 1 year and many maintaining it long term.

Given the significant morbidity associated with colectomy and the profound impact hospitalizations and surgery have on quality of life, Magro says sustained reductions in these outcomes represent a meaningful advance.

Editors’ note: Magro reports relevant disclosures with Abbvie, Arena, Biogen, Bristol-Myers Squibb, Falk, Ferring, Hospira, Janssen, Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp & Dohme, Sandoz, Takeda, UCB, and Vifor.

Magro F, Ananthakrishnan A, Kobayashi T, et al. Mirikizumab treatment decreases Ulcerative Colitis-related surgery and hospitalisation rates: 4-year LUCENT studies results. Presented at 21st Congress of European Crohn’s and Colitis Congress (ECCO), February 18–21, 2026, Stockholm, Sweden.

Campbell P. FDA Approves Mirikizumab (Omvoh) for Ulcerative Colitis. HCPLive. October 26, 2023. Accessed February 26, 2026. 

https://www.hcplive.com/view/fda-approves-mirikizumab-omvoh-for-ulcerative-colitis

Livingston R. FDA Approves Single-Dose Formulation of Mirikizumab-mrkz for Ulcerative Colitis. HCPLive. October 27, 2025. Accessed February 26, 2026. 

https://www.hcplive.com/view/fda-approves-single-dose-formulation-of-mirikizumab-mrkz-for-ulcerative-colitis

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4-year LUCENT data show mirikizumab reduces UC-related hospitalizations and surgeries, supporting durable remission and potential disease modification.

Fernando Magro, MD, PhD

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