Mirikizumab meets 1-year remission end point in pediatric UC

Half of children and adolescents with moderately to severely active ulcerative colitis (UC) who responded to mirikizumab (Omvoh; Eli Lilly and Company) induction were in clinical remission after 1 year, according to phase 3 SHINE-2 data presented as a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain.¹ The single-arm, open-label study met its primary end point, and Lilly plans to submit the data to global regulators to support a pediatric label expansion.¹

Marla C. Dubinsky, MD, chief of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children's Hospital in New York and a paid consultant for Lilly, said the corticosteroid-free remission result was "particularly meaningful, especially in a population where many patients had previously experienced treatment failure" with advanced therapies.¹

SHINE-2 trial design and 1-year mirikizumab efficacy in pediatric UC

SHINE-2 enrolled 63 patients aged 4 to 17 years; 54% had prior biologic treatment failure, and half had severe disease on the Pediatric Ulcerative Colitis Activity Index.¹ Patients received weight-based intravenous induction every 4 weeks for 3 doses (300 mg if >40 kg; 5 mg/kg if ≤40 kg).¹

At week 12, 81% achieved clinical response, and 52 responders aged 6 to 17 years continued weight-based subcutaneous maintenance every 4 weeks through week 52.¹ Without a control arm, the primary end point was tested against a benchmark derived from the adult placebo remission rate in phase 3 LUCENT-2; the lower bound of the 80% credible interval for pediatric remission (42.8%) exceeded the upper bound of the 90% credible interval for the adult placebo rate (32.6%).¹

At week 52, 50% of responders were in clinical remission, 50% were in corticosteroid-free clinical remission without surgery, 73.1% maintained clinical response, and 71.2% were in symptomatic remission.¹ Endoscopic improvement occurred in 53.8% and endoscopic remission in 44.2%.¹

Mirikizumab safety in children and adolescents with UC

Through week 52, safety among all 63 enrolled patients was consistent with the adult profile.¹ The most common treatment-emergent adverse events were upper respiratory tract infection, injection site reaction, UC, headache, nasopharyngitis, and anemia, mostly mild to moderate.¹ Four patients (6.3%) had serious adverse events, none considered treatment related, and 2 (3.2%) discontinued because of UC flare.¹ No deaths, malignancies, opportunistic infections, or growth-related concerns were reported.¹

Burden of pediatric-onset ulcerative colitis and unmet treatment needs

Pooled US claims data estimate that more than 26,000 children and adolescents in the United States live with UC.³ Pediatric-onset disease is often more extensive and severe than adult-onset UC, and corticosteroid dependence and colectomy remain common outcomes, according to the 2025 ESPGHAN/ECCO consensus guideline.⁴ Dubinsky noted that each year of corticosteroid reliance or surgical risk carries implications for growth, development, and quality of life.¹

IL-23p19 inhibition and mirikizumab approvals in adults

Mirikizumab is a humanized monoclonal antibody that selectively targets the p19 subunit of IL-23, a cytokine implicated in inflammatory bowel disease pathogenesis.¹ In the adult LUCENT-2 maintenance trial, 49.9% of induction responders receiving mirikizumab were in clinical remission at week 40 vs 25.1% with placebo.² The agent is approved for moderately to severely active UC and Crohn disease in adults in 47 countries; safety and effectiveness have not been established in pediatric patients.¹

Limitations of SHINE-2 and next steps for pediatric IBD

The absence of a randomized pediatric control arm is the central limitation, as efficacy was judged against an adult-derived benchmark.¹ Week 52 efficacy was reported only for induction responders, and the sample is too small to detect uncommon adverse events. The data have not yet been published in a peer-reviewed journal. Patients completing SHINE-2 may enter the SHINE-ON long-term extension (NCT04844606), and a phase 3 study in pediatric Crohn disease (NCT05509777) is ongoing.¹

References

1. Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year phase 3 results in pediatric ulcerative colitis. News release. Eli Lilly and Company. October 19, 2026. Accessed October 19, 2026. https://lilly.mediaroom.com/2026-10-19-Lillys-Omvoh-mirikizumab-mrkz-meets-primary-endpoint-of-clinical-remission-and-is-the-first-IL-23p19-inhibitor-to-report-one-year-Phase-3-results-in-pediatric-ulcerative-colitis

2. D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940

3. Kappelman MD, Brensinger C, Parlett LE, Hurtado-Lorenzo A, Lewis JD. Prevalence of pediatric inflammatory bowel disease in the United States: pooled estimates from three administrative claims data sources. Gastroenterology. 2025;168(5):980-982.e2. doi:10.1053/j.gastro.2024.11.004

4. Wine E, Aloi M, Van Biervliet S, et al. Management of paediatric ulcerative colitis, part 1: ambulatory care—an updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation. J Pediatr Gastroenterol Nutr. 2025;81(3):765-815. doi:10.1002/jpn3.70097