SHINE-2 and Closing the Pediatric UC Treatment Gap, With Marla Dubinsky, MD

Mirikizumab induction produced early clinical, endoscopic, and symptomatic improvements in children and adolescents with moderately to severely active ulcerative colitis (UC), according to week 12 results from the phase 3 SHINE-2 study. The late-breaking findings were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee.1

At week 12, 41.3% of participants aged 2 to 17 years achieved clinical remission, and 81.0% achieved clinical response.1

Marla Dubinsky, MD, of the Icahn School of Medicine at Mount Sinai, told HCPLive the results move pediatric patients one step closer to the first approved interleukin (IL)-23p19 inhibitor for UC. Today, only infliximab, adalimumab, and ustekinumab carry pediatric UC approvals, with ustekinumab added in August 2026.3

“Pediatric patients deserve the same sort of attention, and I would even argue a little bit more, when it comes to advanced therapies, because of the repercussions of ongoing inflammation on growth,” said Dubinsky.

Off-Label Use and the Pediatric UC Treatment Gap

Dubinsky noted ustekinumab was approved for adults with Crohn’s disease in 2016, but pediatric approval did not follow until 2026. No IL-23p19 inhibitors, sphingosine-1-phosphate receptor modulators, or Janus kinase inhibitors are approved for children with UC, leaving clinicians to prescribe off label.

She added children often present with more aggressive disease, estimating 8 in 10 pediatric patients with UC have pancolitis at diagnosis. Without pediatric trials, clinicians must estimate dosing for smaller patients, particularly those weighing less than 40 kg.

SHINE-2 Design and Weight-Based Mirikizumab Dosing

SHINE-2 enrolled 63 participants with a modified Mayo score of 5 to 9 and an endoscopic subscore of 2 or higher.1 Participants received weight-based intravenous induction every 4 weeks for 3 doses (300 mg if more than 40 kg; 5 mg/kg if 40 kg or less), followed by subcutaneous maintenance every 4 weeks at 200 mg, 100 mg, or 50 mg by weight.

Investigators compared pediatric outcomes with historical results from the adult phase 3 LUCENT program.1,2 Dubinsky said the phase 2 SHINE-1 study established dosing, while SHINE-2 confirmed mirikizumab exposures with weight-based dosing were generally comparable across weight groups and with adults.

Week 12 Clinical, Endoscopic, and Symptomatic Outcomes in Children

At week 12, pediatric rates exceeded historical adult placebo rates for clinical remission (41.3% vs 14.6%), clinical response (81.0% vs 43.4%), endoscopic remission (25.4% vs 4.5%), and endoscopic improvement (50.8% vs 21.0%). PUCAI remission was achieved by 58.7%, and PUCAI response by 87.3%.1

Symptomatic remission was observed in 38.1% of participants by week 4 and in 69.8% by week 12. Mean fecal calprotectin fell from 3734 µg/g at baseline to 1649 µg/g at week 12. By week 52, 50.0% of week 12 clinical responders were in clinical remission, comparable to the adult mirikizumab rate of 50.7%.1

Through week 12, adverse events were mild or moderate, and serious adverse events occurred in 3.2% of participants.1 A single participant discontinued because of a UC flare, and no new safety concerns were identified.

Prior Advanced Therapy Exposure and Long-Term Pediatric Data

About half of SHINE-2 participants had prior exposure to advanced therapies, mirroring the refractory populations in adult trials. Dubinsky said this gives clinicians evidence to support IL-23 inhibition in children who have not responded to other agents.

“What the clinical trials do is help validate what we have been doing off label and give us the confidence that what we’re seeing in the clinic is something that’s seen in the trial, and vice versa,” said Dubinsky.

Week 52 results were presented at United European Gastroenterology Week 2026, and Eli Lilly and Company plans to submit the data to global regulators.4 Participants can continue into the SHINE-ON long-term extension.1

References:

1. Dubinsky MC, Bousvaros A, Griffiths AM, et al. Mirikizumab induction therapy achieves early clinical, endoscopic, and biomarker improvement in children and adolescents with moderately to severely active ulcerative colitis: week 12 results from the SHINE-2 study. Presented at: American College of Gastroenterology 2026 Annual Scientific Meeting; October 9-14, 2026; Nashville, TN.

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. FDA approves Stelara for pediatric ulcerative colitis. US Food and Drug Administration. August 2026. Accessed October 30, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-stelara-pediatric-ulcerative-colitis

4. 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 30, 2026. https://www.biospace.com/press-releases/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