In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
Half of pediatric patients with moderately to severely active ulcerative colitis (UC) who responded to induction with mirikizumab (Omvoh) were in clinical remission after 1 year. Eli Lilly and Company presented the phase 3 SHINE-2 results as a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain.¹ Lilly said Omvoh is the first IL-23p19 inhibitor to report 1-year phase 3 results in pediatric UC.¹
Among the 52 patients who had responded by week 12, 50% reached clinical remission at week 52, meeting the primary endpoint.¹ The same share, 50%, achieved corticosteroid-free clinical remission without surgery.¹ At week 52, 73.1% of responders maintained clinical response, 71.2% were in symptomatic remission, 53.8% had endoscopic improvement, and 44.2% reached endoscopic remission.¹
“For children with ulcerative colitis, every year spent relying on corticosteroids or facing the possibility of surgery can have important implications for growth, development and quality of life,” said Marla C. Dubinsky, MD, professor of pediatrics and medicine at the Icahn School of Medicine at Mount Sinai and chief of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children’s Hospital. “Considering these challenges, the finding that half of the pediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly meaningful, especially in a population where many patients had previously experienced treatment failure with advanced therapies.”¹
SHINE-2 was a multicenter, single-arm, open-label study that enrolled 63 patients aged 4 to 17 years.¹ More than half (54%) had previously failed a biologic. Half entered the study with severe disease activity as measured by the Pediatric Ulcerative Colitis Activity Index.¹
Patients received weight-based intravenous induction every 4 weeks for 3 doses: 300 mg for patients over 40 kg and 5 mg/kg for those at or under 40 kg.¹ At week 12, 81% of patients had a clinical response,¹,³ and the 52 responders continued on weight-based subcutaneous mirikizumab every 4 weeks through week 52.¹ Week 52 efficacy was reported for these responders, who were aged 6 to 17 years. Safety was assessed in all 63 enrolled patients.¹
Subcutaneous maintenance dosing has drawn attention elsewhere in IBD. In a September 2026 BioPharm International® feature on the
Because the study had no placebo arm, the primary endpoint was measured against a prespecified benchmark derived from the adult placebo remission rate in the phase 3
Week 12 induction results were presented separately as a late-breaking oral presentation at the American College of Gastroenterology 2026 Annual Scientific Meeting on October 14, 2026.¹,³
Through week 52, safety was consistent with Omvoh’s established profile in adults, with no new safety signals identified.¹ The most common treatment-emergent adverse events were upper respiratory tract infection, injection site reaction, UC, headache, nasopharyngitis, and anemia. Most were mild to moderate.¹ Four patients (6.3%) had a serious adverse event, none of which was considered related to study treatment. Two patients (3.2%) discontinued because of a UC flare.¹ No deaths, malignancies, opportunistic infections, or growth-related safety concerns were reported.¹
Omvoh is currently approved for
Lilly plans to submit the SHINE-2 data to global regulators to support a potential pediatric UC label expansion. If approved, Omvoh would be the first IL-23p19 inhibitor indicated for pediatric UC.¹ Patients completing SHINE-2 may enroll in the long-term SHINE-ON extension study, and a separate phase 3 study of mirikizumab in pediatric Crohn disease is ongoing.¹
