A promising new option for pediatric UC: The phase 3 SHINE-2 trial found that mirikizumab (Omvoh) helped 41% of children with ulcerative colitis achieve clinical remission by week 12 — nearly triple the adult placebo rate. The drug also hit its primary endpoint at week 52, with a 50% clinical remission rate, and showed a favorable safety profile with no new concerns.
A new treatment hope for kids with ulcerative colitis
Children with ulcerative colitis (UC) have had very few advanced therapy options — until now. The phase 3 SHINE-2 trial tested mirikizumab (Omvoh, Eli Lilly), an IL-23 inhibitor, in 63 pediatric patients aged 2–17 with moderately to severely active UC. Results presented at the ACG Annual Scientific Meeting showed the drug met its primary endpoint, with 50% of week-12 responders achieving clinical remission at week 52 — matching adult outcomes from the LUCENT-1 trial.
Early results were equally encouraging. By week 12, 41% of kids achieved clinical remission (vs. 14.6% on adult placebo), and symptomatic remission kicked in as early as week 4 for over a third of patients. The safety profile was consistent with prior studies, with only two serious adverse events reported.
By the Numbers
Why it matters: With limited advanced therapies approved for pediatric UC, mirikizumab could become a much-needed addition to the treatment toolkit for young patients who have failed conventional or other advanced therapies.
