Question explored with the scientific record
how about stelara for ulcerative colitis on children
The short version: no retrieved study tests Stelara in children with ulcerative colitis. The pediatric data is for Crohn's disease, and it is small.
The one pediatric trial of ustekinumab in the records enrolled 44 children aged 2 to under 18, and every one of them had Crohn's disease, not ulcerative colitis [1]. By week 16, about half responded and roughly a quarter reached clinical remission, with no clear advantage to the higher dose [1]. That is a real signal for Crohn's, and it does not transfer automatically to UC. The ulcerative colitis trial in the records (TUSCANY) tested a different drug entirely, PF-06406405, in adults with a mean age of 40 [1]. Do not let that be sold to you as pediatric UC evidence.
Safety in that pediatric Crohn's trial was not trivial: 73% had at least one adverse event, 7 had serious events, and 2 stopped the drug because of side effects [1]. Antibody formation against ustekinumab is reported as low, around 0.7% to 5.5% across adult trials [2]. Drug levels do track response in adults, but the records say the value of routinely measuring them is still uncertain [2].
| Pediatric UST trial | Value |
|---|---|
| Patients | 44, all Crohn's [1] |
| Clinical response, week 16 | 52% both dose groups [1] |
| Clinical remission, week 16 | 22% lower, 29% higher dose [1] |
| Any adverse event | 73% [1] |
| Serious adverse events | 7 total [1] |
What this retrieval cannot see: any pediatric UC trial of ustekinumab, any long-term growth or infection data in children, and any head-to-head comparison against infliximab, which does have pediatric UC trial data in these records [3]. The absence is a fact about the search, not proof the drug fails in children.
My call: for a child with UC, the evidence here does not establish that Stelara works, and the safety record in children is short. Confidence: low.
Sources used 3
-
DOP72 Safety, tolerability and efficacy of anti-TL1A antibody PF-06480605 in treatment of ulcerative colitis: The open-label, multicentre, Phase 2a TUSCANY study
Intravenous ustekinumab induction with subsequent subcutaneous maintenance yields clinically meaningful clinical and endoscopic improvement by Week 16 in paediatric Crohn's disease patients refractory to corticosteroids, immunomodulators, and anti-TNF therapy, with a safety prof…
DOI: 10.1093/ecco-jcc/jjz203.111 -
Update on TDM (Therapeutic Drug Monitoring) with Ustekinumab, Vedolizumab and Tofacitinib in Inflammatory Bowel Disease
Exposure–response relationships exist for ustekinumab, vedolizumab, and tofacitinib in inflammatory bowel disease, but the clinical utility of therapeutic drug monitoring to optimize treatment with these agents remains uncertain.
DOI: 10.3390/jcm10061242 -
Infliximab for the treatment of paediatric ulcerative colitis
This narrative review synthesizes evidence that infliximab is effective for induction and maintenance of remission in pediatric ulcerative colitis, based on retrospective studies and a phase 3 trial.
DOI: 10.1136/ejhpharm-2013-000440