Beerse, Belgium (2 April, 2025) – Johnson & Johnson today announced that the European Commission (EC) has approved a Marketing Authorisation for STELARA® (ustekinumab) to include the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.1
While Crohn’s disease is more frequently diagnosed in adults, approximately 25% of cases are diagnosed during childhood or adolescence,3 and is associated with a more extensive and severe disease course over time compared to adults.4 The onset of Crohn’s disease in paediatric patients can be triggered by various factors, including genetic susceptibility, dietary influences or other environmental triggers,5 leading to malnutrition and interference with critical periods of growth and development, which are associated with increased likelihood of mental health conditions impacting patients’ quality of life.6,7,8
The EC approval is supported by data from the Phase 3 UNITI-Jr clinical study and the real-world evidence REALITI study.9,10,11 In the UNITI-Jr study, the efficacy and safety of ustekinumab was evaluated in paediatric patients with moderately to severely active Crohn’s disease through 52 weeks of treatment: 8 weeks of induction and 44 weeks of maintenance treatment.1,9 The proportion of paediatric patients weighing at least 40 kg who achieved clinical remissiona at induction Week 8 was 52.1% (25/48), with clinical responseb observed as early as Week 3.1 In the maintenance study, at Week 44 43.5% (10/23) and 60.0% (15/25) of paediatric patients receiving ustekinumab 90 mg every 8 weeks (q8w) and every 12 weeks (q12w) achieved clinical remission, with 22.7% (5/22) and 28.0% (7/25) achieving endoscopic responsec respectively.1 Results from the real-world evidence REALITI study also supported the EC decision,11 providing evidence for the clinical effectiveness and safety of ustekinumab in routine clinical practice, comparing paediatric patients and young adults.10
The safety of ustekinumab was studied in one Phase 1 and one Phase 3 trial in paediatric patients with moderately to severely active Crohn’s disease, up to week 240 and week 52, respectively.1 Overall, the safety profile in this cohort (n = 71) was similar to previous studies in adults with Crohn’s disease.1
Editor’s Notes
a. Clinical remission is defined as CDAI score <150.1
b. Clinical response is defined as a reduction in CDAI score of ≥100 points.1
c. Endoscopic response is defined as ≥50% improvement from baseline in SES-CD score or SES-CD Score ≤2.1
ABOUT THE UNITI-Jr PROGRAMME (EudraCT 2019-004225-24)12
UNITI-Jr is a Phase 3 study evaluating the efficacy, safety, and pharmacokinetics of ustekinumab in 48 paediatric patients (aged 2-17) with moderately to severely active Crohn’s disease (defined by a Paediatric Crohn’s Disease Activity Index [PCDAI] score >30) through 52 weeks of treatment (8 weeks of induction and 44 weeks of maintenance treatment).1,9 The study included an open-label induction treatment with a single ustekinumab intravenous dose of approximately 6mg/kg, followed by a randomised double-blind subcutaneous maintenance regimen of 90mg administered either every 8 weeks or every 12 weeks.9
ABOUT CROHN’S DISEASE IN PAEDIATRIC PATIENTS
Crohn’s disease is one of the two main forms of inflammatory bowel disease (IBD), which affects nearly two million people across Europe.13 Crohn’s disease within the paediatric population is a rarer form of IBD,3 thought to be triggered through a combination of factors including genetic predisposition, diet or other environmental triggers.5 Symptoms of Crohn’s disease may include abdominal pain, rectal bleeding and weight loss,14 but for the paediatric population, Crohn’s disease can lead to malnutrition and delay growth due to essential nutrients not being properly absorbed by the small intestine.6 In paediatric IBD patients, these chronic symptoms can also lead to higher risk of mental health conditions significantly impacting quality of life.7,8 There is currently no cure for Crohn’s disease.15
ABOUT STELARA® (ustekinumab)
Ustekinumab is a fully human monoclonal antibody and is the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways.1,16 In the EU, ustekinumab is approved for the treatment of adult patients with moderate to severe Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist.1 Ustekinumab is also approved for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a biologic.1 In addition to CD and UC, ustekinumab has been approved for the treatment of two further immune-mediated conditions in the EU: plaque psoriasis (Pso) and psoriatic arthritis (PsA).1
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.innovativemedicine.jnj.com/emea. Follow us at J&J Innovative Medicine Europe, Middle East & Africa (EMEA). Janssen-Cilag International NV, Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
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CP-509895
April 2025