Johnson & Johnson (J&J) has announced that Stelara (ustekinumab) has been approved by the European Commission (EC) to treat moderately to severely active Crohn’s disease (CD) in paediatric patients.
The drug, which is already approved in the EU to treat CD in adults, is now authorised for use in paediatric patients who weigh at least 40kg and have had an inadequate response, or been intolerant, to either conventional or biologic therapy.
CD is one of the two main forms of inflammatory bowel disease (IBD), which is estimated to affect nearly two million people across Europe. While CD is more commonly diagnosed in adults, approximately 25% of cases are diagnosed during childhood or adolescence.
CD can cause a range of symptoms, including abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever, and paediatric patients can also experience growth delays due to essential nutrients not being properly absorbed by the small intestine.
Stelara is a monoclonal antibody designed to block the activity of the interleukin 12 and interleukin 23 molecules in the immune system, which are involved in inflammation and other processes that drive CD.
The drug is also approved in the EU to treat certain cases of ulcerative colitis, the other main type of IBD, as well as plaque psoriasis and psoriatic arthritis.
The EC’s latest decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage UNITI-Jr trial, in which 52.1% of paediatric patients achieved clinical remission after eight weeks, with clinical responses observed as early as week three.
After 44 weeks, 43.5% of paediatric patients receiving Stelara 90mg every every weeks and 60% of those receiving Stelara 90mg every 12 weeks achieved clinical remission, with 22.7% and 28% achieving endoscopic response, respectively.
Data from the REALITI real-world evidence study also supported the approval.
The authorisation comes just days after J&J’s Tremfya (guselkumab) was recommended by the Committee for Medicinal Products for Human Use to treat moderately to severely active CD in adults. The EC will now review the recommendation as it makes a final decision on Tremfya.