STELARA (ustekinumab), immunosuppressive interleukin inhibitor

In the treatment of Crohn’s disease:

Insufficient clinical benefit in patients naive to TNF inhibitors

Minor clinical added value in patients who have failed a conventional therapy (corticosteroids or immunosuppressants) and at least one TNF inhibitor.

• STELARA now has marketing authorisation in the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
• It should be restricted to patients who have failed a conventional therapy (corticosteroids or immunosuppressants) and at least one TNF inhibitor, taking into consideration its demonstrated efficacy and the identified medical need in this population.
• In patients who are naive to TNF inhibitors, its role in relation to TNF inhibitors cannot be determined because there was no direct comparison between ustekinumab and this class of medicines, although this was feasible.
• A new presentation in the form of 130 mg concentrate for solution for intravenous infusion is available only for induction treatment of CD.