Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in adult patients who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
Stelara, an interleukin (IL)-12 and interleukin-23 antagonist, is the only treatment for Crohn’s disease that initiates with a weight-based one-time intravenous (IV) infusion induction dose, followed by subcutaneous (SC) maintenance injections every 8 weeks. It is the first biologic treatment for Crohn’s disease that targets the IL-12 and IL-23 cytokines. Stelara is already indicated to treat adults with active psoriatic arthritis, alone or in combination with methotrexate; and to treat moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.
The FDA approval was based on data from clinical studies of over 1,300 patients who were either new to, experienced with, or failed biologic therapy. The program included three Phase 3 studies: UNITI-1 induction study, UNITI-2 induction study, and the IM-UNITI maintenance study.
The data showed between 34% (UNITI-1 study) and 56% (UNITI-2 study) of patients had relief from Crohn’s disease symptoms in just 6 weeks after receiving the 1-time IV infusion of Stelara. Also, noticeable improvement was seen as soon as 3 weeks. Among patients who responded to the induction dosing and continued treatment with Stelara SC maintenance doses every 8 weeks experienced remission at the end of 44 weeks.
Stelara is available as 45mg/0.5mL and 90mg/1mL strength solutions in single-use vials and single-use prefilled syringes.
For more information call (800) 526-7736 or visit StelaraInfo.com.