Janssen has announced positive outcomes from their 2-year, long-term extension (LTE) study of subcutaneous (SC) Stelara (ustekinumab) as treatment for adult patients with moderately to severely active Crohn’s disease. The data was presented at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO).
The Phase 3 ‘IM-UNITI’ trial was intended to examine the safety and efficacy of ustekinumab maintenance therapy in patients with moderately to severely active Crohn’s disease, and enrolled 1,281 patients with the disease. Of these, 397 achieved a response to ustekinumab at week 8 following an induction period.
These 397 patients were then randomized to receive SC ustekinumab 90mg every 8 weeks (Q8W) or every 12 weeks (Q12W), or placebo during a maintenance (0–44 week) period, before entering the LTE (44–252 week) period.
Clinical efficacy data was collected every 12 weeks and safety data every 4 weeks from the end of the maintenance period until the maintenance study was unblinded, and then at Q8W or Q12W dosing visits. Among randomized patients who entered the LTE period and continued to receive ustekinumab through week 96, 79.2% of patients receiving ustekinumab Q12W and 87.1% of patients receiving ustekinumab Q8W were in remission, while 90.9% of patients and 94.3% of patients showed clinical response at week 92, respectively.
Among all ustekinumab-treated patients who continued to receive ustekinumab through week 96, remission and response rates at week 92 were 70.7% and 84.7%, respectively (as observed).
“We look forward to sharing future results from the UNITI program, and remain committed to improving overall outcomes for people living with Crohn’s disease,” said Frederic Lavie, therapeutic area leader immunology, cardiovascular and metabolics at Janssen.
Stelara, an interleukin-12 and interleukin-23 antagonist, is currently approved to treat 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, failed or were intolerant to treatment with ≥1 TNF blockers; active psoriatic arthritis; and moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.
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