Janssen announced new data from the Phase 3 study, IM-UNITI, showing that a significantly greater proportion of adult patients with moderate to severe Crohn’s disease receiving maintenance treatment of Stelara (ustekinumab) achieved clinical remission at one year. Study findings were presented for the first time at Digestive Disease Week 2016.
IM-UNITI is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 trial that evaluated the efficacy and safety of Stelara maintenance therapy in adults with moderate to severe Crohn’s disease. The study, including 388 treatment responders of a single Stelara IV dose from the UNITI-1 or UNITI-2 induction studies, randomized patients to receive maintenance treatments of either Stelara 90mg SC every 8 weeks (Q8W), every 12 weeks (Q12W), or placebo for a combined 1 year treatment. The primary endpoint was clinical remission at Week 44, defined by a Crohn’s Disease Activity Index (CDAI; a symptom-based disease assessment tool used to quantify Crohn’s disease activity) score of less than 150 points. Major secondary endpoints at Week 44 included clinical response (patients who achieved <100-point reduction from baseline CDAI scores), clinical remission among patients in remission after induction, corticosteroid-free remission, and clinical remission in patients refractory or intolerant to anti-TNF-alpha therapies (UNITI-1 subpopulation).
Results from the maintenance study showed that clinical remission at Week 44, the study’s primary endpoint, was achieved in 53% of patients treated with Stelara 90mg SC Q8W and 49% of patients treated with Stelara 90mg SC Q12W vs. 36% of patients in the placebo group (P=0.005 and P=0.040, respectively). The secondary endpoint of clinical response was maintained in 59% of patients receiving Stelara Q8W and 58% for the Q12W dosing, compared to 44% for placebo (P=0.018 and P=0.033, respectively).
For patients in clinical remission after induction, 67% in the Q8W group and 56% in the Q12W group were in clinical remission at Week 44 vs. 46% in placebo (P<0.01; P=not significant, respectively). Corticosteroid-free remission was achieved in 47% of patients receiving Stelara Q8W and 43% in patients receiving Q12W, compared to 30% receiving placebo (P=0.004; nominal P=0.035, respectively). Clinical remission in patients refractory or intolerant to anti-TNF-alpha therapies was achieved in 41% and 39% of patients treated with Stelara 90mg Q8W and Q12W, respectively, vs. 26% treated with placebo.
Janssen submitted the Biologics License Application (BLA) for Stelara to the FDA for the moderate to severe Crohn’s disease indication in November 2015. Stelara is currently approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy and for the treatment of active psoriatic arthritis in adults, as monotherapy or in combination with methotrexate (MTX).
Stelara is a human interleukin (IL)-12 and IL-23 antagonist.
For more information (800) 526-7736 or visit Janssen.com.