Promising Results for Potential Stelara Expanded Indication

Janssen presented new data from the Phase 3 UNITI-2 study, showing that treatment with Stelara (ustekinumab) induced clinical response and clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy, the majority of whom were naive to treatment with anti-tumor necrosis factor (TNF)-alpha therapy.

UNITI-2, a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of Stelara induction therapy in 628 patients with moderate to severe Crohn's disease. Patients were randomized to receive a single IV infusion of placebo, Stelara 130mg or Stelara ~6mg/kg weight-tiered dosing (≤55kg: 260mg; >55kg-≤85kg: 390mg; and >85kg: 520mg) at Week 0. All patients had previously failed steroids and/or immunomodulators and were either naive to or had been exposed to anti-TNF-alpha therapy, but had not failed such biologic therapy. The primary endpoint was clinical response at Week 6, measured by the proportion of patients who achieved at least a 100-point reduction from baseline Crohn's Disease Activity Index (CDAI) scores. Major secondary endpoint at Week 8 included clinical remission defined by CDAI scores less than 150 points.

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The study achieved its primary endpoint with Stelara demonstrating significantly higher rates of clinical response at Week 6 when compared with the placebo group. At week 6, 52% of patients receiving Stelara 130mg and 56% of patients receiving Stelara ~6mg/kg achieved clinical response, compared with 29%of patients receiving placebo (P<0.001). In addition, 31% of patients receiving Stelara 130mg and 40% of patients receiving Stelara ~6mg/kg achieved clinical remission at Week 8, compared with 20% of patients receiving placebo (P=0.009 for Stelara 130mg; P<0.001 for Stelara ~6mg/kg).

Stelara is a human interleukin (IL)-12 and IL-23 antagonist currently approved, alone or in combination with methotrexate (MTX), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of active psoriatic arthritis.

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