Positive Results From Phase 3 Stelara Trial for Crohn’s Disease

Data from Phase 3 of the UNITI-2 study showed that treatment with Stelara, from Johnson & Johnson, successfully induced clinical response and remission in patients with moderate to severe Crohn’s disease.

Patients who participated had previously failed conventional therapy and those treated with Stelara demonstrated higher rates of clinical response at week 6 compared with placebo. Stelara is currently approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis, but it is believed that the cytokines the therapy targets plays a role in immune-mediated diseases, such as Crohn’s disease.

“Findings from this Phase 3 program provide an important first look into the efficacy and safety of Stelara induction therapy in the treatment of inflammatory bowel disease—a disease where new therapeutic options are needed as the incidence continues to rise globally,” Brian Feagan, MD, professor of medicine, chief executive officer, and senior medical director at Robarts Research Institute, University of Western Ontario, and study investigator, said in a statement.

Participants in the trial received either a single intravenous infusion of placebo, or Stelara 130 mg or 6 mg/kg (weight-tiered dosing). At week 6, 52% of Stelara 130 mg and 56% receiving the weight-tiered dosing had a reduction from baseline in the Crohn’s Disease Activity Index score of at least 100 points compared with 29% on the placebo.

The study also found that patients dosed with Stelara had significant improvements in signs and symptoms, in the Inflammatory Bowel Disease Questionnaire, and markers of inflammation.

Adverse events and infections reported occurred in similar proportions across the Stelara and placebo groups and no malignancies, deaths, opportunistic infections, cases of tuberculosis, or major adverse cardiovascular events were observed in Stelara patients.

“The Stelara Phase 3 UNITI-2 induction results are important findings, as induction of clinical response and clinical remission are important goals in the management of Crohn’s disease,” Newman Yeilding, MD, head of Immunology Development at Janssen Research & Development, LLC, said.

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