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.

Research Finds Fungus Associated With Crohn’s Disease

Researchers have a new understanding of why some people develop Crohn’s disease: fungi.

A study led by researchers from Case Western Reserve University School of Medicine has found that fungus is a key factor in the development of Crohn’s disease. Previous studies have shown that bacteria, genes, and diet all play factors in causing Crohn’s disease. The findings were published in mBio.

“Essentially, patients with Crohn’s have abnormal immune responses to these bacteria, which inhabit the intestines of all people,” senior author Mahmoud A Ghannoum, PhD, professor and director of the Center for Medical Mycology at Case Western Reserve and University Hospitals Cleveland Medical Center, said in a statement. “While most researchers focus their investigations on these bacteria, few have examined the role of fungi, which are also present in everyone’s intestines.”

The researchers studied the mycobiome and bacteriome of patients with Crohn’s and in their first-degree relatives who did not have Crohn’s, plus families in the area that did not have Crohn’s. The researchers found strong fungal-bacterial interactions in those with Crohn’s disease. The 2 bacteria and 1 fungus found worked together to produce a biofilm that can cause the inflammation the leads to Crohn’s symptoms.

This study represents the first time fungus has been linked to Crohn’s disease in humans. Dr. Ghannoum believes that the findings may lead to a new generation of treatments that can make a real difference in the lives of people with Crohn’s.

Less than a week after the findings were released, the Food and Drug Administration approved another treatment for Crohn’s disease: Stelara. The drug is approved to treat moderately to severely active Crohn’s disease in adults who failed or were intolerant to treatment with immunomodulators or corticosteroids.

“Because of the individual nature of these diseases, what works for one patient may not work for another. That is why it is so critical that our Crohn’s patients have many different treatment options available to them,” Michael Osso, president and CEO of the Crohn’s & Colitis Foundation of America, said in a statement.

He added that with Stelara approved, many patients with moderate-to-severe Crohn’s disease who have exhausted available treatments have another option to hopefully induce remission, help manage their disease, and improve their quality of life.