Findings from a late-stage clinical trial have shown that treatment with Janssen’s Stelara induced clinical response and remission in adult patients with moderate to severe Crohn’s disease refractory to TNF inhibitors, a group for whom there are little treatment options.

Crohn’s disease is a chronic inflammatory bowel disease that affects the lining of the digestive tract. Currently around 115,000 people in the UK have the condition, and while the cause is not known, it is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors.

The 741-patient, Phase III UNITI-1 study, results of which were presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO), met its primary endpoint with Stelara (ustekinumab) treatment groups demonstrating significantly higher rates of clinical response at week six when compared with the placebo group. 

At week six, 34 percent of patients receiving Stelara 130mg achieved clinical response, as defined by a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 100 points, compared with 22 percent of patients taking a placebo. At week eight, 34 percent achieved clinical response, compared with 20 percent of patients in the control arm. 

In addition, 16 percent of patients taking the drug achieved clinical remission at week eight, as defined by a CDAI score of less than 150 points, compared with 7 percent on placebo, and significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related quality of life measure for patients with IBD, as well as significant reduction in markers of inflammation, including faecal lactoferrin, calprotectin and C-reactive protein, were recorded.

On the safety side, adverse events (AEs), serious AEs and infections were reported in similar proportions across Stelara and placebo treatment groups. 

These latest findings add to Phase III results from the UNITI-2 study, which demonstrated the efficacy and safety of Stelara in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy.

“These data provide further support to the efficacy and safety of ustekinumab in Crohn’s disease. Clinicians in the United Kingdom are keen to have access to new potential therapies that can alleviate some of the symptoms experienced by patients living with this debilitating and difficult to treat condition,” said Stuart Bloom, Consultant Gastroenterologist, University College London Hospitals, commenting on the findings.

Stelara, which is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, believed to play a role in immune-mediated diseases, including Crohn’s disease. 

Janssen has already submitted an application to the European Medicines Agency seeking approval of the drug for the treatment of adult patients with moderately to severely active Crohn's disease.