Janssen's Stelara in another phase 3 Crohn's success
Janssen's Stelara (ustekinumab) induced clinical response and clinical remission in adults with moderate to severe Crohn's disease, who had failed or were intolerant to one or more anti-TNF drugs, according to phase 3 data.
The Johnson & Johnson unit's phase 3 UNITI-1 study, which included 741 people with Crohn's disease, met primary endpoint, with Stelara treatment groups demonstrating significantly higher rates of clinical response at week six compared with placebo group.
Results published at the European Crohn's and Colitis Organisation (ECCO) congress in Amsterdam, showed secondary endpoints of clinical response at week eight and clinical remission at week eight were also significantly higher among patients receiving Stelara compared with placebo.
Findings follow phase 3 results from the UNITI-2 study showing efficacy and safety of Stelara in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF therapy.
At week six, 34% of patients receiving Stelara 130mg and 34% receiving Stelara ~6mg/kg achieved clinical response, compared with 22% of patients receiving placebo. Clinical response at week eight was 34% and 38% in the 130mg and ~6mg/kg groups respectively, and 20% in the placebo group.
At week eight, 16% of patients receiving Stelara 130mg and 21% of patients receiving Stelara ~6mg/kg achieved clinical remission, compared with 7% of patients receiving placebo. Response and remission was assessed using the Crohn's Disease Activity Index score.
Serious adverse events were reported in similar proportions across Stelara and placebo treatment groups. One case of listeria meningitis was reported in the Stelara 6mg/kg group. No malignancies, deaths, cases of tuberculosis of major adverse events were observed in the Stelara group, according to the results.
Regulators in the EU and US are reviewing Stelara in severely active Crohn's disease. Stelara is already approved for moderate to severe plaque psoriasis in many countries, and is a monoclonal antibody targeting interleukin (IL)-12 and IL-23 cytokines.
These are believed to play a role in immune-mediated diseases, including Crohn's.