FDA approval for Stelara to treat moderately to severely active ulcerative colitis.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA approval of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase III UNIFI clinical trial which achieved its primary endpoint of clinical remission.

Results from UNIFI demonstrate that treatment with Stelara both induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active ulcerative colitis (UC) compared to placebo. The pivotal trial included an initial Induction study (UNIFI-I) where patients received a single dose of Stelara 6 mg/kg intravenous (IV) infusion. It was followed 8 weeks later by a Maintenance study (UNIFI-M) where patients received Stelara 90 mg subcutaneous (SC) injections every 8 weeks for 44 weeks. Both studies demonstrated the safety and efficacy of Stelara as a treatment option for patients with moderately to severely active UC, and the design and complete results were recently published in the New England Journal of Medicine.

In the Induction study, 19 percent of patients receiving Stelara achieved clinical remission in just 8 weeks. In addition, Stelara provided patients with rapid relief of their symptoms as 58 percent of patients receiving Stelara experienced a clinical response at Week 8. In the Maintenance study, 45 percent of patients receiving Stelara were in remission at one year. Stelara also helped patients achieve clinical remission without the use of corticosteroids. At 1 year, 43 percent of patients treated with Stelara were in clinical remission and not receiving steroids.

Stelara is the first and only approved UC treatment to provide improvement of the intestinal lining as assessed by a novel histologic-endoscopic mucosal improvement endpoint. In the Induction study, 17 percent of patients receiving Stelara achieved histologic-endoscopic mucosal improvement at Week 8. In the Maintenance study, 44 percent of patients receiving Stelara achieved histologic-endoscopic mucosal improvement at 1 year. Histologic-endoscopic mucosal improvement is a combined measure that assesses the improvement of the colon at the cellular level through histologic examination and through images observed during colonoscopy. The relationship of histologic-endoscopic mucosal improvement to long-term outcomes was not studied in the clinical trial..