Data from phase III UNIFI study of Stelara shows remission in ulcerative colitis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase III UNIFI study showing that a significantly greater proportion of adult patients with moderate to severe ulcerative colitis (UC) receiving Stelara (ustekinumab) subcutaneous (SC) maintenance therapy were in clinical remission at one year, the study's primary endpoint, compared to patients receiving placebo. Patients receiving Stelara SC maintenance therapy were in clinical response eight weeks after receiving a single intravenous (IV) induction dose of Stelara.

Results from the maintenance phase of the Phase III study demonstrated that 44 percent of adult patients with moderate to severe ulcerative colitis receiving Stelara SC injections every 8 weeks (q8w) and 38 percent receiving Stelara SC injections every 12 weeks (q12w) achieved clinical remission, as defined by the Mayo score, at week 44 (52 weeks after IV induction), compared to 24 percent of patients who received placebo. Patients receiving Stelara had responded to a single IV induction dose. These data were included in submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of Stelara as a treatment for ulcerative colitis. Major secondary endpoints, including maintenance of clinical response, endoscopic improvement, corticosteroid-free remission and maintenance of clinical remission from baseline, were also achieved in greater proportions of patients receiving q8w and q12w injections versus patients receiving placebo. Through one year, the proportions of patients with adverse events (AEs), serious AEs, infections, and serious infections in the Stelara groups were generally comparable to the placebo group. These data were presented as part of a plenary session (Abstract OP37) at the 14th Congress of the European Crohn's and Colitis Organisation.

Comment: Stelara was filed with the FDA for ulcerative colitis in December 2018.