The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new data from the Phase 3 UNIFI maintenance study evaluating ustekinumab for ulcerative colitis. The data showed that a significantly greater proportion of adults with moderate to severe ulcerative colitis (UC) receiving ustekinumab subcutaneous (SC) maintenance therapy were in clinical remission at Week 44, compared to patients receiving placebo – the study’s primary endpoint. Patients receiving ustekinumab SC maintenance therapy had a clinical response eight weeks after receiving a single intravenous (IV) dose of ustekinumab.
These data were presented as part of a plenary session (Abstract OP37) at the 14th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Copenhagen, Denmark. At the Congress, Janssen also shared a digital oral presentation with additional data from the UNIFI induction study evaluating the effects of ustekinumab on histo-endoscopic mucosal healing (HEMH), a novel, pre-specified endpoint in this programme.
Results from the maintenance phase of the Phase 3 study demonstrated that 44% (90mg every eight weeks [q8w]) and 38% (90mg every 12 weeks [q12w]) of patients with moderate to severe UC receiving ustekinumab SC injections achieved clinical remission, as defined by the Mayo score, at week 44 (52 weeks after IV induction) compared to 24% of patients who received placebo (p<0.001 and p=0.002, respectively). These data were included in submissions to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) seeking approval of ustekinumab as a treatment for UC.