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Data from the Phase III UNIFI maintenance study announced at ECCO 2019

18 March, 2019  
Janssen has announced new data from the Phase III UNIFI maintenance study. 
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.1 Patients receiving ustekinumab SC maintenance therapy had a clinical response 8 weeks after receiving a single intravenous (IV) dose of ustekinumab.1
Results from the maintenance phase of the Phase III study demonstrated that 44% (90mg every 8 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).1 These data were included in submissions to the European Medicines Agency and the US Food and Drug Administration seeking approval of ustekinumab as a treatment for UC.
Ulcerative colitis is a disruptive, lifelong and potentially debilitating inflammatory bowel disease; however, it is a condition where remission is possible,” said lead study investigator William Sandborn, MD, Chief, Division of Gastroenterology and Professor of Medicine, University of California, San Diego. “The data suggest the potential of ustekinumab as an effective therapy for helping people living with ulcerative colitis achieve remission, as well as providing other meaningful outcomes, including clinical response, histo-endoscopic improvement and corticosteroid-free remission.”
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 ustekinumab q8w and q12w injections versus patients receiving placebo. At week 44:
  • 71% of patients receiving ustekinumab q8w and 68% of patients receiving ustekinumab q12w maintained clinical response, compared with 44% of patients receiving placebo (both p<0.001).1 Clinical response was defined as a decrease from baseline in the Mayo score by ≥30% and ≥3 points, with a rectal bleeding sub-score of 0 or 1 or a decrease in the rectal bleeding sub-score ≥1.
  • 51% of patients receiving ustekinumab q8w and 44%of patients receiving ustekinumab q12w achieved endoscopic improvement, compared with 29% of patients receiving placebo (p<0.001 and p=0.002, respectively).1 Endoscopic improvement was defined as a Mayo endoscopy sub-score of 0 (normal mucosa or inactive disease) or 1 (mild disease activity)
  • 42% of patients receiving ustekinumab q8w and 38 percent of patients receiving ustekinumab q12w were in clinical remission and were corticosteroid-free, compared with 23% of patients receiving placebo (p<0.001 and p=0.002, respectively).1 The global remission definition was a Mayo score ≤2 points, with no individual sub-score >1.
Through to week 44, the proportions of patients with adverse events (AEs), serious AEs, infections and serious infections in the ustekinumab groups were generally comparable to the placebo group. The proportions of patients who discontinued the study agent were lower with ustekinumab q8w and q12w versus placebo. Among the primary population in the maintenance study, no deaths occurred. Two malignancies other than non-melanoma skin cancer (NMSC) (one colon cancer, q8w; one papillary renal cell carcinoma, q12w) were reported. One patient reported NMSC (two squamous cell carcinoma events, q12w).1 Overall, the safety for ustekinumab in UC patients was consistent with the known safety profile of ustekinumab in Crohn’s disease.2
The UNIFI maintenance data further build the case for ustekinumab as a potential new treatment option for ulcerative colitis and illustrate our ongoing commitment to researching and developing meaningful therapies for people living with inflammatory bowel diseases,” said Scott E Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC. “Furthermore, we are proud that UNIFI is the first Phase III study to report a combined histo-endoscopic endpoint in patients with ulcerative colitis.”
  1. Sandborn W et al. Efficacy and safety of ustekinumab as maintenance therapy in ulcerative colitis: Week 44 results from UNIFI [Abstract OP37]. Presented at European Crohn’s and Colitis Organisation (ECCO 2019) 6-9 March, 2019; Copenhagen, Denmark.
  2. European Medicines Agency (2016) Ustekinumab Summary of Product Characteristics.…. Accessed March 2019.