Janssen announced new data from the phase 3 UNIFI maintenance study (N=523) which evaluated ustekinumab subcutaneous (SC) maintenance therapy in adults with moderate to severe ulcerative colitis (UC). The full data were presented at the 14th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Copenhagen, Denmark.
Participants were randomized to placebo (N=175), UST 90mg SC every 8 weeks (N=176), or every 12 weeks (N=172). Compared to placebo, treatment with ustekinumab resulted in a significantly greater proportion of adults with moderate to severe UC achieving clinical remission at week 44 (primary endpoint).
Specifically, 43.8% of patients receiving SC ustekinumab 90mg every 8 weeks (P<.001) and 38.4% of patients receiving SC ustekinumab 90mg every 12 weeks (P=.002) achieved clinical remission, compared with 24.0% of patients receiving placebo. Maintenance of clinical response through week 44 was seen in 71.0.%, 68.0%, and 44.6% of patients, respectively.
Also, a greater proportion of patients in the ustekinumab arm achieved major secondary endpoints at week 44 including maintenance of clinical response, endoscopic improvement, corticosteroid-free remission, and maintenance of clinical remission from baseline, compared with the placebo arm.
Regarding safety, both ustekinumab arms and the placebo arm demonstrated similar proportions of adverse events (AEs), serious AEs, infections, and serious infections.
Additional study data on the effects of ustekinumab on histo-endoscopic mucosal healing (HEMH) were also presented at the meeting. Compared with placebo, ustekinumab-treated patients experienced higher rates of endoscopic improvement, histologic improvement, and the combined HEMH endpoint, 8 weeks after receiving a single IV induction dose of ustekinumab.
“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,” stated lead study investigator William Sandborn, MD, Chief, Division of Gastroenterology and Professor of Medicine, University of California, San Diego.
Ustekinumab (Stelara), an IL-12 and IL-23 antagonist, is currently indicated to treat psoriatic arthritis, moderately to severely active Crohn disease, and moderate to severe plaque psoriasis.
For more information visit Stelara.com.