New Phase 3 data on Stelara (ustekinumab) in Ulcerative Colitis

New Phase 3 data on Stelara^® (ustekinumab) in Ulcerative Colitis was presented on Saturday at the 14th Congress of the European Crohn’s and Colitis Organisation (ECCO) in Copenhagen.

The data showed that a significantly greater proportion of adults with moderate-to-severe ulcerative colitis receiving subcutaneous maintenance ustekinumab were in clinical remission at Week 44, compared to patients receiving placebo – the study’s primary endpoint.

Results demonstrated that 44% (90 mg every 8 weeks [q8w]) and 38% (90 mg every 12 weeks [q12w]) of patients with moderate to severe ulcerative colitis receiving ustekinumab subcutaneous 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 the submissions to the EMA seeking approval of ustekinumab as a treatment for ulcerative colitis.

Janssen also presented additional data from the UNIFI induction study evaluating the effects of ustekinumab in histo-endoscopic mucosal healing, a novel, pre-specified endpoint in this programme.

Patients achieved higher rates of endoscopic improvement, histologic improvement and the combined endpoint of histo-endoscopic mucosal healing (HEMH) vs placebo, 8 weeks after receiving a single IV induction dose of ustekinumab.
Histo-endoscopic mucosal healing assesses how the colon is responding both histologically and endoscopically to therapy and both have been associated with improved long-term clinical outcomes, such as risk of relapse and need for surgery/hospitalisation, and reduced risk of developing cancer.

A number of inflammatory bowel disease learning zones are available to view for more information and resources: Inflammatory Bowel Disease Assessment Tools, Anti-integrins in Inflammatory Bowel Disease.