Stelara (ustekinumab) phase 3 data for ulcerative colitis released

Oct 21, 2019

Stelara® (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial. 

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented as a late-breaking data presentation (LB01) at the 27th UEGW congress.

These data include 399 participants who were in clinical response eight weeks after receiving a single intravenous (IV) induction dose of ustekinumab and who were then randomised to receive ustekinumab subcutaneous (SC) 90 mg injections every 12 weeks (q12w), ustekinumab SC 90 mg injections every 8 weeks (q8w), or placebo, and who were treated in the long-term extension.

Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission. The percentage of patients receiving ustekinumab SC who were in symptomatic remission between weeks 44 and 92 ranged from 83 to 90 percent. Among patients who had achieved clinical remission at maintenance baseline, 69 percent of patients receiving ustekinumab q8w and 80 percent of patients receiving ustekinumab q12w maintained symptomatic remission at both weeks 44 and 92. Additional analyses demonstrated that approximately 60 percent of patients receiving ustekinumab q8w and q12w achieved corticosteroid-free symptomatic remission at week 92 (64.3 percent and 63.8 percent, respectively).

Lead study investigator Bruce E. Sands, M.D., Icahn School of Medicine, Mt. Sinai, New York, who will be delivering the oral presentation said,  “Ulcerative colitis is a life-long and debilitating inflammatory bowel disease, interrupting the daily lives of millions of people around the world who may still be searching for an effective treatment option. It’s encouraging to see data from long-term extension trials that can offer symptom relief and remission over time to those struggling with UC.”

Through two years, the proportions of patients with adverse events (AEs), serious AEs, and serious infections in the ustekinumab groups were generally comparable to the placebo group. No new safety signals were observed. Ustekinumab has demonstrated a consistent safety profile in UC where trials show the treatment is well tolerated.

Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC said,“The Phase 3 UNIFI two-year data builds upon the growing body of evidence of ustekinumab as a promising treatment option for UC, further underscoring our commitment to advancing research and development in inflammatory bowel diseases. We are proud to present these results for the first time at UEGW because we recognise the significant unmet needs that continue to persist in treating the life-altering symptoms of moderately to severely active UC.”

Janssen is presenting a total of 17 abstracts at this year’s UEGW congress, of which seven are oral presentations, including additional data from the UNIFI UC clinical trials programme. Another late-breaker on UNIFI data reports results from the maintenance study by individual ustekinumab IV induction dose and suggests an optimal regimen of IV induction and SC maintenance for the treatment of moderately to severely active UC (LB07).

Ustekinumab is currently approved for the treatment of adults with moderately to severely active ulcerative colitis in the European Union (EU) and the United States.