Janssen’s ulcerative colitis treatment shows positive results in phase 3 trials
pharmafile | March 13, 2019 | News story | Manufacturing and Production, Research and Development | Jansenn, Stelara, phase 3 trials, ulcerative colitis
Janssen’s ulcerative colitis treatment, Stelara (ustekinumab subcutaneous) has shown positive results as maintenance therapy in phase 3 trials.
The study found that 44% of patients with severe to moderate ulcerative colitis who took 90mg of Stelara every eight weeks and 38% of those who took 90mg every 12 weeks achieved clinical remission as defined by the Mayo score, at week 44 compared to 24 percent of patients who received placebo.
“Ulcerative colitis is a disruptive, lifelong and potentially debilitating inflammatory bowel disease; however, it is a condition where remission is possible,” lead study investigator Dr William Sandborn, Chief, Division of Gastroenterology and Professor of Medicine, University of California, San Diego, said.
“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.”
Overall, 71% of those receiving ustekinumab every eight weeks and 68% of those taking Jansenn’s drug every 12 weeks maintained clinical response compared with 44% taking a placebo. The number of patients reporting adverse events was generally comparable to placebo.
“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 Dr Scott E. Plevy, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC.
“Furthermore, we are proud that UNIFI is the first Phase 3 study to report a combined histo-endoscopic endpoint in patients with ulcerative colitis.”
Louis Goss
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