Results from a long-term Crohn’s disease study.
Janssen-Cilag International reported results from its ongoing IM-UNITI long-term extension (LTE) clinical trial assessing the efficacy and safety of subcutaneous (SC) Stelara (ustekinumab) in patients with moderate to severe Crohn’s disease.
The company, a division of Johnson & Johnson, presented the study’s two-year results at the 12th Congress of the European Crohn’s and Colitis Organisation, and demonstrated that patients treated with Stelara maintained clinical response and remission for up to two years.
“Maintaining control of disease symptoms is paramount in the treatment of Crohn’s disease,” William Sandborn, MD, chief of gastroenterology at University of California-San Diego Health System, said in a press release. “The two-year clinical response and remission rates from the IM-UNITI study provide further evidence that ustekinumab can be an effective therapeutic option for people living with this chronic and often debilitating disease.”
The IM-UNITI maintenance study (NCT01369355) evaluated patients who achieved clinical response eight weeks after a single intravenous infusion of Stelara in two Phase 3 trials: UNITI-1 (NCT01369329) and UNITI-2 (NCT01369342). More than half of patients receiving Stelara by injection every eight weeks were in clinical remission after almost one year of treatment.
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