Stelara Reduces Risk of Hospitalization, Surgery for Crohn’s Patients, New Phase 3 Data Show

Stelara Reduces Risk of Hospitalization, Surgery for Crohn’s Patients, New Phase 3 Data Show
Stelara (ustekinumab) can reduce the risk of Crohn’s disease-related hospitalization and surgery, according to new two-year Phase 3 results announced by Janssen, the therapy's maker. This new analysis of long-term data from the ongoing Phase 3 IM-UNITI extension trial (NCT01369355) was presented at the 2018 Digestive Disease Week meeting, recently held in Washington, D.C. The abstract was titled “Reduced rates of Crohn’s- related surgeries, hospitalizations and alternate biologic initiation with ustekinumab in the IM-UNITI study through 2 years.” “Crohn’s disease can have a significant impact on patients, with most having multiple relapses and many experiencing complications that require intervention. These long-term data from IM-UNITI are particularly encouraging for clinicians as they demonstrate that treatment with ustekinumab [Stelara] reduced the need for hospitalisation, surgery, or a switch to another treatment,” William Sandborn, MD, gastroenterology chief at UC San Diego Health System and a study investigator, said in a press release. IM-UNITI, a randomized, double-blind, placebo-controlled, parallel group study, evaluated the effectiveness and safety of Stelara maintenance therapy in 1,282 adult patients with moderate to severe Crohn’s disease at 220 centers worldwide. Patients who had responded to a single dose of Stelara in the UNITI-1 (NCT01369329) or UNITI-2 (NCT01369342) induction studies were randomized to three groups, receiving either a maintenance dose of 90 mg every eight weeks, or every 12 weeks, or a placebo. Patients who responded well to the treatment at week 44 of the IM-UNITI trial could enter the long-term extension part of the study, currently ongoing, up to 252 weeks. Completion of the study is expected in
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