07 Jun Stelara Found Effective in Inducing and Maintaining Remission in Crohn’s Disease
MedicalResearch.com Interview with:
William J. Sandborn, MD
Professor of Medicine and Adjunct Professor of Surgery
Chief, Division of Gastroenterology
Director, UCSD IBD Center
University of California San Diego and UC San Diego Health System
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Sandborn: The Phase 3 IM-UNITI study investigated the efficacy and safety of Stelara (ustekinumab) in the treatment of moderate to severe Crohn’s disease as an every 8 or 12 week maintenance therapy.
The study showed a significant proportion of adults with moderate to severe Crohn’s disease who received Stelara maintenance treatment achieved clinical remission.
MedicalResearch.com: What should readers take away from your report?
Dr. Sandborn: The IM-UNITI findings show the efficacy and safety of Stelara maintenance therapy in the treatment of moderate to severe Crohn’s disease.
At week 44, the study’s primary endpoint, approximately 50 percent of STELARA-treated patients achieved clinical remission, as defined by a Crohn’s Disease Activity Index (CDAI) score of less than 150 points.
STELARA demonstrated a positive benefit-to-risk profile through week 44, with adverse events reported similarly across Stelara and placebo.
IM-UNITI, together with the UNITI-1 and UNITI-2 induction studies, provides one year of data for Stelara in the treatment of Crohn’s disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Sandborn: These data show that therapy with Stelara is effective for inducing and maintaining clinical response and remission in patients with moderate to severe Crohn’s disease, both patients who have failed conventional therapy and patients who have failed biologic therapy with anti-TNF agents. More information is needed about the use of Stelara to induce and maintain endoscopic remission in Crohn’s disease, about the use of Stelara very early in the course of Crohn’s disease as so called Top Down therapy, and the use of Stelara for ulcerative colitis.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Sandborn: Results from the IM-UNITI study show the promise of Stelara as an alternative mechanism of action for the treatment of patients with moderate to severe Crohn’s disease who may be candidates for biologic therapy.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation: Abstract presented during 2016 Digestive Disease Week
Inflamm Bowel Dis. 2016 Mar;22 Suppl 1:S1. doi: 10.1097/MIB.0000000000000720.
O-001 A Multicenter, Double-Blind, Placebo-Controlled Phase3 Study of Ustekinumab, a Human IL-12/23P40 mAB, in Moderate-Service Crohn’s Disease Refractory to Anti-TFNα: UNITI-1.
Sandborn W1, Gasink C, Blank M, Lang Y, Johanns J, Gao LL, Sands B, Hanauer S, Feagan B, Targan S, Ghosh S, de Villiers W, Colombel JF, Lee S,Desreumaux P, Loftus E Jr, Vermeire S, Rutgeerts P.
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