Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis
Bruce E Sands1, William J Sandborn1, Remo Panaccione1
1From the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Division of Gastroenterology, University of California, San Diego, La Jolla (W.J.S.), and the F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles (S.T.) - both in California; the Departments of Medicine and Community Health Sciences, University of Calgary, Calgary, AB, Canada (R.P.); Janssen Research and Development, Spring House, PA (C.D.O., H.Z., J.J., O.J.A., K.L., P.S., C.M.); the Gastroenterology Department and INSERM 1256, Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France (L.P.-B.); the Division of Gastroenterology and Hepatology, University Hospitals Leuven and Translational Research Center for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium (G.V.A.); the IBD Center, Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan (S.D.); the Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami (M.T.A.); and the Division of Gastroenterology, Third Department of Internal Medicine, Kyorin University School of Medicine, Tokyo (T.H.).
Ustekinumab effectively induced and maintained clinical remission in moderate-to-severe ulcerative colitis patients. This interleukin-12/23 antagonist demonstrated superior efficacy compared to placebo with a similar safety profile.
Area of Science:
- Immunology
- Gastroenterology
- Pharmacology
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
- The efficacy of ustekinumab, an interleukin-12 and -23 antagonist, for UC is not well-established.
- Targeting IL-12/23 pathways offers a potential therapeutic strategy for UC.
Purpose of the Study:
- To evaluate ustekinumab's efficacy as induction and maintenance therapy in moderate-to-severe ulcerative colitis.
- To determine the optimal dosing regimen for ustekinumab in UC patients.
- To assess the safety and tolerability of ustekinumab in this patient population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 961 patients with moderate-to-severe UC.
- Patients received ustekinumab or placebo for 8-week induction therapy.
- Responders to induction therapy were randomized to receive maintenance therapy with ustekinumab (every 8 or 12 weeks) or placebo for 44 weeks.
- Clinical remission was defined by the Mayo score.
Main Results:
- Ustekinumab significantly increased clinical remission rates at week 8 (15.6% vs 5.3%) and week 44 (38.4%-43.8% vs 24.0%) compared to placebo.
- Serious adverse events were similar between ustekinumab and placebo groups.
- Long-term safety data showed a low incidence of deaths and cancers.
Conclusions:
- Ustekinumab is an effective treatment for inducing and maintaining remission in moderate-to-severe ulcerative colitis.
- The study supports ustekinumab as a valuable therapeutic option for UC patients.
- Further research may explore long-term outcomes and specific patient subgroups.
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