Researchers at University of California San Diego School of Medicine have shown that ustekinumab, a human antibody used to treat arthritis, significantly induces response and remission in patients with moderate to severe Crohn’s disease. Results of the clinical trial will appear in the November 16 issue of the New England Journal of Medicine.
“A high percentage of the patients in the study who had not responded to conventional therapies were in clinical remission after only a single dose of intravenous ustekinumab,” said William J. Sandborn, MD, professor of medicine at UC San Diego School of Medicine and director of the Inflammatory Bowel Disease Center at UC San Diego Health. “Finding effective new treatment options for this patient population is critical because Crohn’s disease can dramatically impact a person’s quality of life. Patients suffering from this disease may go to the bathroom up to 20 times a day and experience abdominal pain, ulcers and a reduced appetite.”
Crohn’s disease is a chronic inflammatory disease of the gastrointestinal tract that affects approximately 700,000 people in the United States. It can affect any part of the GI tract but it is more commonly found at the end of the small intestine (the ileum) where it joins the beginning of the large intestine (or colon). Crohn’s disease is usually treated with glucocorticoids, immunosuppressants, tumor necrosis factor (TNF) antagonists or integrin inhibitors.
“The drawbacks of these therapies include an increased risk of infection and cancer, and limited efficacy,” said Sandborn. “Ustekinumab has not been associated with an increased risk of serious adverse events.”
The rates of remission response in the randomized study at week six among patients receiving intravenous ustekinumab at a dose of either 130 mg or approximately 6 mg per kilogram were significantly higher than the rates among patients receiving a placebo. The study also found subcutaneous (injected) ustekinumab every 8 to 12 weeks maintained remission in patients.
“This study indicates that ustekinumab may have a long duration of action, a likelihood that may become better understood in future trials,” said Sandborn. “Our current findings offer hope for those suffering from this debilitating gastrointestinal tract disease.”
The Inflammatory Bowel Disease (IBD) Center at UC San Diego Health is dedicated to diagnosing and treating people with IBD from around the world. The center’s leadership in IBD medical research means patient access to clinical trials for the newest therapies and advanced surgical techniques for the treatment of this challenging condition. Care is provided by a multidisciplinary team of specialists in gastroenterology, endoscopy, oncology, surgery, transplantation and radiology.
Co-authors of the study include: Brian Feagan, Robarts Clinical Trials, Robarts Research Institute, Western University, London; Subrata Ghosh, University of Calgary; Levinus Dieleman, University of Alberta; Stephan Targan, Cedars-Sinai Medical Center; Christopher Gasink, Douglas Jacobstein, Yinghua Lang, Joshua Friedman, Jewel Johanns, Long‑Long Gao, Ye Miao, and Omoniyi Adedokun, Janssen Research and Development; Marion Blank, Janssen Scientific Affairs; Bruce Sands, Jean‑Frédéric Colombel, Icahn School of Medicine; Seymour Katz, New York University School of Medicine; Stephen Hanauer, Feinberg School of Medicine; Severine Vermeire, Paul Rutgeerts, University of Hospitals; Willem de Villiers, Stellenbosch University; Zsolt Tulassay, Semmelweis University; Ursula Seidler, Hannover Medical School; Bruce Salzberg, Atlanta Gastroenterology Specialists; Pierre Desreumaux, Hopital Claude Huriez; Scott Lee, University of Washington Medical Center; and Edward Loftus,Jr., Mayo Clinic.
This study was funded by Janssen Research and Development (NCT01369329, NCT01369342, NCT01369355).