Alimentary TractRecombinant human interleukin 10 in the treatment of patients with mild to moderately active Crohn's disease☆,☆☆,★
Section snippets
Patients
Patients older than 18 years had a diagnosis of mild to moderately active Crohn's disease of the ileum and/or colon and a Crohn's Disease Activity Index (CDAI) score11 between 200 and 350 during the week before study drug initiation. None were receiving corticosteroids or immunosuppressive agents. The CDAI incorporates 8 variables related to the disease: number of liquid or very soft stools, severity of abdominal pain or cramping, general well-being, presence of extraintestinal manifestations,
Patient enrollment
The intent-to-treat data set comprised 95 patients at 25 of 27 participating centers of whom 72 were randomized to rhuIL-10 and 23 to placebo. The distribution among the 4 doses of rhuIL-10 was as follows: 18 patients received 1 μg/kg, 17 received 5 μg/kg, 18 received 10 μg/kg, and 19 received 20 μg/kg. No more than 6 patients were enrolled at any 1 center at each dose level.
Twelve patients (rhuIL-10 groups [n = 10] and placebo [n = 2]) did not complete the 28-day treatment phase, including
Discussion
This study assessed the effects of subcutaneous rhuIL-10 in patients with Crohn's disease. The effect of rhuIL-10 was assessed in adult patients with mild to moderately active Crohn's disease, currently relapsing but not receiving either corticosteroid, mesalamine, or immunosuppressive therapy.
rhuIL-10 was safe and well tolerated. Patient-reported adverse clinical events were mild flu-like symptoms, which were dose-related and reversible. Any serious adverse clinical event reported by patients
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Address requests for reprints to: Richard N. Fedorak, M.D., Division of Gastroenterology, University of Alberta, 519 Robert Newton Research Building, Edmonton, Alberta, Canada T6G 2C2. e-mail: [email protected]; fax: (403) 407-3744.
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Supported by Schering-Plough Research Institute (Kenilworth, New Jersey).
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The Interleukin 10 Inflammatory Bowel Disease Cooperative Study Group consists of the following centers and investigators [the number of patients enrolled at each center is given in brackets]: Richard N. Fedorak, M.D., University of Alberta, Edmonton, Alberta, Canada [23]; Alfred Gangl, M.D., and Christoph Gasche, M.D., University Clinic for Internal Medicine IV, Vienna, Austria [9]; Charles O. Elson, M.D., University of Alabama at Birmingham, Birmingham, Alabama [6]; Paul Rutgeerts, M.D., UZ Gasthuisberg, Leuven, Belgium [6]; Stefan Schreiber, M.D., Universitatsklinikum Charite, Berlin, Germany [6]; Gary Wild, M.D., McGill University, Montreal, Quebec, Canada [5]; Steven B. Hanauer, M.D., University of Chicago, Chicago, Illinois [4]; Charles A. Sninsky, M.D., University of Florida, Gainesville, Florida [4]; John H. P. Wilson, M.D., University Hospital Rotterdam, The Netherlands [4]; Herbert Tilg, M.D., University Clinic of Internal Medicine, Innsbruck, Austria [3]; Kim Isaacs, M.D., University of North Carolina Chapel Hill, North Carolina [3]; Meron Jacyna, M.D., Northwick Park Hospital, Harrow, England [3]; Jean-Frederic Colombel, M.D., Hopital Claude Huriez, Lille, France [3]; Sander J. H. van Deventer, M.D., Academische Medisch Centrum, Amsterdam, The Netherlands [2]; John P. Wright, M.D., Kingsbury Hospital, Cape Town, South Africa [2]; Jan Irvine, M.D., McMaster University Medical Center, Hamilton, Ontario, Canada [2]; Douglas S. Levine, M.D., Washington School of Medicine, Seattle, Washington [2]; William J. Tremaine, M.D., Mayo Clinic, Rochester, Minnesota [1]; Bret A. Lashner, M.D., The Cleveland Clinic, Cleveland, Ohio [1]; Andrew S. Warner, M.D., Lahey Hitchcock Clinic, Burlington, Massachusetts [1]; Lloyd F. Mayer, M.D., Mt. Sinai School of Medicine, New York, New York [1]; Jacob C. Koningsberger, M.D., Academisch Ziekenhuis, Utrecht, The Netherlands [1]; Andre van Gossum, M.D., Hospital Erasme, Brussels, Belgium [1]; Ranger Befrits, M.D., Karolinska Hospital, Stockholm, Sweden [1]; Kai Deusch, M.D., Klinikum der Eberhard-Karis-University, Tuebingen, Germany [1]; Stephen Targan, M.D., Cedar-Sinai Medical Center, Los Angeles, California [0]; and Peter Gibson, M.D., Royal Melburne Hospital, Victoria, Australia [0].