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Randomized, Double Blind Controlled Trial of Subcutaneous Recombinant Human Interleukin-11 Versus Prednisolone in Active Crohn's Disease

Herrlinger, K. R., M.D.1; Witthoeft, T., M.D.2; Raedler, A., M.D.4; Bokemeyer, B., M.D.5; Krummenerl, T., M.D.6; Schulzke, J. D., M.D.7; Boerner, N., M.D.8; Kueppers, B., M.D.9; Emmrich, J., M.D.10; Mescheder, A., M.D.4; Schwertschlag, U., M.D.3; Shapiro, M., M.D.3; Stange, E. F., M.D.1

American Journal of Gastroenterology: April 2006 - Volume 101 - Issue 4 - p 793–797

BACKGROUND Interleukin-11 has shown benefit in animal inflammatory bowel disease models. Recently, recombinant human interleukin-11 (rhIL-11) has been observed to induce remission in a subset of patients with mild to moderate Crohn's disease (CD). The present study compared the efficacy of rhIL-11 versus prednisolone in remission induction in CD.

METHODS Patients with active CD were randomly assigned to receive either subcutaneous rhIL-11 (1 mg once weekly) and prednisolone placebo tablets, or active prednisolone (60 mg/day) and rhIL-11 placebo, for 12 weeks. Prednisolone/placebo was tapered after week 1, and patients were assessed every second week.

RESULTS Fifty-one patients received medication: 13/27 (rhIL-11) and 17/24 (prednisolone) completed 12 weeks of treatment. Remission rates (intent to treat) for rhIL-11 versus prednisolone were 4%versus 46% at week 4 (p < 0.001) and 19%versus 50% at week 6 (p < 0.05). Response to treatment (ΔCDAI > 100) was seen in 19% (rhIL-11) versus 63% (prednisolone) after 4 weeks (p < 0.002) and 37%versus 63% after 6 weeks (p = 0.1). After 12 weeks of treatment, it was observed that 22% (rhIL-11) versus 21% (prednisolone) had remained in remission. Frequent side effects of rhIL-11 included fever (n = 3), rash (4), arthralgia/arthritis (3), nausea/vomiting (3), and headache (6).

CONCLUSION rhIL-11 is well tolerated but significantly inferior when compared to prednisolone in short-term remission induction in patients with active CD. In this patient cohort, both treatments appeared to be poor in maintaining remission over a period of 3 months.

1Robert-Bosch-Hospital, Stuttgart, Germany

2University of Schleswig-Holstein, Campus Luebeck, Germany

3Wyeth Research, Cambridge, Massachusetts, USA

4MediGene AG, Martinsried, Germany

5Private Gastroenterologist Practice, Minden, Germany

6Private Gastroenterologist Practice, Münster, Germany

7University Hospital Benjamin Franklin, Berlin, Germany

8Private Gastroenterologist Practice, Mainz, Germany

9Private Gastroenterologist Practice, Mannheim, Germany

10University of Rostock, Rostock, Germany

Reprint requests and correspondence: Eduard F. Stange, M.D., Department of Gastroenterology, Hepatology and Endocrinology Robert Bosch Hospital, Auerbachstrasse 110 D-70197 Stuttgart, Germany.

Received December 13, 2004; accepted January 19, 2005.

© The American College of Gastroenterology 2006. All Rights Reserved.
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