Randomized, double blind controlled trial of subcutaneous recombinant human interleukin-11 versus prednisolone in active Crohn's disease. The American journal of gastroenterology. [Am J Gastroenterol] Journal article | | Title | Randomized, double blind controlled trial of subcutaneous recombinant human interleukin-11 versus prednisolone in active Crohn's disease. | | Author(s) | Herrlinger KR, Witthoeft T, Raedler A, Bokemeyer B, Krummenerl T, Schulzke JD, Boerner N, Kueppers B, Emmrich J, Mescheder A, Schwertschlag U, Shapiro M, Stange EF | | Institution | Robert-Bosch-Hospital, Stuttgart, Germany. | | Source | Am J Gastroenterol 2006 Apr; 101(4):793-7. | | MeSH | Administration, Oral
Anti-Inflammatory Agents
Comparative Study
Crohn Disease
Double-Blind Method
Female
Glucocorticoids
Humans
Injections, Subcutaneous
Interleukin-11
Male
Middle Aged
Prednisolone
Recombinant Proteins
Remission Induction
Research Support, Non-U.S. Gov't
Treatment Outcome
| | Abstract | 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 (deltaCDAI > 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. | | Language | eng | | Pub Type(s) | Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 16635225 |
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