title: Randomized, double blind controlled trial of subcutaneous recombinant human interleukin-11 versus prednisolone in active Crohn's disease.
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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Robert-Bosch-Hospital, Stuttgart, Germany.
authors.forename: Klaus R
authors.initials: KR
authors.lastname: Herrlinger
authors.forename: Thomas
authors.initials: T
authors.lastname: Witthoeft
authors.forename: Andreas
authors.initials: A
authors.lastname: Raedler
authors.forename: Bernd
authors.initials: B
authors.lastname: Bokemeyer
authors.forename: Thomas
authors.initials: T
authors.lastname: Krummenerl
authors.forename: Jorg-Dieter
authors.initials: JD
authors.lastname: Schulzke
authors.forename: Norbert
authors.initials: N
authors.lastname: Boerner
authors.forename: Bruno
authors.initials: B
authors.lastname: Kueppers
authors.forename: Joerg
authors.initials: J
authors.lastname: Emmrich
authors.forename: Axel
authors.initials: A
authors.lastname: Mescheder
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schwertschlag
authors.forename: Mark
authors.initials: M
authors.lastname: Shapiro
authors.forename: Eduard F
authors.initials: EF
authors.lastname: Stange
mesh_terms: D000284:Administration, Oral; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D017370:Interleukin-11 / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D017370:Interleukin-11; D011994:Recombinant Proteins; D011239:Prednisolone; C105308:oprelvekin