Randomized, controlled trial of recombinant human interleukin‐11 in patients with active Crohn's disease

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Abstract
Background: Interleukin‐11 is a mesenchymally derived cytokine with pleiotropic activities. A pilot study suggested therapeutic benefit of recombinant human interleukin‐11 (rhIL‐11) in patients with Crohn's disease.Aim: To determine the safety and preliminary estimate of efficacy of rhIL‐11 in treating active Crohn's disease.Methods: Patients with mild to moderately active Crohn's disease, defined as a Crohn's disease activity index (CDAI) ≥ 220 and ≤ 450, were enrolled in a multicentre trial. Stable doses of 5‐aminosalicylates, antibiotics, 6‐mercaptopurine or azathioprine were permitted with appropriate wash‐in periods. Oral, intravenous or rectally administered corticosteroids were not allowed. Patients were randomized to 6 weeks of subcutaneous injection with rhIL‐11 15 μg/kg or placebo weekly, or rhIL‐11 7.5 μg/kg or placebo twice weekly. The primary end‐point was per cent change in CDAI at week 6; the major secondary end‐point was the proportion of patients in remission, defined as a 100 point decrease in CDAI and absolute CDAI ≤ 150.Results: Baseline characteristics were similar among the 148 evaluated patients (49 placebo, 49 rhIL‐11 15 μg/kg once weekly, 50 rhIL‐11 7.5 μg/kg twice weekly). Treatment was well‐tolerated, with mild injection site reactions occurring more frequently among patients treated with rhIL‐11. Headache, oedema, and increased platelet count occurred significantly more often in the rhIL‐11 7.5 μg/kg twice weekly group, but not the 15 μg/kg once weekly group. There was a trend toward decreased mean per cent change in CDAI in the rhIL‐11 15 μg/kg once weekly group vs. placebo (–31.5% vs. – 18.5%, 95% confidence interval for the difference – 27.9–1.6%). A significantly greater proportion of patients receiving rhIL‐11 15 μg/kg once weekly achieved remission compared to placebo (36.7% vs. 16.3%, 95% confidence interval for the difference 3.4–37.4%; 16.4% for rhIL‐11 7.5 μg/kg, N.S.).Conclusions: Weekly subcutaneous injection with rhIL‐11 15 μg/kg is safe and effective in inducing remission in a subset of patients with active Crohn's disease.

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