Preliminary evaluation of safety and activity of recombinant human interleukin 11 in patients with active Crohn's disease

B. E. Sands*, S. Bank, C. A. Sninsky, M. Robinson, S. Katz, J. W. Singleton, Jr Miner P.B., M. A. Safdi, S. Galandiuk, S. B. Hanauer, G. W. Varilek, A. L. Buchman, V. D. Rodgers, B. Salzberg, B. Cai, J. Loewy, M. F. Debruin, H. Rogge, M. Shapiro, U. S. Schwertschlag

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

198 Scopus citations

Abstract

Background and Aims: Recombinant human interleukin 11 (rhIL-11) is a cytokine with thrombocytopoietic activity and anti-inflammatory and mucosal protective effects. The objectives of this study were to investigate the safety and tolerability of rhIL-11 in patients with Crohn's disease and to explore the effects of dose and schedule on platelet count and Crohn's disease activity. Methods: A multicenter, double-masked, placebo-controlled, dose-escalation study of 76 patients with active Crohn's disease was performed. Patients were randomized to receive subcutaneous placebo or rhIL- 11 at doses of 5, 16, or 40 μg · kg-1 · wk-1 given 2 or 5 times weekly for 3 weeks. Clinical and laboratory safety data were recorded, and disease activity was measured at each visit. Results: Subcutaneous injection of rhIL- 11 generally was well tolerated. Significantly greater increases in platelet counts were found among patients receiving rhlL-11 40 μg · kg-1 · wk- 1 as 2 or 5 weekly doses and 16 μg · kg-1 · week-1 as 5 weekly doses compared with patients receiving placebo (P ≤ 0.05). Patients receiving 16 μg · kg-1 · wk-1 had the highest clinical response rates, with a response seen in 42% of patients (5/12) receiving 5 weekly doses and 33% of patients (4/12) receiving 2 weekly doses, compared with 7% of patients (1/15) receiving placebo. Conclusions: Short-term treatment with rhIL-11 is well tolerated in patients with active Crohn's disease. The thrombocytopoietic effect of rhIL-11 seems to be both dose and schedule dependent and may be minimized with retained clinical benefit in Crohn's disease at 16 μg · kg- 1 μ wk-1 given in 2 equal doses.

Original languageEnglish (US)
Pages (from-to)58-64
Number of pages7
JournalGastroenterology
Volume117
Issue number1
DOIs
StatePublished - Jan 1 1999

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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