Abstract | BACKGROUND & 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 microgram. 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 rhIL-11 40 microgram. kg-1. wk-1 as 2 or 5 weekly doses and 16 microgram. kg-1. week-1 as 5 weekly doses compared with patients receiving placebo (P < 0.05). Patients receiving 16 microgram. 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 microgram. kg-1. wk-1 given in 2 equal doses.
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Authors | B E Sands, S Bank, C A Sninsky, M Robinson, S Katz, J W Singleton, P B Miner, 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 |
Journal | Gastroenterology
(Gastroenterology)
Vol. 117
Issue 1
Pg. 58-64
(Jul 1999)
ISSN: 0016-5085 [Print] United States |
PMID | 10381910
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies
- Interleukin-11
- Recombinant Proteins
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Topics |
- Adult
- Antibodies
(analysis)
- Crohn Disease
(therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Interleukin-11
(administration & dosage, adverse effects, immunology, therapeutic use)
- Male
- Middle Aged
- Recombinant Proteins
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