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

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.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Sands BE,Bank S,Sninsky CA,Robinson M,Katz S,Singleton JW,Miner PB,Safdi MA,Galandiuk S,Hanauer SB,Varilek GW,Buchman AL,Rodgers VD,Salzberg B,Cai B,Loewy J,DeBruin MF,Rogge H,Shapiro M,Schwertschlag US

doi

10.1016/s0016-5085(99)70550-0

keywords:

subject

Has Abstract

pub_date

1999-07-01 00:00:00

pages

58-64

issue

1

eissn

0016-5085

issn

1528-0012

pii

S0016508599001146

journal_volume

117

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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