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CDAI scores decreased by 136 (112) at week 14 versus 52 (107) for placebo (p=0.027) and inflammatory bowel disease score questionnaire improved by 43 (31) versus 15 (36) for placebo (p=0.027).Conclusions: Although the primary outcomes failed to demonstrate efficacy, pharmacodynamic modelling suggests that alicaforsen (ISIS 2302) may be an effective therapy for steroid dependent Crohn's disease.
Patients aged 14–80 years were enrolled with moderately active (Crohn's disease activity index (CDAI) 200–350), steroid dependent Crohn's disease (active disease for ≥3 previous months despite 10–40 mg of prednisone or equivalent, with at least one unsuccessful taper attempt), documented within the previous two years and at study onset.Patients were prospectively evaluated during screening, and treatment was administered three times a week (tiw) for two or four weeks after randomisation.Patients were followed for an additional six or 12 months.Patients were stratified by baseline corticosteroid dose (low dose 10–19 mg/day; high dose 20–40 mg/day) and then tapered as follows.High dose stratum: 20 mg/day at day 8, then tapered by 2.5 mg/week beginning on day 15; low dose stratum: maintain baseline dosage and then taper by 2.5 mg/week to maintain dosage by study week with high dose stratum.These subjects received doses of up to 2 mg/kg, and experienced a clinically silent dose-responsive transient increase in activated partial thromboplastin time (a PTT) and complement split product C3a (but not C5a).
A pilot study evaluated 20 subjects with moderately active Crohn's disease on corticosteroids, with or without aminosalicylates, receiving ISIS 2302 at doses of 0.5–2 mg/kg/day intravenously 13 times over four weeks.
All routine laboratory analyses were performed at Covance (Indianapolis, Indiana, USA).
Soluble ICAM-1 (s ICAM-1) levels were measured in the laboratory of Robert Rothlein Ph D (Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA) by ELISA, as previously described.
The low dose stratum patients then tapered at 2.5 mg/day per week as tolerated, so one patient could be weaned from corticosteroids by the beginning of week 10.
The primary end point was corticosteroid free remission (CDAI 70 point decrease in CDAI with corticosteroids ≤baseline dose).
Two treatment courses were administered, in months 1 and 3.