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Clinical Trial
. 1998 Jun;114(6):1133-42.
doi: 10.1016/s0016-5085(98)70418-4.

A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease

B R Yacyshyn  1 , M B Bowen-Yacyshyn, L Jewell, J A Tami, C F Bennett, D L Kisner, W R Shanahan Jr
Affiliations
Clinical Trial

A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease

B R Yacyshyn et al. Gastroenterology. 1998 Jun.

Erratum in

  • Gastroenterology 2001 Sep;121(3):747

Abstract

Background & aims: Intercellular adhesion molecule 1 (ICAM-1) plays an important role in the trafficking and activation of leukocytes and is up-regulated in inflamed mucosa in Crohn's disease. ISIS 2302 is an antisense phosphorothioate oligodeoxynucleotide that inhibits ICAM-1 expression. The aim of this study was to obtain preliminary assessment of tolerability, pharmacology, and efficacy of ISIS 2302 in Crohn's disease.

Methods: Twenty patients with active, steroid-treated Crohn's disease were randomized (3:1, ISIS 2302 to placebo) to receive over 26 days 13 intravenous infusions of ISIS 2302 (0.5, 1, or 2 mg/kg) or saline placebo in a double-blinded study. The patients were followed up for 6 months.

Results: At the end of treatment. 47% (7 of 15) of ISIS 2302-treated and 20% (1 of 5) of the placebo-treated patients were in remission (Crohn's Disease Activity Index [CDAI] < 150). At the end of month 6, 5 of these 7 ISIS 2302-treated remitters were still in remission, and a 6th patient had a CDAI of 156. Corticosteroid usage was significantly lower (P = 0.0001) in the ISIS 2302-treated patients. These findings were corroborated by significant increases in beta7 and alpha d bearing CD3+ peripheral blood lymphocytes and by decreases in intestinal mucosal ICAM-1 expression during the treatment period.

Conclusions: ISIS 2302 seems to be a well-tolerated and promising therapy for steroid-treated Crohn's disease.

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