Use of anti-ICAM-1 therapy in ischemic stroke--Results of the Enlimomab Acute Stroke Trial Export

@article{sherman01use, abstract = {1: Neurology. 2001 Oct 23;57(8):1428-34. Links Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial.Enlimomab Acute Stroke Trial Investigators. BACKGROUND: There has been recent interest in the possible role of reperfusion-induced inflammation with neuronal injury after stroke. Enlimomab, a murine intercellular adhesion molecule-1 (ICAM-1) antibody, reduces leukocyte adhesion and infarct size in experimental stroke studies. The purpose of the current clinical trial was to evaluate the use of enlimomab after ischemic stroke. METHODS: A total of 625 patients with ischemic stroke were randomized to receive either enlimomab (n = 317) or placebo (n = 308) within 6 hours of stroke onset. Treatment was given over 5 days. Patients were evaluated at baseline and on days 5 and 90 after initiation of treatment; long-term assessments were carried out after 6 and 12 months. The primary efficacy endpoint was the response to therapy at 90 days on the Modified Rankin Scale; other endpoints included Barthel Index (BI) and NIH Stroke Scale and survival. RESULTS: At day 90, the Modified Rankin Scale score was worse in patients treated with enlimomab than with placebo (p = 0.004). Fewer patients had symptom-free recovery on enlimomab than placebo (p = 0.004), and more died (22.2 versus 16.2\%). The negative effect of enlimomab was apparent on days 5, 30, and 90 of treatment (p = 0.005). There were significantly more adverse events with enlimomab treatment than placebo, primarily infections and fever. Patients experiencing fever were more likely to have a poor outcome or die. CONCLUSIONS: The authors conclude that anti-ICAM therapy with enlimomab is not an effective treatment for ischemic stroke in the model studied and, indeed, may significantly worsen stroke outcome. PMID: 11673584 [PubMed - indexed for MEDLINE]}, author = {Sherman, D. G. and Bes, A. and Easton, J. D. and Hacke, W. and Kaste, M. and Polmar, S. H. and Zivin, J. A. and Fieschi, C. and Miller, P. and Schoenfeld, D. and Others}, citeulike-article-id = {3815943}, journal = {Neurology}, keywords = {icam}, number = {8}, pages = {1428--1434}, posted-at = {2008-12-21 18:52:57}, priority = {2}, title = {Use of anti-ICAM-1 therapy in ischemic stroke--Results of the Enlimomab Acute Stroke Trial}, volume = {57}, year = {2001} }

TY - JOUR ID - sherman01use L3 - citeulike-article-id:3815943 N2 - 1: Neurology. 2001 Oct 23;57(8):1428-34. Links Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial.Enlimomab Acute Stroke Trial Investigators. BACKGROUND: There has been recent interest in the possible role of reperfusion-induced inflammation with neuronal injury after stroke. Enlimomab, a murine intercellular adhesion molecule-1 (ICAM-1) antibody, reduces leukocyte adhesion and infarct size in experimental stroke studies. The purpose of the current clinical trial was to evaluate the use of enlimomab after ischemic stroke. METHODS: A total of 625 patients with ischemic stroke were randomized to receive either enlimomab (n = 317) or placebo (n = 308) within 6 hours of stroke onset. Treatment was given over 5 days. Patients were evaluated at baseline and on days 5 and 90 after initiation of treatment; long-term assessments were carried out after 6 and 12 months. The primary efficacy endpoint was the response to therapy at 90 days on the Modified Rankin Scale; other endpoints included Barthel Index (BI) and NIH Stroke Scale and survival. RESULTS: At day 90, the Modified Rankin Scale score was worse in patients treated with enlimomab than with placebo (p = 0.004). Fewer patients had symptom-free recovery on enlimomab than placebo (p = 0.004), and more died (22.2 versus 16.2%). The negative effect of enlimomab was apparent on days 5, 30, and 90 of treatment (p = 0.005). There were significantly more adverse events with enlimomab treatment than placebo, primarily infections and fever. Patients experiencing fever were more likely to have a poor outcome or die. CONCLUSIONS: The authors conclude that anti-ICAM therapy with enlimomab is not an effective treatment for ischemic stroke in the model studied and, indeed, may significantly worsen stroke outcome. PMID: 11673584 [PubMed - indexed for MEDLINE] IS - 8 JF - Neurology EP - 1434 TI - Use of anti-ICAM-1 therapy in ischemic stroke--Results of the Enlimomab Acute Stroke Trial VL - 57 SP - 1428 KW - icam AU - Sherman, DG AU - Bes, A AU - Easton, JD AU - Hacke, W AU - Kaste, M AU - Polmar, SH AU - Zivin, JA AU - Fieschi, C AU - Miller, P AU - Schoenfeld, D AU - Others PY - 2001/// ER -