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.