Fingolimod (Gilemya) shows promise in treatment of intracerebral hemorrhage

1. Treatment with fingolimod reduced perihematomal edema (PHE) and reduced the numbers of circulating lymphocytes in patients with intracerebral hemorrhage (ICH).

2. 100% of patients treated with fingolimod achieved a reduction in neurologic impairment and an improvement in Glasgow coma scale (GCS) score of 15 by day 7. 

Evidence Rating Level: 2 (Good)           

Study Rundown: ICH is associated with high rates of morbidity and mortality.  Inflammatory cascades activated by the initial hematoma accelerate the formation of perihematomal edema (PHE), which peaks in size in 5-6 days and exacerbates mass effect and cell death.  Previous therapies have focused on reducing cerebral edema but no therapies have tried to alter this destructive inflammatory cascade.  Fingolimod (FTY720, Gilemya), a Sphingosine 1-phosphate receptor modulator that reduces lymphocyte migration into the brain, is currently FDA approved for the treatment of relapsing form of multiple sclerosis.  In addition, it also penetrates the CNS and acts directly on neural and glial cells. These properties have in fact been shown to improve short and long term outcomes in rat models.

In this evaluator-blinded, proof-of-concept study, patients admitted to Tianjin Medical University General Hospital with ICH either received standard management or standard management + fingolimod.  Patients treated with fingolimod saw a reduction in circulating lymphocytes, PHE volume, improvement in Glasgow Coma Scale (GCS) score and NIH stroke score as compared to patients receiving standard therapy.  Limitations of the study include the fact that only 23 patients were included in the study.  As this is a proof-of-concept trial, further expanded trials need to be performed to reach any conclusions on fingolimod’s efficacy.

Click to read the study, published today in JAMA Neurology

Relevant Reading: Intracerebral haemorrhage: mechanisms of injury and therapeutic targets

In-Depth [proof-of-concept study]:  After screening 220 patients, 23 patients with primary supratentorial ICH with hematomal volume between 5 to 30 mL, whose symptom onset was less than 72 hours prior to admission, and GCS score of more than 6,  were included in the trial.  Patients either received standard therapy or fingolimod orally for three consecutive days in addition to standard therapy. Clinical assessments were performed by two neruologists who were blinded to treatment.

As noted above, patients treated with fingolimod had a reduction in neurologic impairment with improvement in the GCS score to 15 by day 7 as compared to the control group (100% vs. 50%, p=. 01).  At 3 months, more patients receiving fingolimod achieved full recovery of neurologic function (modified ranking scale score range, 0-1; 63% vs. 0%; p = .001).  PHE volume was also significantly smaller in the fingolimod-treated group.  No differences were observed in the rates of adverse events between the groups.

Image: PD

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