Multiple sclerosis: 5 more brain bleeds reported with alemtuzumab

Takeaway

• 5 additional cases of intracranial hemorrhage have been identified in patients with multiple sclerosis (MS) receiving alemtuzumab (Lemtrada).

Why this matters

• Alemtuzumab is efficacious for treating relapsing-remitting MS, as a first-line option or after disease-modifying therapy.
• FDA issued a safety communication about 13 cases of ischemic or hemorrhagic stroke and cervical arterial dissection associated with alemtuzumab.

Key results

• 5 patients experienced spontaneous hemorrhage during the initial 5-day course of alemtuzumab.
• Patients had no history of bleeding disorder, stroke, intracranial hemorrhage, aneurysm, or hypertension.
• Patients were not receiving antihypertensives, anticoagulants, platelet inhibitors.
• During infusions, 4 patients reported headache and 1 patient reported chest tightness and neck pain that resolved.
• Hemorrhages occurred after receiving 3-5 doses of alemtuzumab, all several hours after leaving the infusion center.
• Locations: 4 in basal ganglia, 1 in frontal lobe.
• All patients admitted to intensive care unit.
• Recovery:
  • 2 patients had no residual deficits.
  • 3 patients had considerable neurologic sequelae.
• Measurements leading up to last infusion showed upward trend of mean systolic blood pressure (15.0%-54.7% increase) in 4 patients, lability during infusion in 1 patient.

Study design

• Retrospective review of patients treated at 4 US MS centers.
• Main outcome: characteristics.
• Funding: None disclosed.

Limitations

• Reliance on records.
• Variation in treatment.