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Immune Globulin Treatment for Infant Botulism

In two trials, prompt treatment with a human-derived botulism antitoxin decreased illness severity, shortened hospital stays, and reduced costs.

Infant botulism (IB) is caused by a neurotoxin that is produced in the large intestine by bacteria (generally Clostridium botulinum) ingested as spores. In the U.S., 80 to 110 IB cases are identified annually in infants presenting with flaccid paralysis. Because the equine antitoxin used for adults is not suitable for infants, treatment has been only supportive. Now, the developers of Botulism Immune Globulin Intravenous (Human) (BIG-IV), a botulinum toxin–neutralizing preparation derived from the plasma of donors immunized with pentavalent botulinum toxoid, report on its use.

An initial randomized, double-blind trial, performed in California, involved 122 infants diagnosed with IB within the previous 3 days, from February 1992 through March 1997. The infants received BIG-IV (50 mg/kg) or intravenous immunoglobulin as placebo. BIG-IV recipients showed significant reductions in mean hospital stay (2.6 vs. 5.7 weeks), hospital charges, and durations of intensive care, mechanical ventilation, and intravenous or tube feeding compared with placebo recipients. BIG-IV was not associated with any severe adverse events.

Following this trial, BIG-IV was given on an open-label basis to 382 infants nationwide diagnosed with IB within the previous 3 weeks. Again, the drug was associated with no significant adverse effects. Mean length of hospital stay was significantly shorter for infants treated within 3 days of admission than for those treated 4–7 days after admission (2.0 vs. 2.9 weeks).

Comment: These studies confirm the safety and effectiveness of BIG-IV, now available commercially as BabyBIG. High diagnostic acumen is needed for BIG-IV to be used early in the course of illness. In the randomized trial, IB was suspected upon admission in only half of the cases.

— Robert S. Baltimore, MD

Published in Journal Watch Infectious Diseases February 24, 2006

Citation(s):

Arnon SS et al. Human botulism immune globulin for the treatment of infant botulism. N Engl J Med 2006 Feb 2; 354:462-71.

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