Human botulism immune globulin for the treatment of infant botulism.

Abstract

BACKGROUND:

We created the orphan drug Human Botulism Immune Globulin Intravenous (Human) (BIG-IV), which neutralizes botulinum toxin, and evaluated its safety and efficacy in treating infant botulism, the intestinal-toxemia form of human botulism.

METHODS:

We performed a five-year, randomized, double-blind, placebo-controlled trial statewide, in California, of BIG-IV in 122 infants with suspected (and subsequently laboratory-confirmed) infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin); treatment was given within three days after hospital admission. We subsequently performed a 6-year nationwide, open-label study of 382 laboratory-confirmed cases of infant botulism treated within 18 days after hospital admission.

RESULTS:

As compared with the control group in the randomized trial, infants treated with BIG-IV had a reduction in the mean length of the hospital stay, the primary efficacy outcome measure, from 5.7 weeks to 2.6 weeks (P<0.001). BIG-IV treatment also reduced the mean duration of intensive care by 3.2 weeks (P<0.001), the mean duration of mechanical ventilation by 2.6 weeks (P=0.01), the mean duration of tube or intravenous feeding by 6.4 weeks (P<0.001), and the mean hospital charges per patient by 88,600 dollars (in 2004 U.S. dollars; P<0.001). There were no serious adverse events attributable to BIG-IV. In the open-label study, infants treated with BIG-IV within seven days of admission had a mean length of hospital stay of 2.2 weeks, and early treatment with BIG-IV shortened the mean length of stay significantly more than did later treatment.

CONCLUSIONS:

Prompt treatment of infant botulism type A or type B with BIG-IV was safe and effective in shortening the length and cost of the hospital stay and the severity of illness.

• Authors: Stephen S Arnon, Robert Schechter, Susan E Maslanka, Nicholas P Jewell, Charles L Hatheway
• Journal: The New England journal of medicine (N Engl J Med) Vol. 354 Issue 5 Pg. 462-71 (Feb 02 2006) ISSN: 1533-4406 [Electronic] United States
• PMID: 16452558 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
• Copyright: Copyright 2006 Massachusetts Medical Society.

Chemical References

• Immunoglobulins
• Immunoglobulins, Intravenous
• botulism immune globulin
• rimabotulinumtoxinB
• Botulinum Toxins
• Botulinum Toxins, Type A

Topics

• Botulinum Toxins (immunology)
• Botulinum Toxins, Type A (immunology)
• Botulism (drug therapy)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Immunoglobulins (adverse effects, therapeutic use)
• Immunoglobulins, Intravenous (adverse effects, therapeutic use)
• Infant
• Infant, Newborn
• Length of Stay
• Male
• Treatment Outcome