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Efficacy of Human Botulism Immune Globulin for the Treatment of Infant Botulism: The First 12 Years Post Licensure
- Source :
- The Journal of Pediatrics. 193:172-177
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- Objectives To report the efficacy of Human Botulism Immune Globulin Intravenous (BIG-IV) in the first 12 years following its licensure in 2003 and to characterize its use nationwide in treating patients with infant botulism. Study design Medical records and billing information were collected for US patients treated with BIG-IV from 2003 to 2015. Length of hospital stay (LOS) and hospital charge information for treated patients were compared with the BIG-IV Pivotal Clinical Trial Placebo Group to quantify decreases in LOS and hospital charges. Results The use of BIG-IV reduced mean LOS from 5.7 to 2.2 weeks. This shortened hospital stay resulted in a mean decrease in hospital charges of $88 900 per patient. For all US patients 2003-2015, total decreases in LOS and hospital charges were 66.9 years and $86.2 million, respectively. The decrease in mean LOS was time dependent: BIG-IV treatment on hospital days 0-3 reduced mean LOS by 3.7 weeks ( P P P = NS). Since licensure, 1192 patients in 48 states and Washington, DC, have been treated with BIG-IV. Conclusions The use of BIG-IV since its licensure in 2003 treated approximately 93% of US patients with laboratory-confirmed infant botulism, and prevented >65 years in hospital stay and >$85 million in hospital charges from occurring. The greatest LOS reduction was achieved when BIG-IV was administered soon after hospital admission. Effective and appropriate use of BIG-IV in the US has continued in the postlicensure period.
- Subjects :
- Post licensure
Pediatrics
medicine.medical_specialty
Cost effectiveness
business.industry
Infant Botulism
Medical record
medicine.disease
Placebo group
Clinical trial
03 medical and health sciences
0302 clinical medicine
030225 pediatrics
Pediatrics, Perinatology and Child Health
Medicine
Botulism
Botulism immune globulin
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 00223476
- Volume :
- 193
- Database :
- OpenAIRE
- Journal :
- The Journal of Pediatrics
- Accession number :
- edsair.doi...........4f175d5abc6ad709baa51ba516622a0f