Type A Botulinum Toxin–Induced Antibody Production: A Murine Model of Antibody Response
Accepted 16 June 2009.
Background
The use of modified botulinum toxin type A (BCB2024 BTA; Allergan, Irvine, CA) has burgeoned worldwide since 1998. However, the drug's potential to create an immunogenic response has remained unclear.
Objective
The authors report on a prospective murine model study to evaluate the potential immunogenic effect of BTA and to determine the effect of dose size and frequency of administration on antibody formation.
Methods
Forty female CD-1 mice were divided into four equal groups that received injections of BCB2024 BTA as follows: group A, 0.12 U every two months; group B, 0.12 U once a month; group C, 0.24 U every two months; and group D, 0.24 U once a month. Blood was collected before the first injection and then every month for four months. Immune response was determined by measuring the level of serum immunoglobulin G using enzyme-linked immunosorbent assay. Data were analyzed with a mixed-model, repeated measures analysis of variance.
Results
Nascent antibotox antibody (ABA) production in response to BCB2024 BTA administration was observed in all four subgroups. Levels of ABA were significantly higher in the higher-frequency dosage groups than in the lower-frequency groups. ABA levels were slightly lower in the low-dosage groups than in the higher-dosage groups, but the differences were not statistically significant.
Conclusions
Our study showed frequency-dependent production of ABA in response to BCB2024 BTA administration in a murine model. The clinical significance of such antibody production remains to be determined. Presently however, no standardized scale of conversion exists to relate murine doses of BTA to those used in human treatment regimens.
Reprint requests: Daniel David Sutphin, MD, University of Tennessee Medical Center, Department of Surgery, Division of Plastic Surgery, 1924 Alcoa Hwy., Box U-11, Knoxville, TN 37920
DISCLOSURES
The authors have no financial interest in and have received no compensation from manufacturers of any product mentioned in this article.
Presented at the 52nd Annual Scientific Meeting of the Southeastern Society of Plastic and Reconstructive Surgeons, Rio Grande, Puerto Rico, June 6–10, 2009.
1 The authors are from the University of Tennessee, Knoxville, TN. Drs. Sutphin and Chun are from the Division of Plastic Surgery, Department of Surgery, University of Tennessee Medical Center.
2 Dr. Hill is from the College of Veterinary Medicine.
3 Ms. Kirkpatrick, Dr. Mountain, and Ms. Packan are from the Vascular Research Lab, University of Tennessee Medical Center.
4 Mr. Muenchen is from the Statistical Consulting Center, University of Tennessee.
ABSTRACT