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Botulinum toxin type A products are not interchangeable: a review of the evidence.

Brin MF, James C, Maltman J - Biologics (2014)

Bottom Line: These differences result in a specific set of interactions between each BoNTA product and the tissue injected.Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events.Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication.

View Article: PubMed Central - PubMed

Affiliation: Allergan, Inc., Irvine, CA, USA ; Department of Neurology, University of California, Irvine, CA, USA.

ABSTRACT
Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.

No MeSH data available.


Comparison of clinical response of two hypothetical BoNTA products.Notes: (A) Graph showing hypothetical response at months 1 and 4 for two different products. Assessed at only month 1 and 4, the products may appear equivalent. (B) Graph showing hypothetical response at months 1, 2, 3, and 4 for the same two products. The products clearly exhibit different pharmacodynamics, as evidenced at months 2 and 3.
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f1-btt-8-227: Comparison of clinical response of two hypothetical BoNTA products.Notes: (A) Graph showing hypothetical response at months 1 and 4 for two different products. Assessed at only month 1 and 4, the products may appear equivalent. (B) Graph showing hypothetical response at months 1, 2, 3, and 4 for the same two products. The products clearly exhibit different pharmacodynamics, as evidenced at months 2 and 3.

Mentions: A lack of significant difference in efficacy at single or limited time points cannot be equated to interchangeability; the products may show differences at other points along the efficacy dose–response curves, as well as differences in dose-dependent adverse events (Figure 1). Moreover, results obtained under a given set of conditions for a given indication cannot be assumed to apply to other indications where different muscles, glands, or organs may be injected; this may be attributable to product-specific tissue interactions.


Botulinum toxin type A products are not interchangeable: a review of the evidence.

Brin MF, James C, Maltman J - Biologics (2014)

Comparison of clinical response of two hypothetical BoNTA products.Notes: (A) Graph showing hypothetical response at months 1 and 4 for two different products. Assessed at only month 1 and 4, the products may appear equivalent. (B) Graph showing hypothetical response at months 1, 2, 3, and 4 for the same two products. The products clearly exhibit different pharmacodynamics, as evidenced at months 2 and 3.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4199839&req=5

f1-btt-8-227: Comparison of clinical response of two hypothetical BoNTA products.Notes: (A) Graph showing hypothetical response at months 1 and 4 for two different products. Assessed at only month 1 and 4, the products may appear equivalent. (B) Graph showing hypothetical response at months 1, 2, 3, and 4 for the same two products. The products clearly exhibit different pharmacodynamics, as evidenced at months 2 and 3.
Mentions: A lack of significant difference in efficacy at single or limited time points cannot be equated to interchangeability; the products may show differences at other points along the efficacy dose–response curves, as well as differences in dose-dependent adverse events (Figure 1). Moreover, results obtained under a given set of conditions for a given indication cannot be assumed to apply to other indications where different muscles, glands, or organs may be injected; this may be attributable to product-specific tissue interactions.

Bottom Line: These differences result in a specific set of interactions between each BoNTA product and the tissue injected.Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events.Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication.

View Article: PubMed Central - PubMed

Affiliation: Allergan, Inc., Irvine, CA, USA ; Department of Neurology, University of California, Irvine, CA, USA.

ABSTRACT
Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.

No MeSH data available.