Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications

Abstract

Botulinum neurotoxins (BoNTs) are proteins produced by bacteria of the Clostridium family. Upon oral ingestion, BoNT causes the neuroparalytic syndrome botulism. There are seven serotypes of BoNT (serotypes A-G); BoNT-A and BoNT-B are the botulinum toxin serotypes utilized for therapeutic applications. Treatment with BoNT injections is used to manage chronic medical conditions across multiple indications. As with other biologic drugs, immunogenicity after long-term treatment with BoNT formulations may occur, and repeated use can elicit antibody formation leading to clinical nonresponsiveness. Thus, approaching BoNT treatment of chronic conditions with therapeutic formulations that minimize stimulating the host immune response while balancing patient responsiveness to therapy is ideal. Immunogenicity is a clinical limitation in many settings

Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study

“…These findings are congruent with data on the immunogenicity of incobotulinumtoxinA treatment in the current literature and favorable for long-term treatment with incobotulinumtoxinA. These studies suggest that incobotulinumtoxinA treatment does not increase incidence of neutralizing antibodies in CD patients pretreated with other BoNT formulations [14] , [15] , [16] .…”

Immunogenicity Associated with Aesthetic Botulinumtoxin A: A Survey of Asia-Pacific Physicians’ Experiences and Recommendations

“…To date, no incidence of Xeomin-related STF due to nAb formation has been observed in treatment-naive patients. As a detailed exploration is beyond the scope of this article, we direct readers to a recent review, 32 which discusses immunogenicity due to BoNT/A formulations with or without accessory proteins, and the clinical and nonclinical evidence for this.…”

Behandlung der Sialorrhoe mit Botulinum Neurotoxin Typ A – Konsentierte Praxisempfehlungen für Kinder und Erwachsene

“…Tritt im Verlauf der Therapie eine Verringerung des Ansprechens auf die Behandlung auf, so sollte ein mögliches Fortschreiten der Grunderkrankung mit Verschlechterung der Sialorrhoe in Betracht gezogen werden. Ein sekundäres Therapieversagen als Folge neutralisierender Antikörper nach alleiniger Behandlung mit IncoBoNT/A wurde bisher nicht berichtet, ist aber nicht gänzlich auszuschließen 13 .…”