Abstract
BackgroundAmong the spectrum of licensed botulinum neurotoxin preparations incobotulinumtoxin (incoBoNT/A; Xeomin®) is the only one which does not contain complex proteins. Therefore, incoBoNT/A has been suggested to have a low antigenicity, but precise estimations on incidence and prevalence of neutralizing antibody formation during long-term treatment are outstanding so far.MethodsFor the present cross-sectional study, 59 patients having exclusively been treated with incoBoNT/A (mono group) and 32 patients having been treated with other BoNT/A preparations less than nine times and who were then switched to at least 14 sessions of incoBoNT/A treatment (switch group) were recruited from one botulinum toxin outpatient clinic. Side effects and doses were extracted from the charts, and the efficacy of treatment was assessed by the patients using a visual analogue scale (0–100). The prevalence of neutralizing antibodies was tested by means of the mouse hemi-diaphragm assay (MHDA).FindingsNone of the patients in the mono and only two in the switch group had a positive MHDA-test. Across all indications and patients, mean improvement exceeded 67%. Improvement did not depend on age at onset, sex, change of dose or duration of treatment, but on disease entity. In patients with cervical dystonia, improvement was about the same in the mono and switch subgroup, but the last dose was different.ConclusionsThe present study confirms the low antigenicity of incoBoNT/A, which has immediate consequences for patient management, and the use of higher doses and shorter durations of reinjection intervals in botulinum toxin therapy.
Highlights
The popularity of botulinum neurotoxin (BoNT) applications is continuously growing among clinicians and the general public [1]
This study aims to determine the incidence and prevalence of neutralizing antibody (NAB) formation under incoBoNT/A long-term treatment as well as a confounding effect of preceding injections with a complex protein-containing preparation
In agreement with Aoki and Guyer [21], we conclude that: “Due to the association between neurotoxin protein load and neutralizing antibody formation, the optimal strategy would be to minimize the risk of developing neutralizing antibodies. This can be accomplished by treating patients with a neurotoxin preparation that contains the lowest possible amount of neurotoxin protein per effective dose” [21]. This is the first study on NAB formation and clinical effect in a larger cohort of patients who had unsatisfactorily been pre-treated with ona- and/or aboBoNT/A, but were switched to Botulinum neurotoxin type A (BoNT/A)
Summary
The popularity of botulinum neurotoxin (BoNT) applications is continuously growing among clinicians and the general public [1]. Repetitive injections of botulinum neurotoxin have to be performed [4] to maintain a certain level of improvement. Since these repetitive injections are applied transdermally, activation of dentritic cells can hardly be avoided [5] with the risk of neutralizing antibody (NAB) formation. Conclusions The present study confirms the low antigenicity of incoBoNT/A, which has immediate consequences for patient management, and the use of higher doses and shorter durations of reinjection intervals in botulinum toxin therapy
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