Abstract
Under continuous long-term treatment with abo- or onabotulinum toxin type A (BoNT/A), ~10 to 15% of patients with cervical dystonia (CD) will develop neutralizing antibodies and reduced responsiveness over an ~10-year treatment period. Among the botulinum neurotoxin type A preparations so far licensed for CD, incobotulinum toxin A (incoBoNT/A; Xeomin®) is the only one without complex proteins. Whether CD patients with treatment failure under abo- or onaBoNT/A may still respond to incoBoNT/A is unknown. In this cross-sectional, retrospective study, 64 CD patients with secondary treatment failure after abo- or onaBoNT/A therapy who were switched to incoBoNT/A were compared to 34 CD patients exclusively treated with incoBoNT/A. The initial clinical severity of CD, best outcome during abo- or onaBoNT/A therapy, severity at the time of switching to incoBoNT/A and severity at recruitment, as well as all corresponding doses, were analyzed. Furthermore, the impact of neutralizing antibodies (NABs) on the long-term outcome of incoBoNT/A therapy was evaluated. Patients significantly improved after the switch to incoBoNT/A (p < 0.001) but did not reach the improvement level obtained before the development of partial secondary treatment failure or that of patients who were exclusively treated with incoBoNT/A. No difference between abo- and onaBoNT/A pretreatments or between the long-term outcomes of NAB-positive and NAB-negative patients was found. The present study demonstrates significant long-term improvement after a switch to incoBoNT/A in patients with preceding secondary treatment failure after abo- or onaBoNT/A therapy and confirms the low antigenicity of incoBoNT/A.
Highlights
As a first sign of neutralizing antibodies (NABs)-induced reduction of efficacy, the duration of efficacy will decrease [5]. This implies that, in case of NAB-induced secondary treatment failure (STF), the stable plateau cannot be maintained, and a secondary gradual worsening occurs [11,18]
A significant, long-lasting improvement was demonstrated in patients with partial secondary treatment failure (PSTF) after abo- or onaBoNT/A therapy when switched to incoBoNT/A
Switching to incoBoNT/A is a relevant alternative to deep brain stimulation (DBS) in patients with
Summary
Repetitive injections of botulinum neurotoxin type A (BoNT/A) are the treatment of choice for a variety of indications [1]. Because of the traumatic route of application by transdermal injections of BoNT/A, activation of dendritic and B- and T-cells [2,3] and induction of antibodies (ABs) can hardly be avoided during the treatment course [4]. The correlation between NAB titer and clinical outcome is usually weak [4], and the development of complete secondary treatment failure (CSTF) is rare [6,7]. Partial secondary treatment failure (PSTF) is frequent [8,9,10], may occur early [11] and increases with the dose per session and treatment duration [8,9]. An increase in the dose or a switch to rimabotulinumtoxin type B (rimaBoNT/B) may help for a few treatment cycles [12]
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