Objective: To compare changes from baseline in upper limb spasticity (ULS) severity in different spastic patterns at 4 weeks and 12 weeks post-injection of incobotulinumtoxinA (incoA) versus placebo (PBO) in a large sample of elderly patients.

Background: Elderly patients are underrepresented in clinical trials due to inclusion and exclusion criteria. Data from clinical trials of botulinum toxin in ULS are therefore scarce in this patient population.

Method: Data from seven prospective, multicentre studies of incoA in the treatment of upper or upper and lower limb muscle spasticity in adults from across the world and with a range of ethnicities were pooled. In all studies, adult patients could receive incoA at a total body dose of 400 U. This analysis focuses on patients aged ≥65 years with ULS manifesting as a variety of spastic patterns; the least squares mean (LSM) change from baseline differences between incoA and PBO in Ashworth Scale (AS) score at 4- and 12-weeks post injection were calculated (one of the pooled studies used modified AS scores). “As observed” data were analyzed using ANCOVA. Safety was also evaluated throughout the 12-week period.

Results: Mean (SD) age of the 267 included patients was 70.3 (4.2) years; 15.0% were aged ≥75 years, 62.6% were male and mean (SD) time from spasticity diagnosis was 5.0 (5.4) years. The aetiology of spasticity was stroke in >99% of patients. For all ULS patterns with sufficient power for statistical analysis, incoA produced greater improvement in AS score compared with PBO at week 4 (p<0.05); for most of these patterns, the difference remained significant at week 12 (p<0.05) (Fig.1). IncoA was generally well tolerated, with no treatment-related serious adverse events or deaths reported (Table 1).

Conclusion: Results of this analysis in a large group of elderly patients from around the world show that incoA was well tolerated and upper limb muscle tone was improved. Therefore, ULS predominantly due to stroke was reduced.

Table 1.

Fig. 1

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MDS Abstracts - https://www.mdsabstracts.org/abstract/improvement-in-upper-limb-spasticity-patterns-in-the-elderly-following-treatment-with-incobotulinumtoxina-a-pooled-analysis/