Objective: To compare upper limb spasticity (ULS) severity changes from baseline in different spastic patterns at 4 weeks and 12 weeks post-injection of incobotulinumtoxinA (incoA) versus placebo (PBO) in elderly patients with moderate-to-severe ULS using pooled data from six clinical trials.

Background: There is underrepresentation of elderly patients in clinical trials due to inclusion and exclusion criteria. Clinical data on botulinum toxin and ULS in this patient population are therefore scarce.

Method: Pooled data were extracted from six prospective, multicentre studies of incoA in the treatment of upper or upper and lower limb muscle spasticity in adults from across the world and of a range of ethnicities. In all studies, adult patients could receive incoA most commonly at a total body dose of 400 U. This analysis focuses on a subgroup of patients aged ≥65 years with moderate-to-severe ULS at baseline manifesting as a variety of spastic patterns. Severity was determined by AS; moderate = not severe and AS ≥3 in at least 2 joints assessed; severe: AS = 4 in at least 2 joints assessed. Least squares mean (LSM) change from baseline differences between incoA and PBO in Ashworth Scale (AS) score of different spasticity patterns, at 4- and 12-weeks post injection were calculated (one of the pooled studies used modified AS scores). “As observed” data were analysed using ANCOVA. Safety was also evaluated throughout the 12-week period.

Results: Mean (SD) age of the 207 included patients was 70.0 (4.1) years; 13.5% were aged ≥75 years, 63.3% were male, mean (SD) time from spasticity diagnosis was 5.3 (5.3) years and 85.5% had moderate and 14.5% had severe ULS. 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 (Table 1), with few differences reported between patients aged 65 to <75 years and ≥75 years.

Conclusion: In this subgroup analysis of elderly patients with moderate-to-severe ULS, incoA was well tolerated and improved upper limb muscle tone, thereby reducing debilitating ULS that was predominantly due to stroke.

Table 1

Fig.1

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