Sustained efficacy of incobotulinumtoxina repeated injections for upper-limb post-stroke spasticity: A post hoc analysis.
Petr Kaňovský, Elie P Elovic, Michael C Munin and 5 others
PMID 33112408WHAT IT FOUND
Repeated incobotulinumtoxinA injections for upper-limb post-stroke spasticity reduced muscle tone and caregiver burden more than placebo.
Benefits in tone and disability increased with each injection cycle up to 48 weeks, suggesting a cumulative effect rather than a single-shot fix.
Key findings
01IncobotulinumtoxinA significantly reduced muscle tone (AS arm sumscore) compared to placebo at 4, 8, and 12 weeks, with improvements continuing to increase across three open-label extension cycles.
02The responder rate for functional disability (DAS) increased from 47.4% in the main period to 66.6% during the third open-label extension cycle, indicating cumulative benefit.
03Caregiver burden significantly improved with repeated injections, with sustained reductions in the mean Carer Burden Scale score through the third open-label extension cycle.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
This is a post hoc analysis, not a pre-registered trial, which limits the certainty of the findings. The AS arm sumscore is a novel, unvalidated approach for assessing whole-arm spasticity. The modified Carer Burden Scale includes an unvalidated item ('applying a splint') added based on expert advice. The open-label extension period had no control group, so improvements in the OLEX phase cannot be definitively attributed to the drug versus natural history or other factors.
Declared interests
The study protocols were reviewed by ethics committees. Funding and conflicts of interest declarations are not explicitly detailed in the provided text snippets, but the study is sponsored by Merz Pharmaceuticals (implied by incobotulinumtoxinA brand and typical industry trial structures, though strictly adhering to text, no specific conflict statement is visible in the provided sentences other than general trial conduct).
The easy way to misread this
Do not assume the benefits observed in the open-label extension phase are solely due to the drug's cumulative effect, as there was no control group during this period to account for natural recovery or placebo effects in the repeated injection phase.