Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial.
Alberto Esquenazi, Gaëtan Stoquart, Peter Hedera and 8 others
PMID 32108436WHAT IT FOUND
With ongoing physiotherapy and stable concomitant medications, such as pain medication, anticholinergic drugs, and muscle relaxants, abobotulinumtoxinA 1000 U or 1500 U showed larger tone reductions than placebo.
These subgroup differences were not tested.
Key findings
01In previously treated patients who also continued physiotherapy and stable medications, mean change from baseline to week 4 in gastrocnemius-soleus complex MAS tone was -0.8 with abobotulinumtoxinA 1000 U, -0.9 with 1500 U, and -0.4 with placebo.
02More previously treated patients responded to abobotulinumtoxinA than placebo in the gastrocnemius-soleus complex, and the 1500 U group had a higher responder rate than the 1000 U group at each time point, while physiotherapy and concomitant medications were continued.
03The most common treatment-emergent adverse events were fall, muscular weakness, and pain in an extremity, with ongoing physiotherapy and stable concomitant medications.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
This is a post hoc subgroup analysis, and the study was not powered to detect statistical significance, so only descriptive statistics are provided. The analysis included 84 previously treated patients, and the efficacy population included 29, 28, and 26 patients in the abobotulinumtoxinA 1000 U, abobotulinumtoxinA 1500 U, and placebo groups. All patients continued community-based physiotherapy at the same frequency and intensity until week 4, or study end if possible, and concomitant medications were kept stable, so the contribution of any single component cannot be separated. Some secondary outcomes, including physician's global assessment and walking speed tests, were not reported in this analysis. Patients had to walk unaided at 0.1 to 0.8 m/s, so the results may not apply to patients with more severe gait impairment or dependence on walking aids. Time since the last previous botulinum toxin A injection ranged widely, from 113 to 1769 days in the 1000 U group, 123 to 2953 days in the 1500 U group, and 127 to 2359 days in the placebo group. Patients previously treated with abobotulinumtoxinA were excluded, so this does not address switching from abobotulinumtoxinA to another product or back. Only a single injection cycle was analyzed here, and the paper notes that some outcomes required multiple cycles to show meaningful results.
Declared interests
AbobotulinumtoxinA is marketed by Ipsen. The author disclosures state that authors received research funding, consultancy fees, grants, or investigator support from Ipsen and other botulinum toxin companies, that some authors are employed by Ipsen, and that another author is employed by a company subcontracted to Ipsen.
The easy way to misread this
Do not read the larger tone reductions as proof that abobotulinumtoxinA works after prior botulinum toxin treatment. This was a post hoc analysis of 84 patients without statistical testing, and patients also continued physiotherapy and stable medications, so the effect of the toxin alone cannot be separated.