High response rate as early as 4 weeks after incobotulinumtoxinA injection for upper limb spasticity
Presenter: Franco Molteni, MD, Valduce Villa Beretta Hospital, Costa Masnaga, Italy
Improvement in spasticity-associated dressing- and hygiene-related disability in adults following treatment with incobotulinumtoxinA: a pooled analysis. Abstract 946. Presented August 29, 2023.
A pooled analysis of phase 2 and phase 3 clinical trials shows that incobotulinumtoxinA, an acetylcholine release inhibitor and neuromuscular blocker, is significantly more effective than placebo in improving both dressing-related disability (DRE) and hygiene-related disability (HYG) at 4 weeks postinjection in adults with upper limb spasticity. The effects were enhanced over multiple injection cycles, showing a sustained effect.
Response rates 4 weeks after the first cycle were significantly higher for incobotulinumtoxinA versus placebo for both DRE (32.2% vs 18.6%; P < 0.0001) and HYG (33.0% vs 19.2%; P < 0.0001). Odds ratios for response favoring incobotulinumtoxinA over placebo were 2.03 for DRE (P < 0.0013) and 2.73 for HYG (P < 0.0001). Response rates 4 weeks after the first injection were significantly higher for incobotulinumtoxinA than placebo regardless of DRE baseline severity (P < 0.05 for all severity groups) and in patients with moderate or severe HYG at baseline (P < 0.05)
“These results support the use of incobotulinumtoxinA to sustainably improve DRE and HYG,” according to Franco Molteni, MD, Valduce Villa Beretta Hospital, Costa Masnaga, Italy, and colleagues.
Upper limb spasticity, a symptom of many central nervous system disorders, influences coordinated movements, limiting joint functioning and predisposing those affected to complications such as joint contractures and pain. “Spasticity-associated dressing-related disability and hygiene-related disability are functional impairments that negatively impact quality of life in patients with upper limb spasticity,” they wrote in their poster presentation.
The analysis included 937 participants from four double-blind, placebo-controlled trials. Of those, 716 received incobotulinumtoxinA and 221 received a placebo. Mean age of patients was 55.9 years and 37.6% were women. Among the 907 patients (96.8% of the overall cohort) with DRE at baseline, the baseline Disability Assessment Scale (DAS) dressing score was considered mild in 141 (15.6%), moderate in 508 (56.0%), and severe in 258 (28.5%). Of the 865 with HYG at baseline, the baseline DAS hygiene score was mild in 165 (19.1%), moderate in 462 (53.4%), and severe in 238 (27.5%).
Of the 937 patients, 918 (98.0%) had upper limb position abnormality at baseline, according to the DAS Limb Position Score. Their disease severity was ranked as mild (10.5%), moderate (51.0%), and severe (38.6%). Baseline characteristics were numerically similar between the incobotulinumtoxinA and placebo recipients who had upper limb position abnormality, DRE, and an HYG score of at least 1 at baseline.
The response rates on the DAS dressing domain increased progressively over incobotulinumtoxinA treatment cycles, reaching a maximum of 49.2% at 4 weeks after the fourth injection cycle. Response rates for HYG also increased at each injection cycle, to a maximum of 55.6% at 4 weeks after the fourth injection cycle.
Disclosure
Franco Maletni has received unrestricted grants from Allergan and Merz Therapeutics.