TY - JOUR
T1 - IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE
T2 - Efficacy in Passive Function, Caregiver Burden, and Quality of Life
AU - Marciniak, Christina
AU - Munin, Michael C.
AU - Brashear, Allison
AU - Rubin, Bruce S.
AU - Patel, Atul T.
AU - Slawek, Jaroslaw
AU - Hanschmann, Angelika
AU - Hiersemenzel, Reinhard
AU - Elovic, Elie P.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Background: Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden. Objective: To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300). Design: Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study. Setting: Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, United States). Participants: Adults, aged 18-80 years, ≥12 months since last botulinum neurotoxin injection or entirely toxin naïve, with median poststroke upper-limb spasticity of >2 years' duration. Methods: Participants who completed the 12-week, double-blind main period could enter the open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb. Main Outcome Measures: Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol [EQ] 5-dimensions three-level [EQ-5D-3L]). Results: The open-label extension included 296 treated patients. Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P <.0001). Carer Burden Scale scores also significantly improved from the main period baseline to the end-of-study visit (P <.05 for all caregiving activities except “applying a splint”). At the end-of-study visit, versus the main period baseline, 19.7%-33.3% of patients experienced improvements for each parameter on the EQ-5D-3L, except “mobility,” with significant improvement in EQ-5D visual analog scale scores (P <.001). Conclusions: Repeated incobotulinumtoxinA treatments at 12-week intervals in participants with chronic poststroke upper-limb spasticity resulted in significant improvements in QoL, as well as significant reductions in upper-limb functional disability and caregiver burden.
AB - Background: Poststroke spasticity affects motor function and the ability to perform activities of daily living, with the potential to affect quality of life (QoL) and increase caregiver burden. Objective: To investigate the effect of repeated incobotulinumtoxinA treatment on spasticity-associated functional disability, caregiver burden, and QoL in the 36-week open-label extension of the phase 3 PURE study (NCT01392300). Design: Open-label extension period of a prospective, double-blind, placebo-controlled, randomized, multicenter study. Setting: Forty-six investigation sites in seven countries (Czech Republic, Germany, Hungary, India, Poland, Russia, United States). Participants: Adults, aged 18-80 years, ≥12 months since last botulinum neurotoxin injection or entirely toxin naïve, with median poststroke upper-limb spasticity of >2 years' duration. Methods: Participants who completed the 12-week, double-blind main period could enter the open-label extension and receive up to three additional incobotulinumtoxinA treatments (fixed total dose 400 U at 12-week intervals) into the affected muscles of one upper limb. Main Outcome Measures: Functional disability (Disability Assessment Scale; DAS), caregiver burden (Carer Burden Scale), and quality of life (QoL; EuroQol [EQ] 5-dimensions three-level [EQ-5D-3L]). Results: The open-label extension included 296 treated patients. Mean DAS score for the principal target domain improved significantly from the main period baseline to the end-of-study visit (P <.0001). Carer Burden Scale scores also significantly improved from the main period baseline to the end-of-study visit (P <.05 for all caregiving activities except “applying a splint”). At the end-of-study visit, versus the main period baseline, 19.7%-33.3% of patients experienced improvements for each parameter on the EQ-5D-3L, except “mobility,” with significant improvement in EQ-5D visual analog scale scores (P <.001). Conclusions: Repeated incobotulinumtoxinA treatments at 12-week intervals in participants with chronic poststroke upper-limb spasticity resulted in significant improvements in QoL, as well as significant reductions in upper-limb functional disability and caregiver burden.
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U2 - 10.1002/pmrj.12265
DO - 10.1002/pmrj.12265
M3 - Article
C2 - 31647185
AN - SCOPUS:85078771156
JO - PM and R
JF - PM and R
SN - 1934-1482
ER -