Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA

Klemens Fheodoroff, Tiina Rekand, Luisa Medeiros, Peter Koßmehl, Jörg Wissel, Djamel Bensmail, Astrid Scheschonka, Birgit Flatau-Baqué, Olivier Simon, Dirk Dressler, David M Simpson, Klemens Fheodoroff, Tiina Rekand, Luisa Medeiros, Peter Koßmehl, Jörg Wissel, Djamel Bensmail, Astrid Scheschonka, Birgit Flatau-Baqué, Olivier Simon, Dirk Dressler, David M Simpson

Abstract

Background: We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study.

Methods: In this exploratory trial, subjects (N = 155; 18-80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks' follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3.

Results: The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with 'improvement' was greater than that with 'worsening' for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as 'normal' increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of 'severe impairment'.

Conclusion: These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies.

Trial registration: ClinicalTrials.gov, NCT01603459. Date of registration: May 22, 2012.

Keywords: Botulinum neurotoxin; IncobotulinumtoxinA; Long-term care; Lower limb; Quality of life; Spasticity; Spasticity management; Upper limb.

Conflict of interest statement

KF has received research grants from Ipsen and Merz Pharmaceuticals, and has received sponsorship from Allergan, Ipsen, and Merz Pharmaceuticals to attend conferences and advisory board meetings in the EU. TR has served as a consultant for Allergan, Ipsen, Medtronic, and Merz Pharmaceuticals. LM has received research grants from Merz Pharmaceuticals. PK has received research grants from Ipsen, Medtronic, and Merz Pharmaceuticals, and has received sponsorship from Ipsen, Medtronic, and Merz Pharmaceuticals to attend conferences and/or advisory board meetings in the EU. JW has received research grant support from, and served as a consultant for, Allergan, Ipsen, Medtronic, and Merz Pharmaceuticals. DB has served as a consultant for Allergan, Almirall, Ipsen, Medtronic, and Merz Pharmaceuticals. AS and BF-B are employees of Merz Pharmaceuticals. OS is a former employee of Merz Pharmaceuticals. DD has received payments from AbbVie, Allergan, Bayer, IAB-Interdisciplinary Working Group for Movement Disorders, Ipsen, Medtronic, Merz Pharmaceuticals, Sintetica, Syntaxin, and UCB, and is a shareholder of Allergan. DD also holds patents on botulinum toxin and botulinum toxin therapy. DMS has received research grant support from, and served as a consultant for, Allergan, Ipsen, and Merz Pharmaceuticals.

Figures

Fig. 1
Fig. 1
a Mean (SD), and b mean (95% CI) change in EQ-5D VAS scores (FAS). a) Time points: at injection cycle baseline and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. b) Time points: from the study baseline to 4 weeks post-injection in each injection cycle and to the end of injection cycle 3. Positive values indicate improvement. *p < 0.0001 compared with the study baseline visit in injection cycle 1, Student’s t-test for paired samples. CI, confidence interval; EQ-5D, EuroQol 5-dimensions questionnaire, three-level; FAS, full analysis set; SD, standard deviation; VAS, visual analog scale
Fig. 2
Fig. 2
Subjects with improvement or worsening of EQ-5D ratings in all dimensions (FAS). Time points: from study baseline to the end of injection cycle 3 (N = 138). EQ-5D, EuroQol 5-dimensions questionnaire, three-level; FAS, full analysis set; n, number of observed cases
Fig. 3
Fig. 3
‘Severe impairment’ of QoL at study baseline and end of cycle 3 (FAS). EQ-5D, EuroQol 5-dimensions questionnaire, three-level; FAS, full analysis set; n, number of observed cases; QoL, quality of life

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