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Post hoc analysis of the improvement in shoulder spasticity and safety observed following treatment with incobotulinumtoxinA.
J Rehabil Med. 2020 Mar 18; 52(3):jrm00028.JR

Abstract

OBJECTIVE

The Titration study in lOWer and uppER-limb spasticity (TOWER) study (NCT01603459), evaluated incobotulinumtoxinA for upper- and lower-limb spasticity. This post hoc analysis assessed shoulder spasticity in patients who received injections into the shoulder.

METHODS

Subjects received 3 injection cycles with escalating incobotulinumtoxinA doses on the same side (400, 600, 600-800 U; ≤ 600 U per limb including optional shoulder dose, planned range 100-250 U). Joint function was assessed with the Ashworth Scale shoulder sumscore (AS-SSS) in subjects treated in the shoulder vs those who were not. Safety was assessed in subjects treated in the shoulder, and in those who had upper-limb treatment without shoulder treatment.

RESULTS

The proportion of subjects receiving shoulder treatment increased with escalating dose at each cycle (n = 84/140 (60.0%) by cycle 3; mean (standard deviation (SD)) shoulder dose 118.4 U (SD 60.2)). From baseline to 4-weeks post-injection, mean AS-SSS improved by -1.1 (SD 1.9), -1.7 (SD 1.8) and -1.7 (1.8) in cycles 1, 2 and 3, respectively, in subjects treated in the shoulder, and -0.5 (SD 1.3), -0.8 (SD 1.6) and -0.9 (SD 1.4) in subjects who were not. A significant dose effect on AS-SSS was observed in cycle 3 (p = 0.0081). No unexpected safety concerns were reported.

CONCLUSION

The results demonstrate an improvement in shoulder spasticity and safety following incobotulinumtoxinA treatment.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

32025741

Citation

Wissel, Jörg, et al. "Post Hoc Analysis of the Improvement in Shoulder Spasticity and Safety Observed Following Treatment With IncobotulinumtoxinA." Journal of Rehabilitation Medicine, vol. 52, no. 3, 2020, pp. jrm00028.
Wissel J, Bensmail D, Scheschonka A, et al. Post hoc analysis of the improvement in shoulder spasticity and safety observed following treatment with incobotulinumtoxinA. J Rehabil Med. 2020;52(3):jrm00028.
Wissel, J., Bensmail, D., Scheschonka, A., Flatau-Baqué, B., Simon, O., Althaus, M., & Simpson, D. M. (2020). Post hoc analysis of the improvement in shoulder spasticity and safety observed following treatment with incobotulinumtoxinA. Journal of Rehabilitation Medicine, 52(3), jrm00028. https://doi.org/10.2340/16501977-2651
Wissel J, et al. Post Hoc Analysis of the Improvement in Shoulder Spasticity and Safety Observed Following Treatment With IncobotulinumtoxinA. J Rehabil Med. 2020 Mar 18;52(3):jrm00028. PubMed PMID: 32025741.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post hoc analysis of the improvement in shoulder spasticity and safety observed following treatment with incobotulinumtoxinA. AU - Wissel,Jörg, AU - Bensmail,Djamel, AU - Scheschonka,Astrid, AU - Flatau-Baqué,Birgit, AU - Simon,Olivier, AU - Althaus,Michael, AU - Simpson,David M, PY - 2020/2/7/pubmed PY - 2020/2/7/medline PY - 2020/2/7/entrez KW - botulinum neurotoxin type A KW - incobotulinumtoxinA KW - shoulder spasticity KW - stroke KW - upper-limb, lower-limb SP - jrm00028 EP - jrm00028 JF - Journal of rehabilitation medicine JO - J Rehabil Med VL - 52 IS - 3 N2 - OBJECTIVE: The Titration study in lOWer and uppER-limb spasticity (TOWER) study (NCT01603459), evaluated incobotulinumtoxinA for upper- and lower-limb spasticity. This post hoc analysis assessed shoulder spasticity in patients who received injections into the shoulder. METHODS: Subjects received 3 injection cycles with escalating incobotulinumtoxinA doses on the same side (400, 600, 600-800 U; ≤ 600 U per limb including optional shoulder dose, planned range 100-250 U). Joint function was assessed with the Ashworth Scale shoulder sumscore (AS-SSS) in subjects treated in the shoulder vs those who were not. Safety was assessed in subjects treated in the shoulder, and in those who had upper-limb treatment without shoulder treatment. RESULTS: The proportion of subjects receiving shoulder treatment increased with escalating dose at each cycle (n = 84/140 (60.0%) by cycle 3; mean (standard deviation (SD)) shoulder dose 118.4 U (SD 60.2)). From baseline to 4-weeks post-injection, mean AS-SSS improved by -1.1 (SD 1.9), -1.7 (SD 1.8) and -1.7 (1.8) in cycles 1, 2 and 3, respectively, in subjects treated in the shoulder, and -0.5 (SD 1.3), -0.8 (SD 1.6) and -0.9 (SD 1.4) in subjects who were not. A significant dose effect on AS-SSS was observed in cycle 3 (p = 0.0081). No unexpected safety concerns were reported. CONCLUSION: The results demonstrate an improvement in shoulder spasticity and safety following incobotulinumtoxinA treatment. SN - 1651-2081 UR - https://www.unboundmedicine.com/medline/citation/32025741/Post_hoc_analysis_of_shoulder_spasticity_and_safety_following_treatment_with_incobotulinumtoxinA L2 - https://www.medicaljournals.se/jrm/content/abstract/10.2340/16501977-2651 DB - PRIME DP - Unbound Medicine ER -
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