Botulinum toxin treatment of spasticity targeted to muscle endplates: an international, randomised, evaluator-blinded study comparing two different botulinum toxin injection strategies for the treatment of upper limb spasticity. Issue 5 (5th May 2019)

• Record Type: Journal Article
• Authors: Rekand, Tiina; Biering-Sörensen, Bo; He, Jun; Vilholm, Ole Jakob; Christensen, Peter Brøgger; Ulfarsson, Trandur; Belusa, Roger; Ström, Torbjörn; Myrenfors, Peter; Maisonobe, Pascal; Dalager, Torben
• Other Names: Rekand Tiina author non-byline.; Biering-sörensen Bo author non-byline.; He Jun author non-byline.; Vilholm Ole Jakob author non-byline.; Christensen Peter Brøgger author non-byline.; Ulfarsson Trandur author non-byline.; Belusa Roger author non-byline.; Ström Torbjörn author non-byline.; Myrenfors Peter author non-byline.; Maisonobe Pascal author non-byline.; Dalager Torben author non-byline.; Gyllenborg Jesper author non-byline.; Ylinen Jari author non-byline.; Saukkonen Anna-maija author non-byline.; Berg Ottar author non-byline.; Kullander Kjell author non-byline.; Axelsson Ann author non-byline.; Öhman Eilert author non-byline.; Siberna-grajnert Magdalena author non-byline.; Morell-larsen Miriam author non-byline.; Bäckström Inge author non-byline.
• Is Part Of: BMJ open. Volume 9:Issue 5(2019)
• Publication Date: 2019-05-05
• Subjects: botulinum toxin -- abobotulinumtoxina -- bont -- neuromuscular junctions -- nmj zone; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-024340
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objectives: The therapeutic effects of botulinum neurotoxin (BoNT) are well documented in upper limb spasticity. However, several factors may influence treatment efficacy, including targeting of neuromuscular junctions (NMJs). We examined whether NMJ-targeted BoNT injections were non-inferior, in terms of efficacy, to current injection practices. Design: Open-label prospective evaluator-blinded study. Setting: Conducted across 20 medical centres in Denmark, Finland, Norway and Sweden (24 September 2012 to 11 March 2015). Participants: Aged ˃18 years with upper limb spasticity (Modified Ashworth Scale [MAS] score of 2 or 3) following stroke or traumatic brain injury, had received ≥2 consecutive BoNT-A treatment cycles (the latest of which was abobotulinumtoxinA [aboBoNT-A]) and needed BoNT-A retreatment (same modality as previous cycle). Patients requiring aboBoNT-A doses >800units were excluded. In total, 88 patients were randomised (intention-to-treat [ITT] population), most were male (n=58/88, 65.9%) and 54/88 (61.4%) completed the study (per protocol [PP] population). Interventions: Randomisation (1:1) to receive a single dose of aboBoNT-A (≤800 U) according to either current clinical practice (300 U/mL) or as an NMJ-targeted injection (100 U/mL). Primary outcome measure: Proportion of patients with a ≥1 level reduction from baseline in MAS score at week 4 post-injection (responders). Results: In the ITT population, the proportion of responders at elbow flexors was 72.7% in the current practice group and 56.8% in the NMJ-targeted group (adjusted difference −0.1673 [95% CIs: −0.3630 to 0.0284]; p=0.0986). Similar results were observed in the PP population (69.0% vs 68.0%, respectively, adjusted difference 0.0707 [−0.1948 to 0.3362]; p=0.6052). Conclusions: Owing to the limited number of participants, non-inferiority of NMJ-targeted injections could not be determined. However, there was no statistical difference between groups. Larger studies are needed confirm whether the two techniques offer comparable efficacy. Trial registration number: NCT01682148 .