Efficacy and Safety of Botulinum Toxin Type A (NABOTA) for Post-stroke Upper Extremity Spasticity: A Multicenter Phase IV Trial
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Objective To evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea.Methods This prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12.Results There was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial.Conclusion NABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.
Abstract
Objective To evaluate the efficacy and safety of Daewoong botulinum toxin type A (NABOTA) after its launch in South Korea.Methods This prospective, multicenter, open-label phase IV clinical trial included 222 patients with stroke. All patients visited the clinic at baseline and at weeks 4, 8, and 12 after injection of upto 360 units of NABOTA into the wrist, elbow, and finger flexor muscles at the first visit. The primary outcome was the change in Modified Ashworth Scale (MAS) score for the wrist flexor muscles between baseline and week 4. The secondary outcomes were the changes in MAS, Disability Assessment Scale (DAS), and Caregiver Burden Scale (CBS) scores between baseline and each visit, and the Global Assessment Scale (GAS) score at week 12.Results There was a statistically significant decrease in the MAS score for the wrist flexors between baseline and week 4 (-0.97±0.66, p<0.001). Compared with baseline, the MAS, DAS and CBS scores improved significantly during the study period. The GAS was rated as very good or good by 86.8% of physicians and by 60.0% of patients (or caregivers). The incidence of adverse events was 14.4%, which is smaller than that in a previous trial.Conclusion NABOTA showed considerable efficacy and safety in the management of upper limb spasticity in stroke patients.
참고문헌 (19)
- Se Hee Jung, "Stroke Rehabilitation Fact Sheet in Korea", Annals of Rehabilitation Medicine, 46(1), pp.1~8 (2022), 대한재활의학회
- Kuo CL, "Post-stroke spasticity : a review of epidemiology, pathophysiology, and treatments", Int J Gerontol, 12, pp.280~284 (2018)
- Sunnerhagen KS, "Assessing and treating functional impairment in poststroke spasticity", Neurology, 80(3 Suppl 2), pp.S35~S44 (2013)
- Kim CS, "Method for production of botulinum toxin. World patent WO 2015", 016462 (KR2014, pp.2015, ~
- Kim CS, "Electrophysiological study for comparing the effect of biological activity between type A botulinum toxins in rat gastrocnemius muscle", Hum Exp Toxicol, 32, pp.914~920 (2013)
- Nam HS, "Efficacy and safety of NABOTA in post-stroke upper limb spasticity : a phase 3 multicenter, doubleblinded, randomized controlled trial", J Neurol Sci, 357, pp.192~197 (2015)
- Bohannon RW, "Interrater reliability of a modified Ashworth scale of muscle spasticity", Phys Ther, 67, pp.206~207 (1987)
- Brashear A, "Inter-and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity", Arch Phys Med Rehabil, 83, pp.1349~1354 (2002)
- Elmstahl S, "Caregiver’s burden of patients 3 years after stroke assessed by a novel caregiver burden scale", Arch Phys Med Rehabil, 77, pp.177~182 (1996)
- Bhakta BB, "Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke : a randomised double blind placebo controlled trial", J Neurol Neurosurg Psychiatry, 69, pp.217~221 (2000)
- Brashear A, "Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke", N Engl J Med, 347, pp.395~400 (2002)
- Seo HG, "Neuronox versus BOTOX in the treatment of post-stroke upper limb spasticity : a multicenter randomized controlled trial", PLoS One, 10, pp.e0128633~ (2015)
- "MEDITOXIN versus BOTOX in the treatment of post-stroke spasticity of the upper limb spasticity (ClinicalTrials.gov Identifier: NCT01313767)" (2011)[URL]
- Ney JP, "Neurologic uses of botulinum neurotoxin type A", Neuropsychiatr Dis Treat, 3, pp.785~798 (2007)
- Rousseaux M, "Efficacy of botulinum toxin A in upper limb function of hemiplegic patients", J Neurol, 249, pp.76~84 (2002)
- Shaw LC, "Botulinum Toxin for the Upper Limb after Stroke(BoTULS)Trial : effect on impairment, activity limitation, and pain", Stroke, 42, pp.1371~1379 (2011)
- Dunne JW, "Treatment of chronic limb spasticity with botulinum toxin A", J Neurol Neurosurg Psychiatry, 58, pp.232~235 (1995)
- Bergfeldt U, "Focal spasticity therapy with botulinum toxin : effects on function, activities of daily living and pain in 100 adult patients", J Rehabil Med, 38, pp.166~171 (2006)
- Cardoso E, "Botulinum toxin type A for the treatment of the upper limb spasticity after stroke : a metaanalysis", Arq Neuropsiquiatr, 63, pp.30~33 (2005)