Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study

Rosales, Raymond L.; Balcaitiene, Jovita; Berard, Hugues; Maisonobe, Pascal; Goh, Khean Jin; Kumthornthip, Witsanu; Mazlan, Mazlina; Latif, Lydia Abdul; Santos, Mary Mildred Delgado-Delos; Chotiyarnwong, Chayaporn; Tanvijit, Phakamas; Nuez, Odessa; Kong, Keng He

doi:10.3390/toxins10070253

Cited by 39 publications

(49 citation statements)

References 36 publications

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“…Importantly, we observed continued effectiveness and safety with repeat treatments. Thus, as suggested by Rosales and colleagues (20), it follows that patients who receive early treatment will gain more time living with reduced spasticity than if they were treated later in their lifetime. In addition, the conditions for rehabilitation are typically better in the subacute vs. the chronic phase.…”

Section: Discussionmentioning

confidence: 90%

“…Finally, another important limitation is our quartile-based definition of early-start treatment, where the mean time since stroke was 3.2 months. This is just on the upper limits of the study-based definitions for "very early intervention" where botulinum toxin has been given within 2-12 weeks of the event to try and target neutrally mediated spasticity (18)(19)(20). Other factors having influenced the outcome might be the measurement not at peak effect, but rather at the end of the treatment effect and the shorter intervals and higher dose in the late compared to the early group.…”

Section: Discussionmentioning

confidence: 99%

“…AbobotulinumtoxinA is approved for the management of adult upper (and lower) limb spasticity. Recent randomized, placebocontrolled data indicate potential benefits of early treatment with abobotulinumtoxinA in terms of delaying development of hypertonicity, reducing pain and passive function limitations (18)(19)(20), and it has further been suggested that early injections may be helpful in preventing contracture development, with potential to unmask active functional improvement (18,21). Indeed, exploratory analyses of studies of abobotulinumtoxinA in upper limb spasticity management have suggested that the most influential factors predicting goal achievement are previous treatment status (whether the patients were de novo or had been previously treated with BoNT-A) and time since spasticity onset as well as the spasticity pattern, and overall injection dose (22).…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of AbobotulinumtoxinA in Post-stroke Upper Limb Spasticity in Relation to Timing of Treatment

Wissel

Fheodoroff²,

Müngersdorf³

et al. 2020

Front. Neurol.

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Background: Recent studies of botulinum toxin for post-stroke spasticity indicate potential benefits of early treatment (i. e., first 6 months) in terms of developing hypertonicity, pain and passive function limitations. This non-interventional, longitudinal study aimed to assess the impact of disease duration on the effectiveness of abobotulinumtoxinA treatment for upper limb spasticity. Methods: The early-BIRD study (NCT01840475) was conducted between February 2013 and 2018 in 43 centers across Germany, France, Austria, Netherlands and Switzerland. Adult patients with post-stroke upper limb spasticity undergoing routine abobotulinumtoxinA treatment were followed for up to four treatment cycles. Patients were categorized by time from stroke event to first botulinum toxin-A treatment in the study (as defined by the 1st and 3rd quartiles time distribution) into early-, medium-and late-start groups. We hypothesized that the early-start group would show a larger benefit (decrease) as assessed by the modified Ashworth scale (MAS, primary endpoint) on elbow plus wrist flexors compared with the late-start group. Results: Of the 303 patients enrolled, 292 (96.4%) received ≥1 treatment and 186 (61.4%) received 4 injection cycles and completed the study. Patients in all groups showed a reduction in MAS scores from baseline over the consecutive injection visits (i.e., at end of each cycle). Although reductions in MAS scores descriptively favored the early treatment group, the difference compared to the late group did not reach statistical significance at the last study visit (ANCOVA: difference in adjusted means of 0.15, p = 0.546). Conclusions: In this observational, routine-practice study, patients in all groups displayed a benefit from abobotulinumtoxinA treatment, supporting the effectiveness of treatment for patients at various disease stages. Although the data revealed some trends in favor of early vs. late treatment, we did not find strong evidence for a significant benefit of early vs. late start of treatment in terms of reduction in MAS scores.

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effectiveness of AbobotulinumtoxinA in Post-stroke Upper Limb Spasticity in Relation to Timing of Treatment

Wissel

Fheodoroff²,

Müngersdorf³

et al. 2020

Front. Neurol.

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“…Moreover, aboBoNT-A has been shown to be an effective focal intervention for reducing upper limb spastic paresis over single [12,15] and repeated treatment cycles [31], with efficacy lasting up to 20 weeks [12], and exceeding 28 weeks when injected early post-stroke [32]. Funding of aboBoNT-A for post-stroke ULS treatment in Poland was approved in 2014.…”

Section: Introductionmentioning

confidence: 99%

Real-world effectiveness of abobotulinumtoxinA (Dysport®) in adults with upper limb spasticity in routine clinical practice: an observational study

Sarzyńska‐Długosz

Szczepańska-Szerej

Drużdż³

et al. 2020

Neurol Neurochir Pol.

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AbobotulinumtoxinA (aboBoNT-A, Dysport®) is used in clinical practice as a well-tolerated and effective therapy for muscle spasticity. AboBoNT-A has been shown to reduce upper and lower limb spastic paresis in clinical trials, demonstrating improvements in muscle tone and limb function. This open-label, multicentre, observational, non-interventional study was the first to investigate aboBoNT-A's efficacy in adult patients with upper limb spasticity (ULS) in routine clinical practice in Poland. All enrolled patients received ≥1 aboBoNT-A injection cycles, per routine clinical practice (full analysis set, FAS), and ≥1 rehabilitation session. Patients attended a baseline visit (V1) and two follow-up visits (V2, V3) for retreatment, depending on the investigator's assessment of individual patient needs, with a mean interval (SD) between injections of 4.4 (1.4) and 4.5 (1.2) months. The primary effectiveness endpoint was patient-and physician-based evaluation using the Clinical Global Impression-Improvement Scale (CGI-I), a validated 7-point scale (1 = very much improved to 7 = very much worse) relative to baseline. CGI-I has not previously been used as a primary endpoint in studies evaluating ULS. Secondary endpoints included muscle tone in shoulder, elbow, carpal joint, and finger muscles, measured by the Modified Ashworth Scale (MAS), and muscle strength according to the Medical Research Council scale (MRC). Of 108 enrolled patients (FAS), 92 (85.2%) completed the study and 57 (52.8%) were included in the per protocol (PP) population. AboBoNT-A improved patient conditions in 96.4% and 98.6% at V2 and V3 (investigator assessment) and 92.8% and 98.6% (as reported by patient) of patients, respectively. Significant reductions in muscle tone from baseline were observed at both visits (p < 0.0001-0.0077) across muscle groups. Increased muscle strength by cumulative MRC was observed at V2 (p = 0.0566) and V3 (p = 0.0282) versus baseline. Safety was consistent with the known profile of aboBoNT-A. In conclusion, aboBoNT-A treatment is beneficial in patients with post-stroke ULS in routine clinical practice, assessed by patients and investigators.

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“…Botulinum toxin injections have also demonstrated significant greater global benefit, but no significant difference in quality of life (QOL) of stroke patients. In a study performed by McCrory et al, which used 2 injections of BoT in the distal spastic upper limb at 12 weeks interval, no significant benefit in improving quality of life was demonstrated using the AQoL (Assessment of Quality of Life) scale [24]. The possible explanation for lack of effect of BoT treatment on patient's quality of life is that BoT treatment should not be seen as a treatment in isolation, but as part of a more comprehensive treatment strategy that also involves physiotherapy, bracing, balneotherapy with the use of natural therapeutic factors and pharmacotherapy [25].…”

Section: Introductionmentioning

confidence: 97%

Spasticity in post-stroke patients: incidence and therapeutical approach

Stănescu¹,

Dogaru²,

Bulboacă³

et al. 2018

Balneo

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Stroke is a leading cause of serious long-term disability: about one third of patients developing spasticity of the affected limbs. Spasticity is characterized by a velocity-dependent increase in resistance to passive movement, and is one of the "positive signs" of upper motor neuron syndrome. Spasticity induces pain, ankylosis, tendon retraction, increasing motor deficit, which may limit the efficacy of rehabilitation methods . Spasticity is also correlated with activity limitations, and reduces quality of life of patients and caregivers. Assessment of post-stroke spasticity requires first clinical examination; scales as Ashworth Modifyed scale and Tardieu Modifyed scale are useful quantitative tools. Treatment of spasticity is often challenging for the rehabilitation team, requiring a multidisciplinary approach. Therapeutic interventions include physical therapy, occupational therapy, use of assistive devices, pharmacological treatment and injectable treatment. Botulinum toxin injections in spastic upper and lower limb muscles have significant effect in reducing muscle tone and improving passive function in affected limbs, and should also be considered for improvement of active function.

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Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study

Cited by 39 publications

References 36 publications

Effectiveness of AbobotulinumtoxinA in Post-stroke Upper Limb Spasticity in Relation to Timing of Treatment

Effectiveness of AbobotulinumtoxinA in Post-stroke Upper Limb Spasticity in Relation to Timing of Treatment

Real-world effectiveness of abobotulinumtoxinA (Dysport®) in adults with upper limb spasticity in routine clinical practice: an observational study

Spasticity in post-stroke patients: incidence and therapeutical approach

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