Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies

Esquenazi, Alberto; Delgado, Mauricio R.; Hauser, Robert A.; Picaut, Philippe; Foster, Keith A.; Lysandropoulos, Andreas; Graciès, Jean Michel

doi:10.3389/fneur.2020.576117

Cited by 17 publications

(21 citation statements)

References 40 publications

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“…These results are consistent with those presented in a similar analysis of the duration of treatment effect in four clinical studies with abobotulinumtoxinA (22), which included data from an OLEX study of abobotulinumtoxinA ≤1,500 U at intervals ≥12 weeks for the treatment of upper-limb spasticity (23). During this OLEX study, 34.9% of subjects received a second injection at Week ≥16, and 24.0% received a third injection at Week ≥16 (22,23). However, while abobotulinumtoxinA reinjections were possible only at fixed visits every 4 weeks from Week 12 to Week 24 post-treatment (22,23), the design of the current incobotulinumtoxinA study allowed for full flexibility in the timing of the visits, thereby avoiding artificial overestimation of the duration of treatment effect.…”

Section: Discussionsupporting

confidence: 92%

“…Results demonstrate a duration of treatment effect beyond 12 weeks with incobotulinumtoxinA in subjects with post-stroke upperlimb spasticity, with 31.1% of all reinjections performed at 16 weeks or longer following the previous treatment and 60.3% of subjects having at least one injection interval of 16 weeks or longer. These results are consistent with those presented in a similar analysis of the duration of treatment effect in four clinical studies with abobotulinumtoxinA (22), which included data from an OLEX study of abobotulinumtoxinA ≤1,500 U at intervals ≥12 weeks for the treatment of upper-limb spasticity (23). During this OLEX study, 34.9% of subjects received a second injection at Week ≥16, and 24.0% received a third injection at Week ≥16 (22,23).…”

Section: Discussionsupporting

confidence: 87%

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Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

et al. 2021

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The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 87%

Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

et al. 2021

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“…Most clinical studies have not prospectively looked at time to symptom re-emergence/waning of effect. A recent review of the abobotulinumtoxinA clinical literature approached this question by reviewing the time to retreatment (i.e., length of injection intervals when patients were retreated according to investigator judgement) as an alternative metric and reported that in CD clinical trials, 72.6-81.5% of abobotulinumtoxinA patients did not require retreatment before 16 weeks [19].…”

Section: Discussionmentioning

confidence: 99%

Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia

et al. 2020

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Background Botulinum neurotoxin type A (BoNT-A) is an effective pharmacological treatment for the management of cervical dystonia (CD) that requires repeated administration at variable intervals. We explored patient perceptions of the impact of CD and the waning of BoNT-A therapeutic effects. Methods An internet-based survey was conducted through Carenity, a global online patient community, from May to September 2019. Eligible respondents were adults with CD who had ≥ 2 previous BoNT-A injections. Results 209 respondents (81% females; mean age of 49.7 years) met the screening criteria. The mean BoNT-A injection frequency was 3.9 injections/year. The mean reported onset of BoNT-A therapeutic effect was 11.7 days and the time to peak effect was 4.5 weeks. Symptom re-emergence between injections was common (88%); the time from injection to symptom re-emergence was 73.6 days (~ 10.5 weeks). Treatment was not reported to completely abolish symptoms, even at peak effect. However, symptom severity was rated (0 = no symptoms; 10 = very strong symptoms) as lowest at the peak of treatment effects (mean scores ~ 3/10), increasing as the effects of treatment start waning (~ 5.5/10) and was strongest one day before the next session (~ 7–8/10). The impact of CD on quality of life followed the same ‘rollercoaster’ pattern. Conclusions This survey highlights the burden of CD symptoms, even in patients undergoing regular treatment. Symptom re-emergence is common and has significant impact on daily activities and quality of life. Greater awareness of the therapeutic profile of BoNT-A treatment should lead to better informed therapeutic discussions and planning.

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“…These data collectively suggest that the option of a longer-acting BoNT-A formulation would be favorably received by patients and their caregivers, to provide sustained relief from spasticity symptoms and to overcome practical issues associated with more frequent treatment, as suggested in another patient survey [ 38 ]. A recent clinical review indicates that aboBoNT-A treatment may allow long intervals between injections, suggesting long-term symptom relief [ 39 ] . These data appear to be corroborated by real-world evidence [ 40 ] and may be explained by recent preclinical research showing that aboBoNT-A contains more active neurotoxin at licensed doses than other BoNT products [ 41 ].…”

Section: Discussionmentioning

confidence: 99%

Perspective of an International Online Patient and Caregiver Community on the Burden of Spasticity and Impact of Botulinum Neurotoxin Therapy: Survey Study

Patel¹,

Wein

Bahroo

et al. 2020

JMIR Public Health Surveill

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Background Patient- and caregiver-reported data are lacking on the burden of spasticity, and the impact of botulinum neurotoxin type A (BoNT-A) treatment for this condition, on patients' daily lives. As recommended in recent guidance from the US Food and Drug Administration, online patient communities can represent a platform from which to gather specific information outside of a clinical trial setting on the burden of conditions experienced by patients and caregivers and their views on treatment options in order to inform evidence-based medicine and drug development. Objective The objective of our study is to characterize spasticity symptoms and their associated burdens on Western European and US patients and caregivers in the realms of work, daily activities, quality of life (QoL), as well as the positive and negative impacts of treatment with BoNT-A (cost, time, QoL) using Carenity, an international online community for people with chronic health conditions. Methods We performed a noninterventional, multinational survey. Eligible participants were 18 years old or older and had, or had cared for, someone with spasticity who had been treated with BoNT-A for at least 1 year. Patients and caregivers were asked to complete an internet-based survey via Carenity; caregivers reported their own answers and answered on behalf of their patients. Questions included the burden of spasticity on the ability to work, functioning, daily-living activities, and QoL, the impact of BoNT A therapy on patients' lives, and the potential benefits of fewer injections. Results There were 615 respondents (427 patients and 188 caregivers). The mean age of patients and caregivers was 41.7 years and 38.6 years, respectively, and the most commonly reported cause of spasticity was multiple sclerosis. Caregivers were most often the parents (76/188, 40%) or another family member (51/188, 27%) of their patients. Spasticity had a clear impact on patients' and caregivers' lives, including the ability to work and injection costs. For patients, spasticity caused difficulties with activities of daily living and reduced QoL indices. The median number of BoNT-A injections was 4 times per year, and 92% (393/427) of patients reported that treatment improved their overall satisfaction with life. Regarding the BoNT-A injection burden, the greatest patient-reported challenges were the cost and availability of timely appointments. Overall, 86% (368/427) of patients believed that a reduced injection frequency would be beneficial. Caregivers answering for their patients gave largely similar responses to those reported by patients. Conclusions Spasticity has a negative impact on both patients' and caregivers' lives. All respondents reported that BoNT A treatment improved their lives, despite the associated challenges. Patients believed that reducing the frequency of BoNT-A injections could alleviate practical issues associated with treatment, implying that a longer-acting BoNT-A injection would be well received.

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Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies

Cited by 17 publications

References 40 publications

Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

Duration of Treatment Effect Using IncobotulinumtoxinA for Upper-limb Spasticity: A Post-hoc Analysis

Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia

Perspective of an International Online Patient and Caregiver Community on the Burden of Spasticity and Impact of Botulinum Neurotoxin Therapy: Survey Study

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