Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study

Comella, Cynthia L.; Hauser, Robert A.; Isaacson, Stuart; Truong, Daniel D.; Oguh, Odinachi; Hui, Jennifer; Molho, Eric; Brodsky, Matthew; Furr-Stimming, Erin; Comes, Georg; Hast, Michael A.; Charles, David

doi:10.1016/j.prdoa.2022.100142

Cited by 6 publications

(18 citation statements)

References 16 publications

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“…Injection schedules, doses and approaches (either ultrasound or anatomical landmark guidance) of BTX varies in clinical practice. Notably, studies have revealed that different injection schedules and doses of BTX might be associated with different efficacies and risks of TRAEs 13 14 45. In these eligible studies included in the present systematic review and meta-analysis, the injection dose of BTX can be as small as a few IU per limb in the study by Lindholm et al in 201738 and as large as intramuscular injections of 5000 units of BTX into the soleus-gastrocnemius complex of the predominantly affected leg in the study by Fernandez et al in 2004 34.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of botulinum toxin for treating motor dysfunction in patients with Parkinson’s disease: a systematic review and meta-analysis

et al. 2023

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ObjectiveTo evaluate the efficacy and safety of botulinum toxin (BTX) for motor dysfunction in Parkinson’s disease (PD).DesignSystematic review and meta-analysis.Data sourcesSearches of PubMed, EMBASE and the Cochrane Library, from database inception to 20 October 2022.Eligibility criteriaStudies reported in English with adult PD patients treated with BTX.Data extraction and synthesisPrimary outcomes were United Parkinson’s Disease Rate Scale Section (UPDRS) III (or its items) and Visual Analogue Scale (VAS). Secondary outcomes were UPDRS-II (or its items), Freezing of Gait Questionnaire (FOG-Q), Timed Up and Go test (TUG) and treatment-related adverse events (TRAEs). Mean difference (MD) or standardised MD (SMD) before and after treatment with 95% CIs were used for continuous variables and risk ratios (RRs) with 95% CIs was used for TRAEs.ResultsSix randomised controlled trials (RCTs) and six non-RCTs (case series) were included (ntotal=224 participants, nRCT=165). No significant difference was found in pooled results of UPDRS-III (available in four RCTs and two non-RCTs, SMD=−0.19, 95% CI −0.98 to 0.60), UPDRS-II (four RCTs and one non-RCT, SMD=−0.55, 95% CI −1.22 to 0.13), FOG-Q (one RCT and one non-RCT, SMD=0.53, 95% CI −1.93 to 2.98) or the risk of TRAEs (five RCTs, RR 0.87, 95% CI 0.37 to 2.01). Significant decreases were found in pooled VAS score (three RCTs and five non-RCTs, MD=−2.14, 95% CI −3.05 to −1.23) and TUG (MD=−2.06, 95% CI −2.91 to −1.20) after BTX treatment.ConclusionsBTX may not be associated with motor symptoms alleviation, although it benefits pain alleviation and functional mobility improvement.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of botulinum toxin for treating motor dysfunction in patients with Parkinson’s disease: a systematic review and meta-analysis

et al. 2023

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“…Previous studies of BoNT-A treatment in CD have shown persistent reductions in pain during long-term treatment with aboBoNT-A [ 33 , 34 ], onaBoNT-A [ 5 , 35 ], and incoBoNT-A [ 21 , 27 , 28 ] when pain was scored using the TWSTRS and/or a pain numeric rating scale. A ≥30% improvement from baseline in pain score was also noted in a large cohort of patients with moderate-to-severe pain treated with onaBoNT-A in the CD-PROBE observational study [ 24 ] and in a meta-analysis of observational studies of aboBoNT-A in patients with CD [ 26 ], supporting the use of ≥30% reduction in pain as a clinically relevant measure.…”

Section: Discussionmentioning

confidence: 99%

“…The TWSTRS covers a range of CD features, including disease severity, functional ability, and pain [ 36 ]. IncoBoNT-A has been shown to effectively control CD symptoms after each injection, as reflected by improvements in the TWSTRS total score and TWSTRS subscale scores for motor severity, disability, and pain [ 19 , 20 , 21 , 27 , 28 ]. However, the TWSTRS does have several drawbacks, including its complexity for use in clinical practice and it does not consider the location of pain [ 36 ], which may lead to an underestimation of pain severity.…”

Section: Discussionmentioning

confidence: 99%

“…We also did not examine changes in the TWSTRS disability score in this pooled analysis. However, it is well known that pain contributes to disability in CD [ 11 ] and that BoNT treatment, including incoBoNT-A, reduces both pain and disability [ 20 , 21 , 27 , 28 , 37 ]. A recent case-control study found that patients with CD-related pain had significantly higher TWSTRS severity and disability scores than those without pain and that pain reduction following BoNT injection lasted longer than muscle relaxation in 85.3% of patients with pain, although muscle relaxation preceded pain improvement for 53% of these patients [ 8 ].…”

Section: Discussionmentioning

confidence: 99%

“…The aim of this analysis was to investigate the impact of incoBoNT-A on pain related to CD by pooling data from four incoBoNT-A studies in the treatment of CD in adults [ 19 , 20 , 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

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Pain Reduction in Cervical Dystonia Following Treatment with IncobotulinumtoxinA: A Pooled Analysis

Albanese

Wissel

Jost

et al. 2023

Toxins

Self Cite

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This analysis pooled pain severity data from four phase 3 and 4 studies of incobotulinumtoxinA (incoBoNT-A) for the treatment of cervical dystonia (CD) in adults. CD-related pain severity was assessed at baseline, each injection visit, and 4 weeks after each injection of incoBoNT-A using the Toronto Western Spasmodic Torticollis Rating Scale pain severity subscale or a pain visual analog scale. Both were analyzed using a score range of 0–10 and pain was categorized as mild, moderate, or severe. Data for 678 patients with pain at baseline were assessed and sensitivity analyses evaluated pain responses in the subgroup not taking concomitant pain medication (n = 384 at baseline). At Week 4 after the first injection, there was a mean change of −1.25 (standard deviation 2.04) points from baseline pain severity (p < 0.0001), with 48.1% showing ≥ 30% pain reduction from baseline, 34.4% showing ≥50% pain reduction from baseline, and 10.3% becoming pain free. Pain responses were sustained over five injection cycles with a trend to incremental improvements with each successive cycle. Pain responses in the subgroup not taking concomitant pain medication demonstrated the lack of confounding effects of pain medications. These results confirmed the pain relief benefits of long-term treatment with incoBoNT-A.

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Isolated head tremor

Zalyalova,

Ermakova,

Khayatova

2024

RJTAO

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Isolated head tremor (IHT) is a pathological condition characterized by tremor of the head without dystonic posturing or tremor in other parts of the body. In the past, head tremor was commonly referred to as essential tremor because it is very common in families of patients with essential tremor and may precede hand tremor. Several recent observations cast doubt on this theory. The irregular character of the tremor, the low efficacy of the drugs used for essential tremor and the use of botulinum neuroprotein type A with good response point to the dystonic character of the tremor. Neurophysiological evidence for a relationship between IHT and dystonia includes an altered somatosensory temporal discrimination threshold, metabolic changes according to DAT spectrography (positron emission spectrography to determine changes in dopamine levels) and a change in the blink reflex.

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Efficacy and safety of two incobotulinumtoxinA injection intervals in cervical dystonia patients with inadequate benefit from standard injection intervals of botulinum toxin: Phase 4, open-label, randomized, noninferiority study

Cited by 6 publications

References 16 publications

Efficacy and safety of botulinum toxin for treating motor dysfunction in patients with Parkinson’s disease: a systematic review and meta-analysis

Efficacy and safety of botulinum toxin for treating motor dysfunction in patients with Parkinson’s disease: a systematic review and meta-analysis

Pain Reduction in Cervical Dystonia Following Treatment with IncobotulinumtoxinA: A Pooled Analysis

Isolated head tremor

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