Multicenter observational study of abobotulinumtoxinA neurotoxin in cervical dystonia: The ANCHOR-CD registry

Trosch, Richard; Espay, Alberto J.; Truong, Daniel D.; Gil, Ramon; Singer, Carlos; LeWitt, Peter A.; Lew, Mark F.; Tagliati, Michele; Adler, Charles H.; Chen, Jack J.; Marchese, Dominic; Comella, Cynthia L.

doi:10.1016/j.jns.2017.02.042

Cited by 32 publications

(31 citation statements)

References 12 publications

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“…We believe that the strengths of this study include its size, truly global nature and inclusion of all BoNT-A products. Other studies have been restricted to one product and often one country [ 24 – 26 ]. The study has several limitations including smaller subject numbers in certain regions and site selection bias.…”

Section: Discussionmentioning

confidence: 99%

INTEREST IN CD2, a global patient-centred study of long-term cervical dystonia treatment with botulinum toxin

et al. 2017

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BackgroundLongitudinal cohort studies provide important information about the clinical effectiveness of an intervention in the routine clinical setting, and are an opportunity to understand how a population presents for treatment and is managed.MethodsINTEREST IN CD2 (NCT01753349) is a prospective, international, 3-year, longitudinal, observational study following the course of adult idiopathic cervical dystonia (CD) treated with botulinum neurotoxin type A (BoNT-A). The primary objective is to document long-term patient satisfaction with BoNT-A treatment. Here we report baseline data.ResultsThis analysis includes 1036 subjects (67.4% of subjects were female; mean age was 54.7 years old; mean TWSTRS Total score was 31.7). BoNT-A injections were usually given in line with BoNT-A prescribing information. The most commonly injected muscles were splenius capitis (87.3%), sternocleidomastoid (82.6%), trapezius (64.3%), levator scapulae (40.9%) and semispinalis capitis (26.9%); 35.5% of subjects were injected using a guidance technique. Most subjects (87.8%) had been previously treated with BoNT-A (median interval between last pre-study injection and study baseline was 4 months); of these 84.8% reported satisfaction with BoNT-A treatment at peak effect during their previous treatment cycle and 51.5% remained satisfied at the end of the treatment. Analyses by geographical region revealed heterogeneity in the clinical characteristics and BoNT-A injection practice of CD subjects presenting for routine treatment.ConclusionsThese baseline analyses provide sizeable data regarding the epidemiology and clinical presentation of CD, and demonstrate an international heterogeneity of clinical practice. Future longitudinal analyses of the full 3-year study will explore how these factors impact treatment satisfaction.Electronic supplementary materialThe online version of this article (10.1007/s00415-017-8698-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

INTEREST IN CD2, a global patient-centred study of long-term cervical dystonia treatment with botulinum toxin

et al. 2017

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“…30 Another observational study, the abobotulinumtoxinA neurotoxin in cervical dystonia (ANCHOR-CD) registry, evaluated the effectiveness of aboBoNT/A in 350 patients with cervical dystonia (75% women; mean age 59 6 13.6years; 27.4% botulinum neurotoxin-na€ ıve). 31 At a median dose of 500 units, the responder rate was 30.6% (n 5 304), and the TWSTRS total score decreased 27.4% from baseline to week 4. The Patient Global Impression of Change score of at least "much improved" was reported in 43.3% to 52.8% in cycles 1 to 4.…”

Section: Clinical Use Of Bontmentioning

confidence: 93%

“…Of those currently employed, cervical dystonia affected work status in 26.0%, particularly because of pain and anterocollis/retrocollis, but dystonia‐related absenteeism was significantly decreased following onaBoNT/A . Another observational study, the abobotulinumtoxinA neurotoxin in cervical dystonia (ANCHOR‐CD) registry, evaluated the effectiveness of aboBoNT/A in 350 patients with cervical dystonia (75% women; mean age 59 ± 13.6years; 27.4% botulinum neurotoxin‐naïve) . At a median dose of 500 units, the responder rate was 30.6% (n = 304), and the TWSTRS total score decreased 27.4% from baseline to week 4.…”

Section: Clinical Use Of Bontmentioning

confidence: 99%

Botulinum toxin: State of the art

2017

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Botulinun neurotoxin (BoNT) has emerged as one of the most multipurpose therapeutic agents in modern medicine with more clinical applications than any other drug currently on the market. Initially developed in the treatment of strabismus and neurologic movement disorders, the use of botulinun neurotoxin has been expanding during the past 3 decades to include the treatment of a variety of ophthalmologic, gastrointestinal, urologic, orthopedic, dermatologic, dental, secretory, painful, cosmetic, and other conditions. In addition to onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), and RimabotulinumtoxinB (Myobloc or NeuroBloc) there are other novel botulinun neurotoxin products currently in development. With a better understanding of the cellular mechanisms of botulinun neurotoxin and advances in biotechnology, future botulinun neurotoxin products will likely be even more effective and customized to the specific indication and tailored to the needs of the patients. © 2017 International Parkinson and Movement Disorder Society.

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“…CD includes abnormal posturing and involuntary movements of the head and neck. In this sense, a robust and well-reproduced motor effect has been demonstrated in CD ( 6 , 7 ). However, HR-QoL does not linearly relate to motor response but incorporates multivariate modifiers including non-motor features ( 4 ).…”

Section: Introductionmentioning

confidence: 68%

Botulinumtoxin Improves both Generic and Disease-Specific Quality of Life in Cervical Dystonia

et al. 2017

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Botulinumtoxin injection (BoNT) into affected muscles is effective to improve motor symptoms of cervical dystonia (CD) by reducing muscle contraction and involuntary dystonic movement and posturing. However, the understanding of the effect on health-related quality of life (HR-QoL) and patient referral under HR-QoL aspects is incomplete. In this open-label clinical prospective observational study, we characterized the outcomes in CD (n = 159) from botulinumtoxin on both generic HR-QoL (EuroQol; EQ-5D-5L) and disease-specific HR-QoL [craniocervical dystonia questionnaire (CDQ-24)]. Additionally, we characterized motor and non-motor signs of dystonia including motor symptom improvement, depressive symptoms, pain, and sleep quality. We assessed patients at the end of a regular 3-month period from last injection (Timepoint1) and 4 weeks after the re-injection of BoNT (Timepoint2). We aimed to define outcomes on both generic and disease-specific HR-QoL and to evaluate predictors of therapeutic outcome in terms of stepwise multiple regression models. Patients with CD showed a robust improvement of both generic and disease-specific HR-QoL. Furthermore, motor and non-motor signs improved. Multiple regression analyses revealed that EQ-5D-5L and “satisfaction with health” (Fragen zur Lebenszufriedenheit-G) at Timepoint1 predicted treatment response on generic HR-QoL outcome (R2 = 0.284; P = 0.019). Similarly, CDQ-24 and Beck’s Depression inventory at Timepoint1 predicted the treatment response on disease-specific HR-QoL (R2 = 0.253; P = 0.026). Our study underscores both generic and disease-specific HR-QoL improvements in CD, and provides useful predictors on HR-QoL outcomes.

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Multicenter observational study of abobotulinumtoxinA neurotoxin in cervical dystonia: The ANCHOR-CD registry

Abstract: This study confirmed the beneficial effect of abobotulinumtoxinA on CD in routine clinical practice as measured by improvements in TWSTRS and PGIC. No new safety concerns were identified.

Cited by 32 publications

References 12 publications

INTEREST IN CD2, a global patient-centred study of long-term cervical dystonia treatment with botulinum toxin

INTEREST IN CD2, a global patient-centred study of long-term cervical dystonia treatment with botulinum toxin

Botulinum toxin: State of the art

Botulinumtoxin Improves both Generic and Disease-Specific Quality of Life in Cervical Dystonia

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