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

Misra, V.P.; Colosimo, Carlo; Charles, David; Chung, Tae Mo; Maisonobe, Pascal; Om, Savary

doi:10.1007/s00415-017-8698-2

Cited by 15 publications

(17 citation statements)

References 23 publications

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“…1). Baseline characteristics for the MSP population are presented in Table 1 and were similar to the interim data previously reported [22]. Most subjects were female (68.0% overall) and the mean ± SD age was 54.8 ± 13.1.…”

Section: Resultssupporting

confidence: 68%

“…INTEREST IN CD2 (NCT01753349) was a 3-year multicentre longitudinal cohort study following the course of adult idiopathic CD patients treated with BoNT-A. Baseline analyses have previously been reported [22]. The study was conducted in compliance with the International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP) [23]; it began on 10 December 2012 and the last visit occurred on 25 September 2017.…”

Section: Methodsmentioning

confidence: 99%

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How satisfied are cervical dystonia patients after 3 years of botulinum toxin type A treatment? Results from a prospective, long-term observational study

et al. 2019

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BackgroundPatients with cervical dystonia (CD) typically require regular injections of botulinum toxin to maintain symptomatic control. We aimed to document long-term patient satisfaction with CD symptom control in a large cohort of patients treated in routine practice.MethodsThis was a prospective, international, observational study (NCT01753349) following the course of adult CD treated with botulinum neurotoxin type A (BoNT-A) over 3 years. A comprehensive clinical assessment status was performed at each injection visit and subjects reported satisfaction in two ways: satisfaction with symptom control at peak effect and at the end of treatment cycle.ResultsSubject satisfaction remained relatively stable from the first to the last injection visit. At 3 years, 89.9% of subjects reported satisfaction with symptom control at peak effect and 55.6% reported satisfaction with symptom control at end of treatment cycle. By contrast, objective ratings of CD severity showed an overall reduction over 3 years. Mean ± SD Toronto Western Spasmodic Rating Scale (TWSTRS) Total scores (clinician assessed at end of treatment cycle) decreased from 31.59 ± 13.04 at baseline to 24.49 ± 12.43 at 3 years (mean ± SD reduction from baseline of − 6.97 ± 11.56 points). Tsui scale scores also showed gradual improvement; the percent of subjects with a tremor component score of 4 reduced from 12.4% at baseline to 8.1% at 3 years.ConclusionsDespite objective clinical improvements over 3 years, subject satisfaction with symptom control remained relatively constant, indicating that factors other than symptom control also play a role in patient satisfaction.Electronic supplementary materialThe online version of this article (10.1007/s00415-019-09527-2) contains supplementary material, which is available to authorized users.

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Section: Resultssupporting

confidence: 68%

Section: Methodsmentioning

confidence: 99%

How satisfied are cervical dystonia patients after 3 years of botulinum toxin type A treatment? Results from a prospective, long-term observational study

et al. 2019

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“…Patients suffering from dystonia reported more problems with daily activities, e.g., mobility and self-care (Gudex et al 1998). In addition, only a minority of the patients reported complete satisfaction with their treatment at the end of a botulinum toxin (BT) therapy cycle as recently shown in large study groups (Colosimo et al 2019;Misra et al 2018). This is in line with our observation on decreased HR-QoL, as we detected a persistent reduction in patients' SF-36 scores, even under chronic treatment with BT, compared to general German population data.…”

Section: Hr-qol In Dystonia Patientsmentioning

confidence: 94%

Caregiver burden and health-related quality of life in idiopathic dystonia patients under botulinum toxin treatment: a cross-sectional study

et al. 2019

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Dystonia is a chronic movement disorder that is associated with a reduction in health-related quality of life (HR-QoL) and restriction of activities of daily living. Botulinum neurotoxin (BT) improves disease-specific HR-QoL by reducing abnormal movements, postures, and pain. We examined the burden of the corresponding primary caregiver as a potential important factor for disease management and HR-QoL of dystonia patients under treatment with BT. 114 patients with focal, segmental, or generalized dystonia were recruited, together with 93 corresponding caregivers, whose burden was investigated using the Caregiver Burden Inventory. In addition, all participants were assessed for cognitive impairment, depression, anxiety, alexithymia, and HR-QoL. Only a small proportion of caregivers suffered from caregiver burden. Despite BT therapy, patients' HR-QoL was decreased compared to the age-matched general German population. Psychological symptoms, notably anxiety, and depression correlated significantly with reduced HR-QoL. Our data imply that caregiver burden emerged to be an issue in subgroups of dystonia patients. Furthermore, HR-QoL of dystonia patients is reduced even under optimized BT treatment in a specialized center.

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“…The database includes subject baseline data from the three prospective, observational studies which have followed the course of adult CD subjects treated with BoNT-A (Table 1 ). The methodology and results from the individual studies have been published in detail elsewhere [ 16 – 18 ].…”

Section: Methodsmentioning

confidence: 99%

“…The methodology and results from the individual studies have been published in detail elsewhere [ 16 – 18 ].…”

Section: Methodsmentioning

confidence: 99%

Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

Misra

Trosch²,

Maisonobe

et al. 2018

J Clin Mov Disord

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BackgroundCervical dystonia is a heterogeneous disorder with several possible presentations, for which first-line therapy is often botulinum toxin (BoNT). In routine clinical practice the success of each BoNT injection is dependent on several variables, including individual presentation and injection technique. Large multicenter, observational studies provide important information on individualized administration strategies that cannot be otherwise ascertained from controlled clinical trials. In this meta-analysis of patient level data, we aimed to evaluate the clinical characteristics of patients with cervical dystonia undergoing routine treatment with botulinum toxin, specifically abobotulinumtoxinA. We also aimed to characterize current abobotulinumtoxinA injection techniques and parameters and to explore international differences in patient presentation and treatment.MethodsThis was a meta-analysis of baseline data from three prospective, international, multicenter, observational studies (NCT01314365, NCT00833196 and NCT01753349) of botulinum toxin treatment for the routine management of adult cervical dystonia.ResultsData presented illustrate the significant heterogeneity of CD presentation in routine practice. Most subjects presented with a complex pattern of dystonic movements and the majority had additional components of shoulder elevation, tremor and/or jerk. Dosing was generally in accordance with that recommended in the abobotulinumtoxinA prescribing information, although the range of dosing also indicates that injections are tailored to individual presentation. Sub-group analyses at the country level revealed distinct differences in injection practice.ConclusionsThis meta-analysis is based on the largest dataset of subjects with cervical dystonia studied to date. The heterogeneity revealed in our baseline findings support the need to develop consistent, practical and comprehensive best practice guidelines.

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

Cited by 15 publications

References 23 publications

How satisfied are cervical dystonia patients after 3 years of botulinum toxin type A treatment? Results from a prospective, long-term observational study

How satisfied are cervical dystonia patients after 3 years of botulinum toxin type A treatment? Results from a prospective, long-term observational study

Caregiver burden and health-related quality of life in idiopathic dystonia patients under botulinum toxin treatment: a cross-sectional study

Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

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