Top

Published in:

Open Access 01-02-2018 | Original Communication

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

Authors: Vijay P. Misra, Carlo Colosimo, David Charles, Tae Mo Chung, Pascal Maisonobe, Savary Om, On behalf of the INTEREST IN CD2 study group

Published in: Journal of Neurology | Issue 2/2018

Abstract

Background

Longitudinal 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.

Methods

INTEREST 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.

Results

This 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.

Conclusions

These 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.

Available only for authorised users

Stacy M (2008) Epidemiology, clinical presentation, and diagnosis of cervical dystonia. Neurol Clin 26(Suppl 1):23–42CrossRefPubMed

Chan J, Brin MF, Fahn S (1991) Idiopathic cervical dystonia: clinical characteristics. Mov Disord 6(2):119–126. https://doi.org/10.1002/mds.870060206 CrossRefPubMed

Defazio G, Jankovic J, Giel JL, Papapetropoulos S (2013) Descriptive epidemiology of cervical dystonia. Tremor Other Hyperkinet Mov (N Y). https://doi.org/10.7916/d80c4tgj

Ben-Shlomo Y, Camfield L, Warner T (2002) What are the determinants of quality of life in people with cervical dystonia? J Neurol Neurosurg Psychiatry 72(5):608–614CrossRefPubMedPubMedCentral

Pekmezovic T, Svetel M, Ivanovic N, Dragasevic N, Petrovic I, Tepavcevic DK, Kostic VS (2009) Quality of life in patients with focal dystonia. Clin Neurol Neurosurg 111(2):161–164. https://doi.org/10.1016/j.clineuro.2008.09.023 CrossRefPubMed

Muller J, Kemmler G, Wissel J, Schneider A, Voller B, Grossmann J, Diez J, Homann N, Wenning GK, Schnider P, Poewe W, Austrian Botulinum T, Dystonia Study G (2002) The impact of blepharospasm and cervical dystonia on health-related quality of life and depression. J Neurol 249(7):842–846. https://doi.org/10.1007/s00415-002-0733-1 CrossRefPubMed

Comella C, Bhatia K (2015) An international survey of patients with cervical dystonia. J Neurol. https://doi.org/10.1007/s00415-014-7586-2 PubMedPubMedCentral

Albanese A, Asmus F, Bhatia KP, Elia AE, Elibol B, Filippini G, Gasser T, Krauss JK, Nardocci N, Newton A, Valls-Sole J (2011) EFNS guidelines on diagnosis and treatment of primary dystonias. Eur J Neurol 18(1):5–18. https://doi.org/10.1111/j.1468-1331.2010.03042.x CrossRefPubMed

Simpson DM, Hallett M, Ashman EJ (2016) Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache. Neurology 86:1–9CrossRef

10.

Misra VP, Ehler E, Zakine B, Maisonobe P, Simonetta-Moreau M (2012) Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study. BMJ Open. https://doi.org/10.1136/bmjopen-2012-000881

11.

Basch E (2012) Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels. Value Health 15(3):401–403. https://doi.org/10.1016/j.jval.2012.03.1385 CrossRefPubMed

12.

Speight J, Barendse SM (2010) FDA guidance on patient reported outcomes. BMJ 340:c2921. https://doi.org/10.1136/bmj.c2921 CrossRefPubMed

13.

Weaver M, Patrick DL, Markson LE, Martin D, Frederic I, Berger M (1997) Issues in the measurement of satisfaction with treatment. Am J Manag Care 3(4):579–594PubMed

14.

Skogseid IM, Kerty E (2005) The course of cervical dystonia and patient satisfaction with long-term botulinum toxin A treatment. Eur J Neurol 12(3):163–170. https://doi.org/10.1111/j.1468-1331.2004.01053.x CrossRefPubMed

15.

Scott IA, Attia J (2017) Cautionary tales in the interpretation of observational studies of effects of clinical interventions. Intern Med J 47(2):144–157. https://doi.org/10.1111/imj.13167 CrossRefPubMed

16.

International Society for Pharmacoepidemiology (ISPE). Guidelines for Good Pharmacoepidemiological Practices (GPP), June 2015. Accessible at: https://www.pharmacoepi.org/resources/guidelines_08027.cfm

17.

Consky E, Lang AE (1994) Clinical assessments of patients with cervical dystonia. In: Jankovic J, Hallett M (eds) Therapy with botulinum toxin. Marcel Dekker, New York

18.

Tsui JK, Eisen A, Stoessl AJ, Calne S, Calne DB (1986) Double-blind study of botulinum toxin in spasmodic torticollis. Lancet 2(8501):245–247CrossRefPubMed

19.

Hong JS, Sathe GG, Niyonkuru C, Munin MC (2012) Elimination of dysphagia using ultrasound guidance for botulinum toxin injections in cervical dystonia. Muscle Nerve 46(4):535–539. https://doi.org/10.1002/mus.23409 CrossRefPubMed

20.

Truong DMD, Dressler D, Hallett M, Pathak M (eds) (2009) Manual of botulinum toxin therapy. Cambridge University Press, Cambridge

21.

Sethi KD, Rodriguez R, Olayinka B (2012) Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia. J Med Econ 15(3):419–423. https://doi.org/10.3111/13696998.2011.653726 CrossRefPubMed

22.

Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK (2013) Phenomenology and classification of dystonia: a consensus update. Mov Disord 28(7):863–873. https://doi.org/10.1002/mds.25475 CrossRefPubMedPubMedCentral

23.

Defazio G, Conte A, Gigante AF, Fabbrini G, Berardelli A (2015) Is tremor in dystonia a phenotypic feature of dystonia? Neurology 84(10):1053–1059. https://doi.org/10.1212/wnl.0000000000001341 CrossRefPubMed

24.

Trosch R, Espay A, Truong D, Gil R, Singer C, LeWitt PA, Lew MF, Tagliati M, Adler CH, Chen JJ, Marchese D (2017) Comella C (2017) Multicenter observational study of abobotulinumtoxinA neurotoxin in cervical dystonia: The ANCHOR-CD registry. J Neurol Sci 376:84–90. https://doi.org/10.1016/j.jns.2017.02.042 CrossRefPubMed

25.

Jankovic J, Adler CH, Charles D, Comella C, Stacy M, Schwartz M, Manack Adams A, Brin MF (2015) Primary results from the cervical dystonia patient registry for observation of onabotulinumtoxinA efficacy (CD PROBE). J Neurol Sci 349(1–2):84–93. https://doi.org/10.1016/j.jns.2014.12.030 CrossRefPubMed

26.

Fernandez HH, Jankovic J, Holds JB, Lin D, Burns J, Verma A, Sethi K, Pappert EJ (2014) Observational Study of IncobotulinumtoxinA for Cervical Dystonia or Blepharospasm (XCiDaBLE): interim Results for the First 170 Subjects with Blepharospasm. Tremor Other Hyperkinet Mov (N Y) 4:238. https://doi.org/10.7916/d8mk6b1b

Title: INTEREST IN CD2, a global patient-centred study of long-term cervical dystonia treatment with botulinum toxin
Authors: Vijay P. Misra
Carlo Colosimo
David Charles
Tae Mo Chung
Pascal Maisonobe
Savary Om
On behalf of the INTEREST IN CD2 study group
Publication date: 01-02-2018
Publisher: Springer Berlin Heidelberg
Published in: Journal of Neurology / Issue 2/2018
Print ISSN: 0340-5354
Electronic ISSN: 1432-1459
DOI: https://doi.org/10.1007/s00415-017-8698-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 2/2018

Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials

Mutations outside the N-terminal part of RBCK1 may cause polyglucosan body myopathy with immunological dysfunction: expanding the genotype–phenotype spectrum

Eric Heinz Lenneberg (1921–1975)

Clinical and magnetic resonance imaging features of elderly onset dentatorubral–pallidoluysian atrophy

Advances in understanding nociception and neuropathic pain

No need for NMDA receptor antibody screening in neurologically asymptomatic patients with ovarian teratomas