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

the INTEREST IN CD2 study group

doi:10.1007/s00415-019-09527-2

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

the INTEREST IN CD2 study group

Bar-Ilan University - Azrieli Faculty of Medicine

Santa Maria University Hospital
Vanderbilt University
Imperial College Healthcare NHS Trust
Ipsen

Research output: Contribution to journal › Article › peer-review

28 Scopus citations

Abstract

Background: Patients 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. Methods: This 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. Results: Subject 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. Conclusions: Despite 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.

Original language	English
Pages (from-to)	3038-3046
Number of pages	9
Journal	Journal of Neurology
Volume	266
Issue number	12
DOIs	https://doi.org/10.1007/s00415-019-09527-2
State	Published - 1 Dec 2019

Bibliographical note

Publisher Copyright:
© 2019, The Author(s).

Funding

The INTEREST IN CD2 study is sponsored by Ipsen Pharma. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. The authors wish to thank all participating sites, principal investigators, sub-investigators, study coordinators and patients who contributed to the INTEREST IN CD2 study. We thank Anita Chadha-Patel PhD of ACP Clinical Communications Ltd (Hertfordshire, UK) for providing medical writing support, which was funded by Ipsen (Paris, France) in accordance with Good Publication Practice guidelines. The INTEREST IN CD2 study is sponsored by Ipsen Pharma. We confirm that we have read the Journal?s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. The authors wish to thank all participating sites, principal investigators, sub-investigators, study coordinators and patients who contributed to the INTEREST IN CD2 study. We thank Anita Chadha-Patel PhD of ACP Clinical Communications Ltd (Hertfordshire, UK) for providing medical writing support, which was funded by Ipsen (Paris, France) in accordance with Good Publication Practice guidelines. The members of the INTEREST IN CD2 study group: Abdulnayef A, Adatepe NU, Araujo Leite MA, Badarny S, Bajenaru O, Bares M, Bejjani P, Bergmans B, Bhidayasiri R, Bozic H, Cardoso Costa FE, Carlstrom C, Castelnovo G, Chang MH, Chang YY, Chung TM, Coletti-Moja M, Delvaux V, Dioszhegy P, Dogu O, Duzynski W, Ehler E, Espinosa Sierra L, Fabbrini G, Ferreira J, Ferreira Valadas A, Foresti C, Girlanda P, Goh KJ, Graca Velon A, Grill S, Gurevitch T, Hadidi M, Hamimed MA, Hamri A, Harrower T, Hassin S, Hedera P, Hernandez JFJG, Hernandez Franco J, Ho B, Ho SL, Hughes A, Ilic T, Inshasi JS, Ip CW, Jamieson S, Jamora RDG, Jech R, Jeon BS, Kaminska A, Karpova M, Khasanova D, Kim JM, Kim JW, Kok CY, Korenko A, Korv J, Koussa S, Kovacs T, Kreisler A, Krystkowiak P, Kumthornthip W, Lin CH, Lundin F, Lus G, Magalhaes M, Masmoudi AN, Mercelis R, Misbahuddin A, Moebius C, Mohammadi B, Nazem B, Ng K, Nurlu G, Nyberg J, Nyholm D, Ochudlo S, Otruba P, Pfister R, Pirtosek Z, Pokhabov D, Quinones Aguilar S, Quinones Canales G, Raghev S, Rickmann H, Romano M, Rosales RL, Rubanovits I, Santilli V, Schoels L, Simonetta-Moreau M, Simu MA, Sohn YH, Soulayrol S, Supe I, Svetel M, Sycha T, Tan EK, Timerbaeva S, Tokcaer AB, Trosch R, Tugnoli V, Tumas V, Van der Linden C, Vetra A, Vial C, Vidry E, Williams D, Wimalaratna S, Yiannikas C. This study was sponsored by Ipsen Pharma.

Funders
Chang MH
Chang YY
Chung TM
Ipsen Pharma
Ipsen Biopharmaceuticals
Ipsen

Keywords

Botulinum toxin
Cervical dystonia
Observational study
Satisfaction
Treatment

Access to Document

10.1007/s00415-019-09527-2

Cite this

@article{81b93930d16442cab145901ff8891d0b,

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

abstract = "Background: Patients 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. Methods: This 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. Results: Subject 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. Conclusions: Despite 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.",

keywords = "Botulinum toxin, Cervical dystonia, Observational study, Satisfaction, Treatment",

author = "\{the INTEREST IN CD2 study group\} and Carlo Colosimo and David Charles and Misra, \{Vijay P.\} and Pascal Maisonobe and Savary Om and A. Abdulnayef and Adatepe, \{N. U.\} and \{Araujo Leite\}, \{M. A.\} and S. Badarny and O. Bajenaru and M. Bares and P. Bejjani and B. Bergmans and R. Bhidayasiri and H. Bozic and Cardoso Costa, \{F. E.\} and C. Carlstrom and G. Castelnovo and Chang, \{M. H.\} and Chang, \{Y. Y.\} and Chung, \{T. M.\} and M. Coletti-Moja and V. Delvaux and P. Dioszhegy and O. Dogu and W. Duzynski and E. Ehler and \{Espinosa Sierra\}, L. and G. Fabbrini and J. Ferreira and \{Ferreira Valadas\}, A. and C. Foresti and P. Girlanda and Goh, \{K. J.\} and \{Graca Velon\}, A. and S. Grill and T. Gurevitch and M. Hadidi and Hamimed, \{M. A.\} and A. Hamri and T. Harrower and S. Hassin and P. Hedera and Hernandez, \{J. F.J.G.\} and \{Hernandez Franco\}, J. and B. Ho and Ho, \{S. L.\} and A. Hughes and T. Ilic and Inshasi, \{J. S.\}",

note = "Publisher Copyright: {\textcopyright} 2019, The Author(s).",

year = "2019",

month = dec,

day = "1",

doi = "10.1007/s00415-019-09527-2",

language = "אנגלית",

volume = "266",

pages = "3038--3046",

journal = "Journal of Neurology",

issn = "0340-5354",

publisher = "Springer Science and Business Media Deutschland GmbH",

number = "12",

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TY - JOUR

T1 - How satisfied are cervical dystonia patients after 3 years of botulinum toxin type A treatment? Results from a prospective, long-term observational study

AU - the INTEREST IN CD2 study group

AU - Colosimo, Carlo

AU - Charles, David

AU - Misra, Vijay P.

AU - Maisonobe, Pascal

AU - Om, Savary

AU - Abdulnayef, A.

AU - Adatepe, N. U.

AU - Araujo Leite, M. A.

AU - Badarny, S.

AU - Bajenaru, O.

AU - Bares, M.

AU - Bejjani, P.

AU - Bergmans, B.

AU - Bhidayasiri, R.

AU - Bozic, H.

AU - Cardoso Costa, F. E.

AU - Carlstrom, C.

AU - Castelnovo, G.

AU - Chang, M. H.

AU - Chang, Y. Y.

AU - Chung, T. M.

AU - Coletti-Moja, M.

AU - Delvaux, V.

AU - Dioszhegy, P.

AU - Dogu, O.

AU - Duzynski, W.

AU - Ehler, E.

AU - Espinosa Sierra, L.

AU - Fabbrini, G.

AU - Ferreira, J.

AU - Ferreira Valadas, A.

AU - Foresti, C.

AU - Girlanda, P.

AU - Goh, K. J.

AU - Graca Velon, A.

AU - Grill, S.

AU - Gurevitch, T.

AU - Hadidi, M.

AU - Hamimed, M. A.

AU - Hamri, A.

AU - Harrower, T.

AU - Hassin, S.

AU - Hedera, P.

AU - Hernandez, J. F.J.G.

AU - Hernandez Franco, J.

AU - Ho, B.

AU - Ho, S. L.

AU - Hughes, A.

AU - Ilic, T.

AU - Inshasi, J. S.

PY - 2019/12/1

Y1 - 2019/12/1

N2 - Background: Patients 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. Methods: This 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. Results: Subject 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. Conclusions: Despite 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.

AB - Background: Patients 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. Methods: This 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. Results: Subject 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. Conclusions: Despite 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.

KW - Botulinum toxin

KW - Cervical dystonia

KW - Observational study

KW - Satisfaction

KW - Treatment

UR - https://www.scopus.com/pages/publications/85073956360

U2 - 10.1007/s00415-019-09527-2

DO - 10.1007/s00415-019-09527-2

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C2 - 31501975

AN - SCOPUS:85073956360

SN - 0340-5354

VL - 266

SP - 3038

EP - 3046

JO - Journal of Neurology

JF - Journal of Neurology

IS - 12

ER -