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Observational Study
. 2018 Feb;265(2):402-409.
doi: 10.1007/s00415-017-8698-2. Epub 2017 Dec 21.

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

Vijay P Misra  1 , Carlo Colosimo  2 , David Charles  3 , Tae Mo Chung  4 , Pascal Maisonobe  5 , Savary Om  5 ; INTEREST IN CD2 study group
Collaborators, Affiliations
Observational Study

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

Vijay P Misra et al. J Neurol. 2018 Feb.

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.

Keywords: Botulinum toxin; Cervical dystonia; Observational study; Tremor.

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Conflict of interest statement

Conflicts of interest

Dr VP Misra, Prof C Colosimo, Dr D Charles and Dr TM Chung formed the INTEREST IN CD2 steering committee and report consultancy for Ipsen. Mr P Maisonobe and Dr S Om are Ipsen employees.

Ethical standards

This study complied with the International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP). Independent Ethics Committee/Institutional Review Board approval was obtained prior to each centre initiation. Informed consent was obtained prior to subject enrolment and prior to any data collection.

Figures

Fig. 1
Fig. 1
Subject satisfaction with BoNT-A treatment in BoNT previously treated subjects at baseline. *Missing data in one subject from the 12–16 weeks population. **Injection interval between last BoNT injection prior to study entry and baseline visit was unknown in four subjects, however, the satisfaction rating was available for them. BoNT botulinum neurotoxin, BoNT-A botulinum neurotoxin type A
See this image and copyright information in PMC

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