An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport)

Abstract

Objectives: It remains to be determined whether the benefits of botulinum toxin type A (BoNT-A) on cervical dystonia (CD) motor symptoms extend to improvements in patient's quality of life (QoL). This analysis of a large, multicentre study was conducted with the aim of investigating changes in QoL and functioning among de novo patients receiving 500 U BoNT-A (abobotulinumtoxinA; Dysport) for the treatment of the two most frequent forms of CD, predominantly torticollis and laterocollis.

Design: A prospective, open-label study of Dysport (500 U; Ipsen Biopharm Ltd) administered according to a defined intramuscular injection algorithm.

Setting: German and Austrian outpatient clinics.

Participants: 516 male and female patients (aged ≥18 years) with de novo CD. The majority of patients had torticollis (78.1%). 35 patients had concomitant depression (MedDRA-defined).

Main outcome measures: Change from baseline to weeks 4 and 12 in Craniocervical Dystonia Questionnaire (CDQ-24) total and subscale scores, patient diary items ('day-to-day capacities and activities', 'pain' and 'duration of pain') and global assessment of pain.

Results: Significant improvements were observed in CDQ-24 total and subscale scores at week 4 and were sustained up to week 12 (p<0.001). Changes in CDQ-24 scores did not significantly differ between the torticollis and laterocollis groups or between patients with or without depression. There were also significant reductions in patient diary item scores for activities of daily living, pain and pain duration at weeks 4 and 12 (p<0.001). Pain relief (less or no pain) was reported by 66% and 74.1% of patients at weeks 4 and 12, respectively. Changes in pain parameters demonstrated a positive relationship with change in Tsui score.

Conclusions: After standardised open-label treatment with Dysport 500 U, improvements in QoL and pain intensity up to 12 weeks in patients with CD were observed.

Figures

Figure 1

Change in Craniocervical Dystonia Questionnaire-24 total and subscale scores from baseline to weeks 4 and 12 (ITT: total population). Total score and all subscores differed significantly from baseline to weeks 4 and 12 (p

Figure 2

Change in patient diary visual analogue score (VAS) from baseline to weeks 4 and 12 (ITT: total population). t Test analysis: p

Figure 3

Time course of change in total Tsui score and total Craniocervical Dystonia Questionnaire-24 (CDQ-24) score. Tsui-score: week 4, n=503 patients; week 12, n=490 patients. CDQ-24: week 4, n=483 patients; week 12, n=473 patients.

Figure 4

Correlation between change in Craniocervical Dystonia Questionnaire-24 total score and change in total Tsui score from baseline to week 4. Display of raw data; one dot may represent more than one patient. Correlation coefficient: 0.26, p