OBJECTIVE
To evaluate effect of long-term BTA treatment on cervical dystonia (CD) symptoms control and patient satisfaction with botulinum therapy in real life setting.
MATERIAL AND METHODS
A total of 1050 patients took part in the international observational study INTEREST IN CD2, the analysis included data from 995 patients (overall population), of which 56 patients were enrolled In Russia. CD clinical assessment was performed at baseline and on the days of BTA injections using the TWSTRS scale and tremor component of the Tsui scale. Patient satisfaction with CD symptoms control was evaluated using 5-point Likert scale on the day of the visit (today satisfaction) and the highest level of satisfaction at any time since the last BTA injection (highest satisfaction). This article presents the results of the analysis of the Russian subgroup of patients in comparison with the overall study population.
RESULTS
In 5 Russian investigational sites, 44 (78.6%) women and 12 (21.4%) men were enrolled in the study; the patients’ mean age was 51.1±9.6 years, the mean duration of the disease was 7.3±5.6 years. The baseline characteristics of the Russian patients were comparable to the overall population, but severity of CD symptoms was numerically higher in the Russian subgroup: the mean TWSTRS severity scores were 17.4±5.0 and 15.9±5.7, respectively; segmental dystonia was observed more frequently (14.3% and 7.4% of patients), as well as shoulder elevation (73.2% and 50.5%) and jerk (21.4% and 9.6%). The vast majority of Russian patients (82.1%) received treatment with abobotulinumtoxin (Dysport). In the Russian subgroup, higher doses of Dysport (median doses 800.0 U and 500.0 U), larger number of targeted muscles (4.3±1.5 and 3.5±1.5) and injection points (11.7±5.5 and 8.1±5.0) were used compared to the overall population. In the Russian subgroup, the mean TWSTRS total score (assessed at the end of each injection cycle) decreased from 32.3±11.2 to 25.2±15.7 over the 3 years follow-up; there was also decrease in severity score from 17.4±5.0 to 12.6±7.5 and disability score from 9.8±4.0 to 7.4±4.8, comparable to the overall population. Patients’ satisfaction with CD symptoms control at peak of the BTA injection effect increased from 92.5% to 98.1% and was higher than in the overall population. At the end of the treatment cycle, patients’ satisfaction was consistently lower than at peak effect.
CONCLUSION
The results of the Russian subgroup analysis showed a high level of long-term effectiveness of botulinum therapy in controlling CD symptoms and patients’ satisfaction with treatment in real clinical practice. Dysport is the most frequently used BTA preparation In Russia, the optimal level of effectiveness with repeated injections of Dysport remains stable and is maintained within the framework of real-life practice, which supports the clinical guidelines recommendations of its use as the drug of choice in the treatment of patients with CD.
