[Safety and efficacy of Relatox in comparison with Dysport in the treatment of focal spasticity of the upper limb in patients after stroke and traumatic brain injury (results of a prospective simple blind randomized comparative study in parallel groups)].

OBJECTIVE

Evaluation of the safety and effectiveness of Relatox, botulinum toxin type A in patients with focal spasticity (FS) of the upper limb as a result of a cerebrovascular accident (CVA) or traumatic brain injury (TBI).

MATERIAL AND METHODS

A multicenter, prospective, single-blinded, randomized, comparative clinical study included 210 patients of both sexes aged 18-75 years after moderate to severe TBI and CVA in seven sites in the Russian Federation. The patients were randomized into two groups. Group 1 patients (=105) with focal spasticity of the upper limb received Relatox injections into the muscles of the target pathological patterns (flexion of the elbow, hand, or fingers); Group 2 patients (=105) received Dysport injections (reference agent). The drugs were injected with electromyographic (EMG) or ultrasound (US) control at a dose of no more than 400 Units of Relatox or 1000 Units of Dysport. Botulinum therapy was administered to patients for the first time or repeatedly, but not earlier than 3 months after CVA or TBI and 3 months (12 weeks) after the previous injection. At 4 and 12 weeks, spasticity was assessed using the Modified Ashworth Scale (MAS) for the muscles of the target spasticity pattern of the upper limb, the severity of disability was used to assess the Disability Assessment Scale (DAS), the severity of pain was evaluated using to the Numerical Pain Rating Scale (NPRS), and the satisfaction with treatment was measured by the Patient Global Impression of Improvement (PGI-I). The rate of adverse events (AEs) was reported.

RESULTS

A decrease in spasticity (decrease in MAS values) was shown in both groups without statistically significant intergroup differences at 4 weeks after injection for the muscles of the leading spasticity pattern of the upper limb (efficacy was assessed jointly for all target patterns) compared to the total score at the screening visit. The effect persisted for 12 weeks (more pronounced in the Relatox group). A significant decrease in pain severity according to the NPRS scale without significant intergroup differences was reported in both groups (slightly greater in Relatox group patients). The decrease in the mean DAS score with a statistically significant intergroup difference in hygiene, dressing, and overall well-being according to the PGI-I overall improvement scale was also greater in patients who received Relatox. Few local and systemic AEs were reported in both groups, with no intergroup differences. There were no significant deviations in laboratory parameters.

CONCLUSION

The results indicate the safety, good tolerability, and efficacy of Relatox in patients with focal spasticity of the upper limb after focal brain damage due to CVA or TBI, comparable and even slightly longer in duration than those of Dysport, which supports its widespread use in the rehabilitation.