The use of IncobotulinumtoxinA in spastic forms of cerebral palsy: a review of randomized clinical trials

Abstract

Botulinum therapy has been used to treat increased muscle tone and spasticity in cerebral palsy (CP) over almost 30 years. Despite this, every year a large number of published scientific articles present new clinical studies devoted to various aspects of the use of botulinum toxin type A (BTA) products in children. The article discusses in detail the results of three major international randomized clinical trials concerning determination the efficacy and safety of the product Xeomin (IncobotulinumtoxinA) in spastic forms of cerebral palsy. All these studies were performed in accordance with the criteria of evidence-based medicine - randomized, prospective, multicenter, comparative, and longitudinal with a large number of patients, clear inclusion and exclusion criteria. The TIM (Treatment with incobotulinumtoxinA in Movement) study demonstrated the effectiveness of the treatment of spasticity of the lower extremities muscles when using different doses of IncobotulinumtoxinA (8, 6 and 2 units/kg of body weight to correct one pathological pattern) in a double-blind study. The TIMO (Treatment with IncobotulinumtoxinA in Movement Open Label) study showed the efficacy and safety of high doses of IncobotulinumtoxinA (total doses of 16-20 units/kg of body weight) in the treatment of spasticity of the lower and upper extremities with prolonged use. The XARA study (IncobotulinumtoxinA in Arm Treatment in Cerebral Palsy) presented data on the high efficacy of IncobotulinumtoxinA when using a multi-level approach for the treatment of lower and upper limb spasticity in CP children and adolescents, which reflects the real clinical needs of a large number of patients. In each of these studies, the safety of the use of IncobotulinumtoxinA was also evaluated. Good tolerability of therapy was demonstrated (84.1% of patients completed all visits in total according to three studies - TIM, TIMO and XARA) and its safety (the frequency of adverse events associated with therapy was observed in less than 2% of cases). Treatment with IncobotulinumtoxinA was characterized by the lack of an immunologic response - Xeomin as a starting therapy provides a stable effect without fading associated with the development of neutralizing antibodies.