Objective: To collect real-world routine clinical practice data on effectiveness, safety, and quality of life (QoL) for botulinum toxin type A (BoNT-A) treatment of focal spasticity.

Background: BoNT-A injections form an important part of the multidisciplinary management of patients with spasticity, but long-term data from real-world practice are limited.

Methods: SPACE was an international, observational study that followed BoNT-A-naïve adults with spasticity for ≤2 years. Patients received any BoNT-A formulation available in their country according to a treatment regimen (doses, dilutions, injection sites, treatment intervals) at the discretion of their physician. Treatment goals, injection techniques, doses used, muscles treated, QoL (EQ-5D questionnaire), and adverse drug reactions (ADRs) were documented.

Results: Overall, 687 patients (61.3% male) with spasticity (mean duration 5.4 years) mainly because of stroke (64.6%) or multiple sclerosis (9.3%) from nine countries participated. At baseline, the most common spasticity patterns were flexed elbow (58.1%) and flexed wrist (50.9%) in the upper limbs, and equinovarus (32.2%) and extended knee (21.0%) in the lower limbs. The most frequently treated muscles in the upper limbs were flexor digitorum superficialis and biceps brachialis, and gastrocnemius medial and soleus in the lower limbs. The most commonly used guidance technique was electrostimulation (18.5%), but many injections (40.2%) were given without guidance. Considerable differences between countries were observed. Improvements in limb function (mobility and/or dexterity) and pain relief were the most frequent treatment goals. QoL improved over the study duration. Sixteen (2.7%) patients had an ADR (of 600 patients with collection of ADRs). The majority of participating physicians (101/171, 59.1%) would have favored the injection of higher BoNT-A doses if labeling restrictions were absent.

Conclusions: SPACE confirmed the good tolerability of BoNT-A formulations. Many physicians would prefer to inject higher total BoNT-A doses to enable the treatment of more spasticity patterns in patients with complex multifocal spasticity. Further clinical studies are required to explore the safety and efficacy of higher doses than those currently generally used.

2nd European Academy of Neurology Congress, May 28-31, 2016 (in part).

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MDS Abstracts - https://www.mdsabstracts.org/abstract/spasticity-in-practice-space-an-international-observational-study-of-botulinum-toxin-type-a-in-spasticity/