Retrospective observational study of the management of multiple sclerosis patients with resistant spasticity in Spain: the '5E' study

Abstract

Background: Multiple sclerosis spasticity (MSS) is a common and disabling symptom for which a number of antispastic agents are available; however, evidence-based guidelines for optimal management are lacking.

Objective: This retrospective observational assessment investigated the current management approach for resistant MSS in Spain. Secondary objectives were to evaluate the evolution of MSS and to estimate the social and health-related costs of managing MSS in the Spanish healthcare system.

Methods: A retrospective analysis was performed using case records from 212 MS patients with spasticity that were resistant to ≥ 1 previous therapy. Data were collected over 1-3 years (mean 2.1 years), including: sociodemographics, medical history, clinical scores and all therapy/other resources consumed (e.g., rehabilitation and carers' time). Disease progression was estimated from the evolution of recorded clinical scales, and an analysis of costs from a Spanish healthcare and social perspective was performed.

Results: The majority of patients were female and most had secondary progressive MS. Baclofen (76-80%), tizanidine and benzodiazepines were the most common antispastic drugs administered. A variety of spasticity rating scales were employed, and they demonstrated the same general trends. MS progressed, with the composite score for spasticity and mobility deteriorating in 46.4% of patients, and there were no marked differences between antispasticity drugs. The annual healthcare-related cost of treating an MSS resistant patient in the Spanish healthcare system was €15,405, largely attributable to the cost of disease-modifying drugs and care provision. Other aspects, such as medical visits and antispastic treatments, formed only a small portion of cost.

Conclusions: MSS progresses despite treatment with currently available antispastic agents, and it is associated with a high level of disability. Spasticity treatment represents a minor element of the overall cost of managing MSS patients in Spain. The approach to the assessment of spasticity varies between centers.