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.

Keywords::

• healthcare costs
• multiple sclerosis
• Spain
• spasticity

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Financial & competing interests disclosure

This study was sponsored by Laboratorios Almirall S.A., Barcelona, Spain. Rafael Arroyo received an honarium from Laboratorios Almirall S.A. as the study coordinator for the 5E study and for contributing to the writing, updating and editing of this article. Carlos Vila is a full-time employee of Laboratorios Almirall S.A., Barcelona, Spain. Steve Clissold is an editorial consultant at Content Ed Net, Madrid, Spain. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. The authors would like to thank Kathy Croom for her assistance with the manuscript, which was provided by ContentEd Net and was funded by Laboratorios Almirall S.A.