Demographic and clinical factors associated with continued Sativex treatment after one year

Abstract

Multiple sclerosis (MS) is an autoimmune disease that targets the central nervous system. To date, the cause of MS remains unclear. The cause is probably a combination of genetic and environmental factors. There are different subtypes of MS, namely: RRMS, SPMS and PPMS. One of the most common symptoms of progressive MS is spasticity. This spasticity is mainly treated with physical therapy and common drugs, such as oral baclofen. However, not everyone experiences a good effect. The next option is treatment with Sativex®. However, it is important to note that not just anyone can start treatment with Sativex®. Only patients with moderate to severe spasticity who have not responded adequately to other anti-spasticity medication may start treatment after thorough screening.If the patient meets the necessary conditions, it is not yet certain that he/she will benefit sufficiently from this treatment. Therefore, it would be helpful if certain clinical or demographic factors could predict whether a patient will continue treatment with Sativex® after one year.
These clinical/demographic factors include tools (age, gender, subtype MS, SDMT, NRS, VAS and EDSS), the use of other medications and the reduction of the NRS score during the trial treatment period. For all these factors, a statistical analysis performed in SPSS will examine whether there is a significant difference between the group that continues treatment after one year and
the group that stops treatment before one year is reached. For all the different tools, no significant difference was found between the two groups. There is
a strong possibility that the study population is too small and not sufficiently representative. For example, one can already see from the ratio of men to women that it is different than is generally assumed for people with MS.
Also, the taking of other medication does not cause a significant difference between both groups.
The p-value for the group of hypolipemic drugs is close to the limit of significance, so perhaps when this study is repeated with a more extensive study population, a significant difference can be observed.
Finally, a significant difference was observed between the group that continued treatment after one year and the group that stopped treatment before one year was reached, for the reduction of the NRS score. For this purpose, the reduction in NRS score during the first four weeks of the trial treatment period was used. It can be concluded that the greater the reduction in NRS score, the greater the chance that the patient will continue treatment with Sativex® after one year.
In conclusion, apart from the reduction in NRS score, there are no clinical or demographic factors that can predict whether a patient will continue to use Sativex® to treat spasticity after one year.

Date of Award	9 Jun 2021
Original language	English
Sponsors	National MS Center Melsbroek