Patient Characteristics and Treatment Patterns

In the second study, RRMS patients from five European MS registries that had already participated in the first study were re-examined using the previously defined characteristics.

This study compared characteristics of MS patients from five MS registries who had been clinically classified as having RRMS and who could potentially be classified as having SPMS using the algorithm-based classification methods (from study 1).

Data from MS registers in Denmark (10,255 patients), Germany (23,185 patients), the UK (5,086 patients), Sweden (11,247 patients) and the Czech Republic (11,336 patients) were used. Patients were included if they had been diagnosed with RRMS or SPMS and were at least 18 years old at the start of the study. In addition to the clinical classification of SPMS, the data-based classification method, the Decision tree classifier of the Karolinska Institute, was applied based on age and (last) EDSS.

As a result of the study, it was found that clinical RRMS patients could be reclassified as SPMS in all MS registries. Using the decision tree classifier, a total of 8,372 RRMS patients were reclassified as SPMS in the five registries, increasing the overall proportion of SPMS patients from 17% to 31%. The overall proportion of clinically identified SPMS patients receiving disease-modifying therapy (DMT) was 36%, but varied widely between registries. The overall proportion of reclassified SPMS patients receiving DMT was significantly higher at 69%.

The study concludes that SPMS patients receiving a DMT are often clinically misclassified as RRMS patients. This raises the question of whether the time from MS onset to transition to the secondary progressive form of MS should be used as a measure of the efficacy of DMTs and argues for the use of objective classification methods when analyzing MS patient populations.

A real-world evaluation of multifaceted aspects of progressive MS

The third study examined adult MS patients from nine different MS registries who were in their secondary progressive phase of MS. In addition to demographic and clinical characteristics, disability progression was also considered and assessed in relation to prescribed disease-modifying therapies.

The study looked at data from MS patients over a two-year period (January 1, 2015 to January 1, 2017) who were classified as having SPMS up to January 1, 2015. These patients were divided into two groups and their data compared:

- MS patients who received disease-modifying therapies at least 80% of the time during the two-year period and at the end of the two years, 

- MS patients who received no disease-modifying therapies less than 20% of the time during the two-year period and at the end of the two years.

In addition, in a subsequent one-year period (from January 1, 2017 to January 1, 2021), EDSS scores were used to examine how the course of disability developed. 

The registries differed greatly in the number of patients who met the inclusion criteria of the study (Denmark = 534; Sweden = 1293; Czech Republic = 718; United Kingdom = 15; Germany = 279; Italy = 2337; Finland = 104; France = 3236; MSBase - International = 1722).

The results show that untreated SPMS patients were older at the end of the first study period (January 1, 2017) and at the time of SPMS diagnosis and had experienced a longer period of illness. At the same time, the results showed that untreated SPMS patients had a higher EDSS on average at the end of the first study period, but fewer relapses. The average increase in EDSS in the group of untreated SPMS patients differed in the various data sources.

The data generally indicate that there is a positive effect of disease-modifying therapies in slowing disease development at an earlier stage of the progressive phase. However, it also shows that in older patients, continued treatment with disease-modifying therapies does not necessarily have the same slowing effect on the progression of EDSS.