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BELTRIMS: Belgian national register for the treatment of MS

Several new treatments have been introduced in recent years to treat multiple sclerosis (MS). These treatments each have different mechanisms of action and variable side effects and require strict individualised monitoring. Their medium- and long-term effectiveness and side effects are, however, unknown. 
The BELTRIMS register (Belgian Treatments in Multiple Sclerosis) was established by the “Groupe belge d’étude de la sclérose en plaques (GBESP)”. Its purpose is to prospectively collect the follow-up data for new MS treatments.
By April 2017, 72 neurologists, members of the GBESP, had entered 1041 patients into the register. The treatments entered most often were, in decreasing order: Gilenya® (279), Aubagio® (266), Tecfidera® (240) and Tysabri® (117). 
 
Aubagio®
  • 79% of patients initiated treatment with Aubagio® because of side effects, contraindications or injection intolerance to interferons or glatiramer acetate. 27% also had an increase in the number of lesions documented through brain imaging.
  • The monitoring data shows that the treatment was followed satisfactorily in 92 to 96% of cases between 6 and 24 months after having started on Aubagio®. During this time period, between 6 and 11% of patients had an exacerbation and the percentage of patients that showed a progression of disability was between 3 and 4.5%.
  • The rate at which treatment was spontaneously stopped was between 2 and 4.6%. Roughly 30% of patients showed an increase in the number of lesions seen on brain MRIs, with active lesions in 21 to 28.6% of cases. In the all group, the treatment was stopped in 7 to 8.6% of cases.
  • The side effects reported match Aubagio®’s known profile.
Tecfidera®
  • 53% of patients initiated treatment with Tecfidera® because of side effects, contraindications or injection intolerance to interferons or glatiramer acetate. 29% had had an exacerbation before initiating this treatment. 43% also had an increase in the number of lesions documented through brain imaging.
  • Once again, the treatment was found to be followed satisfactorily in 86 to 91% of cases, between 6 and 24 months after having started on Tecfidera®. During this time period, between 5 and 7% of patients had an exacerbation. The percentage of patients that showed a progression of disability was between 0.7 and 2.5%.
  • The rate at which treatment was spontaneously stopped was between 1.6 and 3.6%. About 17 and 22% of patients showed an increase in the number of lesions seen on brain MRIs, with active lesions in 9 to 18% of cases. In all, these results led to the treatment being stopped in 5.6 to 7% of cases.
  • The side effects reported match Tecfidera®’s known profile.
Gilenya®
  • Among the patients that began a treatment with Gilenya®, 71% had had an exacerbation during first line treatment, 17% had first been treated with Tysabri® and 12% initiated this as their first treatment. 47% also had an increase in the number of lesions documented through brain imaging.
  • The treatment was followed satisfactorily in 96 to 99% of cases, between 6 and 24 months after having started on Gilenya®. During this time period, between 2 and 6% of patients had an exacerbation. The percentage of patients that showed a progression of disability was between 4 and 6%.
  • The rate at which treatment was spontaneously stopped was between 1.6 and 1%. At 6 months of treatment, 25% of patients showed an increase in the number of lesions seen on brain MRIs. However, this percentage dropped to 10-17% between 12 and 24 months of treatment. During this time, “active” lesions were identified in 10 to 23.5% of cases. In all, these results led to the treatment being stopped in fewer than 2% of cases.
  • The side effects reported match Gilenya®’s known profile.

 

In conclusion, the BELTRIMS register, with the support of the Belgian Charcot Foundation, is a unique national initiative which enables the medium- and long-term analysis of the effectiveness and side effects of new MS treatments. Numerous data still need to be analysed. The GBESP plans to use these data for scientific purposes at conventions and in publications. As a result of the unique pharmacovigilance data being introduced, BELTRIMS is complementary with other existing MS registers such as EDMUS and MSBase. One of the challenges facing BELTRIMS will be to encourage participating neurologists to continue entering follow-up data into the register over the long-term.

Prof. Vincent van Pesch, Cliniques Universitaires Saint-Luc

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