The BELTRIMS registry
In 2012, a working group from the Belgian Study Group for Multiple Sclerosis, under the lead of Dr. Pierrette Seeldrayers and with the support of Dr. Barbara Willekens, started a Belgian registry of Multiple Sclerosis (MS) patients who are starting new treatment. There had previously been no such registry; follow-up of side-effects after the introduction on the market of new MS treatments was done by pharmaceutical companies, thus making long term follow up of patients almost impossible.
The working group took advantage of the fact that prescription of Gilenya® (fingolimod) had been limited to so-called « MS experts », almost all members of the BSGMS, to create a registry of Belgian patients treated with Fingolimod. This was the BELFIMS registry, a first step in establishing a national registry of Belgian MS patients. The ultimate goal of this registry was to detect unknown or rare side-effects, to capture pregnancy outcomes (although pregnancy is contra-indicated while taking this drug), and to collect real-life efficacy data. As Aubagio® (teriflunomide) became available in the context of a medical need program in 2013 and Tecfidera® (dimethylfumarate) was added to the therapeutic arsenal in 2014, it was decided to enlarge the registry to include patients starting any new MS drug. Thus, BELFIMS became BELTRIMS.
In January 2014, the Belgian Treatment in Multiple Sclerosis, or BELTRIMS registry, was approved by the Central Ethics Committee of Antwerp University Hospital.
As stated earlier, the great advantage of this registry is that data are collected independently in a single registry. It thus became possible to follow the long term effect of treatment on disease evolution independently of eventual change from one immunosuppressive or immunomodulatory drug to another, as well as to collect data on short- and long-term side-effects, with special attention to infections and malignancies. Follow-up data is captured every 6 months after the initial evaluation and serious side-effects are recorded. It is important to note that we only register data that are available from routine clinical practice (e.g., number of relapses, MRI number of T2 or enhancing lesions, lab results, EDSS); no extra investigations are done for this registry.
Any new disease modifying drug that appears on the market is entered into the registry.
At present, there are 43 participating centers and more than 2100 patients in the registry. Any participating center can send a request for analysis that will be evaluated by the working group. Posters and publications are planned as well as regular diffusion of information concerning any serious adverse events entered into the registry.
We hope that all neurologists who are members of the BSGMS will participate in this registry, and that as many patients as possible will be included, as this could fill an important gap in our knowledge of MS treatment.
If you are interested, please send your request to : info@bsgms.org
Prof. Bénédicte Dubois
Belgian Study Group for Multiple Sclerosis
