IMPORTANT NOTICE :

Dear BELTRIMS user,

Unfortunately, the company hosting BELTRIMS has decided to go to another line of business as of September 30th. Until we can transfer the data to another host, it will not be possible to enter data in the BELTRIMS Registry or to access or make changes to the existing data.

We will inform you as soon as the problem is solved. In the meantime, we encourage you to keep the data on paper (Variables overview_BELTRIMS-011021 available on request to info@bsgms.org). Once the registry is operational again, assistance will be provided to enter the data to catch up with the delay.

More information about this problem will be provided during the General Assembly of November 30th.

We apologize for the inconvenience.

Bénédicte Dubois, President BSGMS

 

BELTRIMS

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 contact Mrs. Isabelle Bloem: isabelle.bloem@bsgms.org

Dr. Barbara Willekens
Dr. Pierrette Seeldrayers
Belgian Study Group for Multiple Sclerosis