Contributions
Abstract: EP1629
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: In 2012, a working group from the Belgian Study Group for Multiple Sclerosis (BSGMS) created the first Belgian registry of multiple sclerosis (MS) patients, who starting a new disease modifying treatment (DMT). No such registry existed in Belgium yet.
Objectives: To describe real-world side-effects and efficacy data based on data extracted from a prospective registry of Belgian MS patients. To compare these data to existing literature. To continuously add data to this registry.
Aims: We aim to collect data independent from pharmaceutical companies in a single registry, as opposed to having different registries for each new DMT. In doing so, we anticipate to detect unknown or rare side-effects, to collect real-life efficacy data and to capture pregnancy outcomes.
Methods: Neurologists who are members of the BSGMS can enter patients after approval of the BELTRIMS registry protocol by local and central ethics committee and obtaining informed consent from each patient. An electronic CRF was developed, with forms for starting a treatment, patient history, adverse events and serious adverse events. 6 monthly follow-up forms contain clinical status including relapses and EDSS, as well as standard MRI data. The registry is owned and managed by the BSGMS, with support of Custodix NV.
Results: As of April 1st 2018, 1375 patients have been registered by 42 centers. 286 Patients are treated with fingolimod, 265 with dimethylfumarate, 253 with teriflunomide, 139 with natalizumab, 78 with injectable first line treatment, 42 with alemtuzumab. 45 patients are untreated while 5 received other treatments. Data cleaning is ongoing. Final results will be presented during ECTRIMS.
Conclusions: We describe here the first analysis of data from the BELTRIMS registry. Adverse events, serious adverse events and real-world efficacy will be discussed.
Disclosure: Funding source: This registry is supported by a grant from the Belgian Charcot Foundation. Disclosures: Barbara Willekens received travel support for attending meetings from Biogen, Merck Serono, Genzyme, Roche, TEVA, Novartis. The institution of Barbara Willekens received research support and grants from Sanofi-Genzyme, Roche, Merck_serono, Novartis and speaker and consultancy honoraria from Roche, Biogen, Merck, Novartis, Sanofi-Genzyme, TEVA.
Abstract: EP1629
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: In 2012, a working group from the Belgian Study Group for Multiple Sclerosis (BSGMS) created the first Belgian registry of multiple sclerosis (MS) patients, who starting a new disease modifying treatment (DMT). No such registry existed in Belgium yet.
Objectives: To describe real-world side-effects and efficacy data based on data extracted from a prospective registry of Belgian MS patients. To compare these data to existing literature. To continuously add data to this registry.
Aims: We aim to collect data independent from pharmaceutical companies in a single registry, as opposed to having different registries for each new DMT. In doing so, we anticipate to detect unknown or rare side-effects, to collect real-life efficacy data and to capture pregnancy outcomes.
Methods: Neurologists who are members of the BSGMS can enter patients after approval of the BELTRIMS registry protocol by local and central ethics committee and obtaining informed consent from each patient. An electronic CRF was developed, with forms for starting a treatment, patient history, adverse events and serious adverse events. 6 monthly follow-up forms contain clinical status including relapses and EDSS, as well as standard MRI data. The registry is owned and managed by the BSGMS, with support of Custodix NV.
Results: As of April 1st 2018, 1375 patients have been registered by 42 centers. 286 Patients are treated with fingolimod, 265 with dimethylfumarate, 253 with teriflunomide, 139 with natalizumab, 78 with injectable first line treatment, 42 with alemtuzumab. 45 patients are untreated while 5 received other treatments. Data cleaning is ongoing. Final results will be presented during ECTRIMS.
Conclusions: We describe here the first analysis of data from the BELTRIMS registry. Adverse events, serious adverse events and real-world efficacy will be discussed.
Disclosure: Funding source: This registry is supported by a grant from the Belgian Charcot Foundation. Disclosures: Barbara Willekens received travel support for attending meetings from Biogen, Merck Serono, Genzyme, Roche, TEVA, Novartis. The institution of Barbara Willekens received research support and grants from Sanofi-Genzyme, Roche, Merck_serono, Novartis and speaker and consultancy honoraria from Roche, Biogen, Merck, Novartis, Sanofi-Genzyme, TEVA.