The Danish Multiple Sclerosis Treatment Register

Abstract

Aim of the database

The Danish Multiple Sclerosis Treatment Register (DMSTR) serves as a clinical quality register, enabling the health authorities to monitor the quality of the disease-modifying treatment, and it is an important data source for epidemiological research.

Study population

The DMSTR includes all patients with multiple sclerosis who had been treated with disease-modifying drugs since 1996. At present, more than 8,400 patients have been registered in this database. Data are continuously entered online into a central database from all sites in Denmark at start and at regular visits.

Main variables

Include age, sex, onset year and year of the diagnosis, basic clinical information, and information about treatment, side effects, and relapses.

Descriptive data

Notification is done at treatment start, and thereafter at every scheduled clinical visit 3 months after treatment start, and thereafter every 6 months. The longitudinally collected information about the disease activity and side effects made it possible to investigate the clinical efficacy and adverse events of different disease-modifying therapies.

Conclusion

The database contributed to a certain harmonization of treatment procedures in Denmark and will continue to be a major factor in terms of quality in clinical praxis, research and monitoring of adverse events, and plays an important role in research.

Keywords:

• multiple sclerosis
• epidemiology
• immunomodulatory treatment
• neutralizing antibodies
• observational studies
• registry research
• disease modifying therapy

Acknowledgments

This paper was funded by the Program for Clinical Research Infrastructure (PROCRIN), established by the Lundbeck Foundation and the Novo Nordisk Foundation and administered by the Danish Regions.

Disclosure

MM has served on scientific advisory board for Biogen Idec and Teva Pharmaceutical Industries Ltd.; has received honoraria for lecturing from Biogen Idec, Merck Serono, Novartis, Teva Pharmaceutical Industries Ltd.; has received support for congress participation from Biogen Idec, Teva Pharmaceutical Industries Ltd., Genzyme, and Novartis. NK-H has received honoraria for lecturing and participation in advisory councils, travel expenses for attending congresses and meetings from Bayer Schering Pharma AG, Merck Serono, Biogen Idec, Teva Pharmaceutical Industries Ltd., Sanofi-Aventis, and Novartis. PSS has served on scientific advisory boards for Biogen Idec, Merck Serono, Novartis, Genzyme, Teva Pharmaceutical Industries Ltd., GlaxoSmithKline, MedDay Pharmaceuticals, and Forward Pharma; has been on steering committees or independent data monitoring boards in clinical trials sponsored by Merck Serono, Teva Pharmaceutical Industries Ltd., and GlaxoSmithKline; and has received speaker honoraria from Biogen Idec, Merck Serono, Teva Pharmaceutical Industries Ltd., Genzyme, and Novartis. His department has received research support from Biogen Idec, Bayer Schering, Merck Serono, Teva Pharmaceutical Industries Ltd., Baxter, Sanofi-Aventis, BioMS, Novartis, Bayer, RoFAR, Roche, Genzyme, from the Danish Multiple Sclerosis Society, the Danish Medical Research Council, and the European Union Sixth Framework Programme: Life sciences, Genomics and Biotechnology for health. The authors report no other conflicts of interest in this work.