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Original research
Prognostic factors for disease activity in newly diagnosed teriflunomide-treated patients with multiple sclerosis: a nationwide Danish study
  1. Mie Reith Mahler1,
  2. Melinda Magyari1,2,
  3. Luigi Pontieri1,
  4. Frederik Elberling1,
  5. Rolf Pringler Holm1,
  6. Arkadiusz Weglewski2,3,
  7. Mai Bang Poulsen4,
  8. Lars Kristian Storr5,
  9. Plamen Anzhelov Bekyarov6,
  10. Zsolt Illes7,
  11. Matthias Kant8,
  12. Tobias Sejbaek9,10,
  13. Morten Leif Stilund11,
  14. Peter V Rasmussen12,
  15. Maria Brask13,
  16. Inga Urbonaviciute14,
  17. Finn Sellebjerg1,2
  1. 1The Danish Multiple Sclerosis Registry, Danish Multiple Sclerosis Research Center, Copenhagen University Hospital, Glostrup, Denmark
  2. 2Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
  3. 3Department of Neurology, Herlev Hospital, Herlev, Denmark
  4. 4Department of Neurology, Nordsjaellands Hospital, Hilleroed, Denmark
  5. 5Department of Neurology, Zealand University Hospital, Roskilde, Denmark
  6. 6Department of Neurology, Slagelse Hospital, Slagelse, Denmark
  7. 7Department of Neurology, Odense University Hospital, Odense, Denmark
  8. 8Department of Neurology, Hospital of Southern Jutland Soenderborg Branch, Soenderborg, Denmark
  9. 9Department of Neurology, Esbjerg Central Hospital, Esbjerg, Denmark
  10. 10Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
  11. 11Department of Neurology, Physiotherapy and Occupational Therapy, Goedstrup Hospital, Herning, Denmark
  12. 12Department of Neurology, Aarhus University Hospital, Aarhus, Denmark
  13. 13Department of Neurology, Viborg Regional Hospital, Viborg, Denmark
  14. 14Department of Neurology, Aalborg University Hospital, Aalborg, Denmark
  1. Correspondence to Mie Reith Mahler, The Danish Multiple Sclerosis Registry, Copenhagen University Hospital Danish Multiple Sclerosis Research Center, Glostrup 2600, Denmark; mie.mahler{at}dadlnet.dk

Abstract

Background Clinicians frequently rely on relapse counts, T2 MRI lesion load (T2L) and Expanded Disability Status Scale (EDSS) scores to guide treatment decisions for individuals diagnosed with multiple sclerosis (MS). This study evaluates how these factors, along with age and sex, influence prognosis during treatment with teriflunomide (TFL).

Methods We conducted a nationwide cohort study using data from the Danish Multiple Sclerosis Registry.

Eligible participants had relapsing-remitting MS or clinically isolated syndrome and initiated TFL as their first treatment between 2013 and 2019. The effect of age, pretreatment relapses, T2L and EDSS scores on the risk of disease activity on TFL were stratified by sex.

Results In total, 784 individuals were included (57.4% females). A high number of pretreatment relapses (≥2) was associated with an increased risk of disease activity in females only (OR and (95% CI): 1.76 (1.11 to 2.81)). Age group 50+ was associated with a lower risk of disease activity in both sexes (OR females=0.28 (0.14 to 0.56); OR males=0.22 (0.09 to 0.55)), while age 35–49 showed a different impact in males and females (OR females=0.79 (0.50 to 1.23); OR males=0.42 (0.24 to 0.72)). EDSS scores and T2L did not show any consistent associations.

Conclusion A high number of pretreatment relapses was only associated with an increased risk of disease activity in females, while age had a differential impact on the risk of disease activity according to sex. Clinicians may consider age, sex and relapses when deciding on TFL treatment.

  • MULTIPLE SCLEROSIS
  • EVIDENCE-BASED NEUROLOGY
  • NEUROEPIDEMIOLOGY
  • ORAL MEDICINE
  • STATISTICS

Data availability statement

Data are available upon reasonable request. Access to data is possible through a qualified request approved by the Capital Region of Denmark.

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Data availability statement

Data are available upon reasonable request. Access to data is possible through a qualified request approved by the Capital Region of Denmark.

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Footnotes

  • Contributors Concept and design: MRM, FS, MM, LP, RPH and FE. Acquisition of funding: FS and MRM. Data collection: MRM, AW, MBP, LKS, PAB, ZI, MK, TS, MLS, PVR, MB and IU. Statistical analysis: MRM, LP and FE. Drafting of the manuscript: MRM. Critical revision of the manuscript for important intellectual content: all authors. Guarantor: FS. In addition, we would like to acknowledge ChatGPT V.3.5 for assisting in improving R coding and phrasing of the manuscript.

  • Funding The authors received an intramural grant for the study from Copenhagen University Hospital – Rigshospitalet (grant number: N/A). FS holds a professorship at the Faculty of Health Sciences and Medicine, University of Copenhagen sponsored by the Danish Multiple Sclerosis Society (grant number: N/A).

  • Competing interests MRM has received support from Merck for participation in a scientific meeting. MM has served on scientific advisory boards, served as a consultant, received support for congress participation, or received speaker honoraria from Roche, Sanofi, Biogen, Merck, Novartis, Bristol Myers Squibb, Medscape, Alexion, and Moderna. Her research group has contracts with Biogen, Merck, Novartis, Roche, Sanofi, and Bristol Myers Squibb. FE has received speaker honoraria from Roche and Sanofi. RPH has received speaker honoraria from Sanofi and Novartis, has served on an advisory board for Novartis, and has received a travel grant from The Danish Multiple Sclerosis Society. AW has served on advisory boards for Merck, Sanofi, Roche, and Biogen. He has also received honoraria for lecturing and manuscript writing from Sanofi, Merck, and Roche and has received financial support for congress participation from Biogen, Sanofi, Novartis, Merck and Roche. MBP reports support for congress participation from Novartis and Merck. ZI has received speaker honoraria, been a member of an advisory board, and received support for congress participation from Sanofi. TS has received travel grants from Sanofi and Merck, research grants from Biogen, Merck and Roche, served on advisory boards for Biogen, Merck, Novartis and Sanofi, and received honoraria for lecturing from Biogen, Merck, Novartis and Sanofi. MLS has received support for congress participation from Biogen, Merck, and Roche and has participated on advisory boards for Sanofi and Roche. PVR has served on scientific advisory boards, received support for congress participation or received speaker honoraria from Biogen, Merck, Novartis, Roche and Sanofi. FS has served on scientific advisory boards, served as a consultant, received support for congress participation or received speaker honoraria from Biogen, Bristol Myers Squibb, H. Lundbeck A/S, Merck, Novartis, Roche and Sanofi. His laboratory has received research support from Biogen, Merck, Novartis, Roche and Sanofi. In addition, FS is section editor of the journal Multiple Sclerosis and Related Disorders, chairman of the research board for the Danish Multiple Sclerosis Society, and member of the scientific steering committee for the International Progressive MS Alliance.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.