Prognostic Factors of Disease Activity in Newly Diagnosed Teriflunomide-treated Patients with Multiple Sclerosis—A Nationwide Danish Study
Mie Reith Mahler1, Melinda Magyari1, Luigi Pontieri1, Frederik Elberling1, Arkadiusz Weglewski2, Mai Bang Poulsen3, Plamen Bekyarov4, Zsolt Illes4, Matthias Kant5, Tobias Sejbaek6, Morten Leif Munding Stilund7, Peter Rasmussen8, Maria Brask9, Inga Urbonaviciute10, Finn Sellebjerg1
1The Danish Multiple Sclerosis Registry, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital – Rigshospitalet, 2Department of Neurology and Department of Clinical Medicine, Herlev-Gentofte Hospital and University of Copenhagen, 3Department of Neurology, Nordsjællands Hospital, 4Department of Neurology, Odense University Hospital, 5Department of Neurology, Sygehus Soenderjylland, 6Department of Neurology, Esbjerg Hospital, 7Department of Neurology, Goedstrup Hospital, 8Department of Neurology, Aarhus University Hospital, 9Department of Neurology, Viborg Regional Hospital, 10Department of Neurology, Aalborg University Hospital
Objective:
To investigate the prognostic effect of relapse count, T2 MRI lesion load (T2L), Expanded Disability Status Scale (EDSS) scores, age, and sex in patients newly diagnosed with multiple sclerosis (MS) commencing teriflunomide (TFL) treatment.
Background:
Physicians frequently rely on relapse counts, T2L, and EDSS scores to help guide treatment decisions for newly diagnosed individuals. The expanding number of treatment options highlights the necessity of improved prediction of individual disease trajectories.
Design/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, pre-treatment relapses, T2L, and EDSS scores on the risk of disease activity on TFL were analysed stratified by sex using the Aalen-Johansen estimator, a time-fixed binomial regression model, and a proportional odds cumulative incidence model.
Results:
In total 784 individuals were included (57.4 % females). A high number of pre-treatment relapses (≥2) was associated with an increased risk of disease activity (odds ratio [OR] and 95% CI: 1.76 [1.11 – 2.81]) in females only. Age group 50+ was associated with lower risk of disease activity in both sexes (ORfemales 0.28 [0.14 – 0.56]; ORmales 0.22 [0.09 – 0.55]), and in addition, age group 35-49 was also associated with lower risk of disease activity in males (OR 0.42 [0.24 - 0.72]). EDSS scores and T2L did not show any consistent association with disease activity.
Conclusions:
A high number of pre-treatment relapses was only associated with an increased risk of disease activity in females. In males higher age was associated with lower risk of disease activity, while only age 50+ was associated with lower risk in females. Clinicians may consider age, sex and relapses when deciding on TFL treatment.