TY - JOUR
T1 - Risk of hypertension in patients with multiple sclerosis treated with teriflunomide compared to dimethyl fumarate
T2 - A nationwide cohort study in Denmark
AU - Framke, Elisabeth
AU - Sellebjerg, Finn
AU - Kant, Matthias
AU - Stilund, Morten
AU - Jensen, Henrik Boye
AU - Illés, Zsolt Laszlo
AU - Asgari, Nasrin
AU - Sejbaek, Tobias
AU - Roug, Lena Christina
AU - Jensen, Michael Broksgaard
AU - Schäfer, Jakob
AU - Rasmussen, Peter Vestergaard
AU - Christensen, Jeppe Romme
AU - Weglewski, Arkadiusz
AU - Prakash, Sivagini
AU - Magyari, Melinda
AU - DMSG study group
PY - 2025/1
Y1 - 2025/1
N2 - Background: Teriflunomide has been associated with an increased risk of hypertension. Real-world studies including adequate control groups are lacking. We hypothesized that patients with multiple sclerosis (MS) treated with teriflunomide would be at higher risk of developing hypertension than those treated with dimethyl fumarate. Methods: We conducted a cohort study linking the Danish Multiple Sclerosis Registry with national health registries during a 10-year period. Teriflunomide (N = 2656) and dimethyl fumarate (N = 2237) exposure was defined by the first treatment record lasting ⩾ 3 months, at which time follow-up started. We included 4893 adult patients without hypertension at baseline. Hypertension was defined as an International Classification of Diseases 10th Revision code for hypertension and by dispensed prescription drugs identified by the respective Anatomical Therapeutic Chemical codes. We used multivariable-adjusted Cox regression. Results: We found 40.6 (teriflunomide) and 13.1 (dimethyl fumarate) hypertension events per 1000 person-years. Compared to dimethyl fumarate-treated patients, patients treated with teriflunomide had a higher risk of developing hypertension (adjusted hazard ratio = 2.80; 95% confidence interval = 2.19–3.56). The number needed to harm was 16 and 9 at 3 and 5 years of follow-up, respectively. Conclusion: We found an increased risk of hypertension in adult patients with MS treated with teriflunomide.
AB - Background: Teriflunomide has been associated with an increased risk of hypertension. Real-world studies including adequate control groups are lacking. We hypothesized that patients with multiple sclerosis (MS) treated with teriflunomide would be at higher risk of developing hypertension than those treated with dimethyl fumarate. Methods: We conducted a cohort study linking the Danish Multiple Sclerosis Registry with national health registries during a 10-year period. Teriflunomide (N = 2656) and dimethyl fumarate (N = 2237) exposure was defined by the first treatment record lasting ⩾ 3 months, at which time follow-up started. We included 4893 adult patients without hypertension at baseline. Hypertension was defined as an International Classification of Diseases 10th Revision code for hypertension and by dispensed prescription drugs identified by the respective Anatomical Therapeutic Chemical codes. We used multivariable-adjusted Cox regression. Results: We found 40.6 (teriflunomide) and 13.1 (dimethyl fumarate) hypertension events per 1000 person-years. Compared to dimethyl fumarate-treated patients, patients treated with teriflunomide had a higher risk of developing hypertension (adjusted hazard ratio = 2.80; 95% confidence interval = 2.19–3.56). The number needed to harm was 16 and 9 at 3 and 5 years of follow-up, respectively. Conclusion: We found an increased risk of hypertension in adult patients with MS treated with teriflunomide.
KW - dimethyl fumarate
KW - hypertension
KW - multiple sclerosis
KW - safety
KW - Teriflunomide
KW - Toluidines/adverse effects
KW - Humans
KW - Middle Aged
KW - Male
KW - Hypertension/epidemiology
KW - Dimethyl Fumarate/adverse effects
KW - Crotonates/adverse effects
KW - Hydroxybutyrates
KW - Multiple Sclerosis/drug therapy
KW - Denmark/epidemiology
KW - Nitriles/adverse effects
KW - Immunosuppressive Agents/adverse effects
KW - Female
KW - Adult
KW - Registries
KW - Cohort Studies
U2 - 10.1177/13524585241299715
DO - 10.1177/13524585241299715
M3 - Journal article
C2 - 39632560
AN - SCOPUS:85211199544
SN - 1352-4585
VL - 31
SP - 36
EP - 43
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 1
ER -