TY - JOUR

T1 - Early safety and efficacy of fingolimod treatment in Denmark

AU - Voldsgaard, A

AU - Koch-Henriksen, N

AU - Magyari, M

AU - Sellebjerg, F

AU - Sørensen, P S

AU - Oturai, A B

N1 - © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2017/1

Y1 - 2017/1

N2 - BACKGROUND: Initiation of fingolimod treatment is associated with a transient decrease of heart rate, and atrioventricular (AV) conduction block may occur.OBJECTIVE: To evaluate the therapeutic effect and safety of fingolimod treatment in MS patients in Denmark with focus on cardiac and pulmonary side effects at treatment onset.MATERIALS & METHODS: We analysed data from the first 496 fingolimod-treated Danish patients, observed for at least 3 months. In a subset of 204 patients, we monitored cardiac and pulmonary adverse effects following treatment initiation.RESULTS: The overall annualized relapse rate (ARR) was 0.37 (95% CI 0.31-0.44); 0.22 (95% CI 0.03-0.81) in de novo-treated patients, 0.29 (95% CI; 0.23-0.37) in patients switching from IFN-beta or GA and 0.46 (9 5% CI 0.34-0.60) after natalizumab. In the subset of 204 patients, 8 (3.9%) required prolonged cardiac monitoring due to bradycardia and/or second-degree AV block type I. All patients recovered spontaneously. Two patients discontinued fingolimod. Eleven (5.4%) patients reported respiratory complaints and two of these patients discontinued treatment.CONCLUSIONS: Fingolimod appears to be safe and effective in MS patients in a clinical setting. Mild cardiac adverse effects occurred at a similar rate as in clinical trials.

AB - BACKGROUND: Initiation of fingolimod treatment is associated with a transient decrease of heart rate, and atrioventricular (AV) conduction block may occur.OBJECTIVE: To evaluate the therapeutic effect and safety of fingolimod treatment in MS patients in Denmark with focus on cardiac and pulmonary side effects at treatment onset.MATERIALS & METHODS: We analysed data from the first 496 fingolimod-treated Danish patients, observed for at least 3 months. In a subset of 204 patients, we monitored cardiac and pulmonary adverse effects following treatment initiation.RESULTS: The overall annualized relapse rate (ARR) was 0.37 (95% CI 0.31-0.44); 0.22 (95% CI 0.03-0.81) in de novo-treated patients, 0.29 (95% CI; 0.23-0.37) in patients switching from IFN-beta or GA and 0.46 (9 5% CI 0.34-0.60) after natalizumab. In the subset of 204 patients, 8 (3.9%) required prolonged cardiac monitoring due to bradycardia and/or second-degree AV block type I. All patients recovered spontaneously. Two patients discontinued fingolimod. Eleven (5.4%) patients reported respiratory complaints and two of these patients discontinued treatment.CONCLUSIONS: Fingolimod appears to be safe and effective in MS patients in a clinical setting. Mild cardiac adverse effects occurred at a similar rate as in clinical trials.

KW - Adult

KW - Aged

KW - Cardiotoxicity

KW - Denmark

KW - Female

KW - Fingolimod Hydrochloride

KW - Heart Rate

KW - Humans

KW - Immunosuppressive Agents

KW - Male

KW - Middle Aged

KW - Multiple Sclerosis, Relapsing-Remitting

KW - Respiration

KW - Journal Article

KW - Observational Study

U2 - 10.1111/ane.12573

DO - 10.1111/ane.12573

M3 - Journal article

C2 - 27910101

VL - 135

SP - 129

EP - 133

JO - Acta Neurologica Scandinavica

JF - Acta Neurologica Scandinavica

SN - 0001-6314

IS - 1

ER -