TY - JOUR

T1 - A comparison of multiple sclerosis clinical disease activity between patients treated with natalizumab and fingolimod

AU - Koch-Henriksen, Nils

AU - Magyari, Melinda

AU - Sellebjerg, Finn

AU - Soelberg Sørensen, Per

PY - 2017/2

Y1 - 2017/2

N2 - Background: Natalizumab and fingolimod were approved for treatment of active relapsing-remitting multiple sclerosis (RRMS) in Denmark in 2006 and 2011, respectively. There have been no randomized head-to-head studies comparing the two drugs. Objective: To compare the clinical efficacy of natalizumab and fingolimod. Methods: Data on all Danish RRMS patients who started their first second-line treatment with natalizumab or fingolimod from July 2011 to March 2015 were prospectively recorded in the Danish Multiple Sclerosis (MS) Treatment Register. The two treatment arms were 1:1 propensity score matched by baseline covariates using 'nearest neighbour' method. Results: Propensity score matching left 928 of 1309 RRMS cases, 464 in each treatment group. The on-treatment annualized relapse rate was 0.296 (95% confidence interval (CI): 0.26-0.34) for natalizumab and 0.307 (95% CI: 0.27-0.35) for fingolimod. The adjusted relapse rate ratio was 0.93 (95% CI: 0.74-1.17; p = 0.53). Mean time to first relapse was 2.55 and 2.56 years, respectively (p = 0.76). There was no difference in change of Expanded Disability Status Scale (EDSS). Conclusion: We found no differences in clinical disease activity between natalizumab- and fingolimod-treated RRMS patients in this real-life observational study. However, the lack of magnetic resonance imaging (MRI) data for the propensity score matching may conceal a higher efficacy of natalizumab.

AB - Background: Natalizumab and fingolimod were approved for treatment of active relapsing-remitting multiple sclerosis (RRMS) in Denmark in 2006 and 2011, respectively. There have been no randomized head-to-head studies comparing the two drugs. Objective: To compare the clinical efficacy of natalizumab and fingolimod. Methods: Data on all Danish RRMS patients who started their first second-line treatment with natalizumab or fingolimod from July 2011 to March 2015 were prospectively recorded in the Danish Multiple Sclerosis (MS) Treatment Register. The two treatment arms were 1:1 propensity score matched by baseline covariates using 'nearest neighbour' method. Results: Propensity score matching left 928 of 1309 RRMS cases, 464 in each treatment group. The on-treatment annualized relapse rate was 0.296 (95% confidence interval (CI): 0.26-0.34) for natalizumab and 0.307 (95% CI: 0.27-0.35) for fingolimod. The adjusted relapse rate ratio was 0.93 (95% CI: 0.74-1.17; p = 0.53). Mean time to first relapse was 2.55 and 2.56 years, respectively (p = 0.76). There was no difference in change of Expanded Disability Status Scale (EDSS). Conclusion: We found no differences in clinical disease activity between natalizumab- and fingolimod-treated RRMS patients in this real-life observational study. However, the lack of magnetic resonance imaging (MRI) data for the propensity score matching may conceal a higher efficacy of natalizumab.

KW - comparison

KW - efficacy

KW - fingolimod

KW - Multiple sclerosis

KW - natalizumab

KW - relapsing remitting

U2 - 10.1177/1352458516643393

DO - 10.1177/1352458516643393

M3 - Journal article

C2 - 27055806

AN - SCOPUS:85011845598

VL - 23

SP - 234

EP - 241

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

SN - 1352-4585

IS - 2

ER -