A comparison of multiple sclerosis clinical disease activity between patients treated with natalizumab and fingolimod
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A comparison of multiple sclerosis clinical disease activity between patients treated with natalizumab and fingolimod. / Koch-Henriksen, Nils; Magyari, Melinda; Sellebjerg, Finn; Soelberg Sørensen, Per.
I: Multiple Sclerosis, Bind 23, Nr. 2, 02.2017, s. 234-241.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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 -
ID: 188479471