TY - JOUR
T1 - Initial high-efficacy disease-modifying therapy in multiple sclerosis
T2 - A nationwide cohort study
AU - Buron, Mathias Due
AU - Chalmer, Thor Ameri
AU - Sellebjerg, Finn
AU - Barzinji, Ismael
AU - Christensen, Jeppe Romme
AU - Christensen, Mette Kirstine
AU - Hansen, Victoria
AU - Illes, Zsolt
AU - Jensen, Henrik Boye
AU - Kant, Matthias
AU - Papp, Viktoria
AU - Petersen, Thor
AU - Rasmussen, Peter Vestergaard
AU - Schäfer, Jakob
AU - Theódórsdóttir, Ásta
AU - Weglewski, Arkadiusz
AU - Sorensen, Per Soelberg
AU - Magyari, Melinda
N1 - © 2020 American Academy of Neurology.
PY - 2020/8/25
Y1 - 2020/8/25
N2 - OBJECTIVE: To determine the effectiveness of high-efficacy disease-modifying therapies (heDMTs) vs medium-efficacy disease-modifying therapies (meDMT) as the first treatment choice in treatment-naive patients with multiple sclerosis (MS) on disability worsening and relapses. We assessed this using a nationwide population-based MS registry.METHODS: We identified all patients starting a heDMT as first-time treatment from the Danish Multiple Sclerosis Registry and compared treatment outcomes with a propensity score matched sample of patients starting meDMT.RESULTS: We included 388 patients in the study: 194 starting initial therapy with heDMT matched to 194 patients starting meDMT. At 4 years of follow-up, the probabilities of a 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening were 16.7% (95% confidence interval [CI] 10.4%-23.0%) and 30.1% (95% CI 23.1%-37.1%) for heDMT and meDMT initiators, respectively (hazard ratio [HR] 0.53, 95% CI 0.33-0.83, p = 0.006). Patients initiating heDMT also had a lower probability of a first relapse (HR 0.50, 95% CI 0.37-0.67). Results were similar after pairwise censoring and in subgroups with high baseline activity, diagnosis after 2006, or information on baseline T2 lesion load.CONCLUSION: We found a lower probability of 6-month confirmed EDSS score worsening and lower probability of a first relapse in patients starting a heDMT as first therapy, compared to a matched sample starting meDMT.CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with MS, starting heDMT lowers the risk of EDSS worsening and relapses compared to starting meDMT.
AB - OBJECTIVE: To determine the effectiveness of high-efficacy disease-modifying therapies (heDMTs) vs medium-efficacy disease-modifying therapies (meDMT) as the first treatment choice in treatment-naive patients with multiple sclerosis (MS) on disability worsening and relapses. We assessed this using a nationwide population-based MS registry.METHODS: We identified all patients starting a heDMT as first-time treatment from the Danish Multiple Sclerosis Registry and compared treatment outcomes with a propensity score matched sample of patients starting meDMT.RESULTS: We included 388 patients in the study: 194 starting initial therapy with heDMT matched to 194 patients starting meDMT. At 4 years of follow-up, the probabilities of a 6-month confirmed Expanded Disability Status Scale (EDSS) score worsening were 16.7% (95% confidence interval [CI] 10.4%-23.0%) and 30.1% (95% CI 23.1%-37.1%) for heDMT and meDMT initiators, respectively (hazard ratio [HR] 0.53, 95% CI 0.33-0.83, p = 0.006). Patients initiating heDMT also had a lower probability of a first relapse (HR 0.50, 95% CI 0.37-0.67). Results were similar after pairwise censoring and in subgroups with high baseline activity, diagnosis after 2006, or information on baseline T2 lesion load.CONCLUSION: We found a lower probability of 6-month confirmed EDSS score worsening and lower probability of a first relapse in patients starting a heDMT as first therapy, compared to a matched sample starting meDMT.CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with MS, starting heDMT lowers the risk of EDSS worsening and relapses compared to starting meDMT.
KW - Adult
KW - Cohort Studies
KW - Denmark
KW - Female
KW - Humans
KW - Immunologic Factors/therapeutic use
KW - Male
KW - Middle Aged
KW - Multiple Sclerosis, Relapsing-Remitting/drug therapy
KW - Treatment Outcome
U2 - 10.1212/WNL.0000000000010135
DO - 10.1212/WNL.0000000000010135
M3 - Journal article
C2 - 32636328
SN - 0028-3878
VL - 95
SP - e1041-e1051
JO - Neurology
JF - Neurology
IS - 8
M1 - 32636328
ER -