Dataset Information

The effectiveness of interferon beta versus glatiramer acetate and natalizumab versus fingolimod in a Polish real-world population.

ABSTRACT: OBJECTIVE:The aim of the study was to assess the effectiveness of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients treated in MS centres in Poland. METHODS:Demographic and clinical data of all Polish RRMS patients receiving DMTs were prospectively collected from 2014 to 2018 in electronic files using the Therapeutic Program Monitoring System (SMPT). RESULTS:The study included 10,764 RRMS patients treated with DMTs in first-line and 1,042 in second-line programmes. IFN? more effectively lengthened the times to the first relapse, disability progression, and brain MRI activity than GA. After 2 and 4 years of follow-up, more patients on IFN? showed no evidence of disease activity (NEDA-3) in comparison to GA (66.3% and 44.3% vs 55.2% and 33.2%, respectively; p<0.001). NAT more effectively reduced brain MRI activity than FTY (p = 0.001). More patients under NAT had NEDA-3 after 2 and 4 years of follow-up compared to FTY (66.2% and 42.1% vs 52.1% and 29.5%, respectively; p = 0.03). In adjusted analysis, a higher baseline Expanded Disability Status Score (EDSS) was a predictor of relapse (p<0.001) and NEDA-3 failure (p = 0.003). CONCLUSION:IFN? compared to GA and NAT compared to FTY more effectively reduced disease activity in a Polish population of RRMS patients.

SUBMITTER: Kapica-Topczewska K

PROVIDER: S-EPMC6812766 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The effectiveness of interferon beta versus glatiramer acetate and natalizumab versus fingolimod in a Polish real-world population.

Kapica-Topczewska Katarzyna K Tarasiuk Joanna J Collin Francois F Brola Waldemar W Chorąży Monika M Czarnowska Agata A Kwaśniewski Mirosław M Bartosik-Psujek Halina H Adamczyk-Sowa Monika M Kochanowicz Jan J Kułakowska Alina A

PloS one 20191024 10

<h4>Objective</h4>The aim of the study was to assess the effectiveness of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients treated in MS centres in Poland.<h4>Methods</h4>Demographic and clinical data of all Polish RRMS patients receiving DMTs were prospectively collected from 2014 to 2018 in electronic files using the Therapeutic Program Monitoring System (SMPT).<h4>Results</h4>The study included 10,764 RRMS patients treated with DMTs in first-line an ...[more]

PMID: 31647829

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Project description:BackgroundWe compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-? (IFN-?)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries.MethodsThe study population initiated IFN-?/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ?3 months of on-treatment follow-up, and had active RRMS, defined as ?1 gadolinium-enhancing lesion on cerebral MRI at baseline or ?1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity.ResultsFirst-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-?/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p = 0.01), compared with first-line IFN-?/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups.ConclusionsThis study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-?/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients.Classification of evidenceThis study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-?/GA.

Project description:IntroductionLimited comparative effectiveness data for rituximab (RTX) versus natalizumab (NTZ), fingolimod (FTY), and dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS) exist.MethodsClinician-reported data on patients prescribed RTX, NTZ, FTY, or DMF for the treatment of MS at the Rocky Mountain MS Center at the University of Colorado were retrospectively collected. Outcomes included a composite effectiveness measure consisting of clinical relapse, contrast-enhancing lesions, and/or new T2 lesions, individual effectiveness outcomes, and discontinuation. Logistic regression was used on patients matched by propensity scores and using average treatment effect on treated doubly robust weighting estimator.ResultsA total of 182, 451, 271, and 342 patients initiated RTX, NTZ, FTY, and DMF and were followed for 2 years. Before and after adjustment, the odds of experiencing disease activity was significantly higher for FTY [adjusted OR (aOR) = 3.17 (95% CI: 1.81-5.55), P < 0.001].and DMF [aOR = 2.68 (95% CI:1.67-4.29), P < 0.001], and similar for NTZ [aOR = 1.36 (95% CI:0.83-2.23), P = 0.216] versus RTX. When examining months 6-24, NTZ demonstrated higher odds of disease activity compared to RTX [aOR = 2.21 (95% CI: 1.20-4.06), P = 0.007]. Similar odds of discontinuation were seen between NTZ and RTX [aOR = 1.39 (95% CI: 0.88-2.20), P = 0.157]; however, FTY [aOR = 2.02 (95% CI: 1.24-3.30), P = 0.005] and DMF [aOR = 3.27 (95% CI: 2.15-4.97), P < 0.001] had greater odds of discontinuation than RTX.InterpretationRTX demonstrated superior effectiveness and discontinuation outcomes compared to FTY and DMF. Although RTX demonstrated similar effectiveness and discontinuation compared to NTZ, RTX had superior effectiveness during months 6-24 and fewer discontinuations when excluding discontinuations due to insurance issues. Results suggest superiority of RTX in reducing disease activity and maintaining long-term treatment in a real-world MS cohort.

Dataset Information

The effectiveness of interferon beta versus glatiramer acetate and natalizumab versus fingolimod in a Polish real-world population.

Publications

The effectiveness of interferon beta versus glatiramer acetate and natalizumab versus fingolimod in a Polish real-world population.

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