Abstract
BackgroundComparative effectiveness (CE) research allows real-world treatment comparisons using outcome measurements important to physicians/patients. This German NeuroTransData registry-based analysis compared delayed-release dimethyl fumarate (DMF) effectiveness with interferons (IFN), glatiramer acetate (GA), teriflunomide (TERI), or fingolimod (FTY) in patients with relapsing–remitting multiple sclerosis (RRMS) using propensity score matching (PSM).MethodsData from registry patients aged ≥ 18 years with RRMS, ≥ 1 relapse, and Expanded Disability Status Scale (EDSS) assessment(s) after index therapy initiation underwent 1:1 PSM to match DMF with comparator populations baseline characteristics. Primary outcome measurement was time to first relapse (TTFR). Secondary outcome measurements included annualised relapse rate (ARR), proportion of patients relapse free at 12 and 24 months, time to index therapy discontinuation (TTD), and reasons for discontinuation. Exploratory analyses included time to 3- and 6-month EDSS confirmed disability progression (CDP). Non-pairwise censoring was the primary analysis method; pairwise censoring was the main sensitivity analysis method.FindingsPost-matched cohorts were well-balanced. By non-pairwise censoring, TTFR and ARR were significantly lower in DMF populations versus matched IFN, GA, and TERI, but there was no evidence of difference between DMF and FTY. TTD was similar between DMF and IFN, GA, and TERI, but significantly shorter versus FTY. Time to CDP generally showed no evidence of difference between DMF and comparator populations. Pairwise censored analysis results confirmed the non-pairwise censoring results.InterpretationThese results support previous CE studies in demonstrating relative improvement in real-world effectiveness with DMF versus first-line agents IFN, GA, and TERI, and similar effectiveness versus FTY.
Highlights
Delayed-release dimethyl fumarate (DMF; known as gastro-resistant DMF) has been shown to be effective for the treatment of relapsing–remitting multiple sclerosis (RRMS) in randomised clinical trials (RCTs), post hoc analyses, and real-world effectiveness studies [1,2,3,4,5]
Post hoc analyses of clinical trial data using mixed treatment comparisons or indirect matching-adjusted methods found DMF was associated with improved efficacy, as Journal of Neurology (2018) 265:2980–2992 mainly assessed by annualised relapse rate (ARR), compared with interferons (IFN), or teriflunomide (TERI), and with similar efficacy compared with fingolimod (FTY) [2, 3, 5]
Baseline characteristics of postmatched populations showed no evidence of a difference as confirmed by small standardised differences (i.e.
Summary
Delayed-release dimethyl fumarate (DMF; known as gastro-resistant DMF) has been shown to be effective for the treatment of relapsing–remitting multiple sclerosis (RRMS) in randomised clinical trials (RCTs), post hoc analyses, and real-world effectiveness studies [1,2,3,4,5]. Post hoc analyses of clinical trial data using mixed treatment comparisons or indirect matching-adjusted methods found DMF was associated with improved efficacy, as Journal of Neurology (2018) 265:2980–2992 mainly assessed by ARR, compared with interferons (IFN), or teriflunomide (TERI), and with similar efficacy compared with fingolimod (FTY) [2, 3, 5]. Comparative effectiveness (CE) research allows real-world treatment comparisons using outcome measurements important to physicians/patients This German NeuroTransData registry-based analysis compared delayed-release dimethyl fumarate (DMF) effectiveness with interferons (IFN), glatiramer acetate (GA), teriflunomide (TERI), or fingolimod (FTY) in patients with relapsing–remitting multiple sclerosis (RRMS) using propensity score matching (PSM). Interpretation These results support previous CE studies in demonstrating relative improvement in real-world effectiveness with DMF versus first-line agents IFN, GA, and TERI, and similar effectiveness versus FTY
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