Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 24-month follow-up

Hersh, Carrie M.; Love, Thomas E.; Bandyopadhyay, Anasua; Cohn, Samuel; Hara-Cleaver, Claire; Bermel, Robert; Fox, Robert J.; Cohen, Jeffrey A.; Ontaneda, Daniel

doi:10.1177/2055217317715485

Cited by 33 publications

(53 citation statements)

References 28 publications

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“…A single-centre propensity score-weighted study among 659 patients did not find a statistically significant difference in the rate of relapses between patients treated with fingolimod or dimethyl fumarate over 2 years. In that study, 0.20–0.21 on-treatment relapses per patient and year were reported, but the mean time to the first relapse was markedly longer in fingolimod (7.56 months) than dimethyl fumarate (3.83 months) 10. A network meta-analysis of two pooled post hoc analyses of placebo-controlled trials reported non-significant trends favouring fingolimod over dimethyl fumarate in relapse frequency and 3-month confirmed disability progression in highly active MS 7…”

Section: Discussionmentioning

confidence: 85%

Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

Kalinčík

Havrdová

Horáková

et al. 2019

J Neurol Neurosurg Psychiatry

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ObjectiveOral immunotherapies have become a standard treatment in relapsing-remitting multiple sclerosis. Direct comparison of their effect on relapse and disability is needed.MethodsWe identified all patients with relapsing-remitting multiple sclerosis treated with teriflunomide, dimethyl fumarate or fingolimod, with minimum 3-month treatment persistence and disability follow-up in the global MSBase cohort study. Patients were matched using propensity scores. Three pairwise analyses compared annualised relapse rates and hazards of disability accumulation, disability improvement and treatment discontinuation (analysed with negative binomial models and weighted conditional survival models, with pairwise censoring).ResultsThe eligible cohorts consisted of 614 (teriflunomide), 782 (dimethyl fumarate) or 2332 (fingolimod) patients, followed over the median of 2.5 years. Annualised relapse rates were lower on fingolimod compared with teriflunomide (0.18 vs 0.24; p=0.05) and dimethyl fumarate (0.20 vs 0.26; p=0.01) and similar on dimethyl fumarate and teriflunomide (0.19 vs 0.22; p=0.55). No differences in disability accumulation (p≥0.59) or improvement (p≥0.14) were found between the therapies. In patients with ≥3-month treatment persistence, subsequent discontinuations were less likely on fingolimod than teriflunomide and dimethyl fumarate (p<0.001). Discontinuation rates on teriflunomide and dimethyl fumarate were similar (p=0.68).ConclusionThe effect of fingolimod on relapse frequency was superior to teriflunomide and dimethyl fumarate. The effect of the three oral therapies on disability outcomes was similar during the initial 2.5 years on treatment. Persistence on fingolimod was superior to the two comparator drugs.

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Section: Discussionmentioning

confidence: 85%

Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

Kalinčík

Havrdová

Horáková

et al. 2019

J Neurol Neurosurg Psychiatry

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“…[10][11][12] There were no substantial differences regarding the 12 and 24 months analyses. In comparison with two studies with an observation period of 24 months and another study with an observation period of 12 months, we found similar relapse rates.…”

Section: Re Sultsmentioning

confidence: 80%

“…4 No difference in ARR between teriflunomide and IFNβ-1a was seen in TENERE. [9][10][11][12][13][14][15] These discrepancies ask for further investigations to confirm or rebut the published findings. [9][10][11][12][13][14][15] These discrepancies ask for further investigations to confirm or rebut the published findings.…”

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confidence: 91%

Real‐life use of oral disease‐modifying treatments in Austria

et al. 2019

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Objectives To compare the efficacy, frequencies and reasons for treatment interruption of fingolimod, dimethyl fumarate (DMF) or teriflunomide in a nationwide observational cohort using prospectively collected data. Materials and methods Two cohorts of patients with relapsing‐remitting multiple sclerosis (RRMS) starting treatment with fingolimod, dimethyl fumarate or teriflunomide documented in the Austrian MS Treatment Registry (AMSTR) since 2014 and either staying on therapy for at least 12 months (12m cohort) or having at least one follow‐up visit (total cohort). The 12m cohort included 664 RRMS patients: 315 in the fingolimod, 232 in the DMF and 117 in the teriflunomide group. Multinomial propensity scores were used for inverse probability weighting to correct for the bias of this non‐randomised registry study. Results Estimated mean annualized relapse rates (ARR) over 12 months were 0.21 for fingolimod, 0.20 for DMF and 0.19 for teriflunomide treatment, causing an incidence rate ratio (IRR) of 1.01 for fingolimod vs DMF (P = 0.96) and 0.92 for teriflunomide vs DMF (P = 0.84). No differences were found regarding the probability for experiencing a relapse, EDSS change, EDSS progression and EDSS regression, except regarding less sustained EDSS progression for 12 weeks concerning DMF vs fingolimod (P = 0.02). The hazard ratio for treatment interruption comparing fingolimod vs DMF was 1.03 (P = 0.86) and 1.07 comparing teriflunomide vs DMF (P = 0.77). Conclusions In the AMSTR, there was no difference concerning ARR, probability for a relapse, EDSS change, treatment interruption, EDSS progression or regression between oral DMTs, except regarding less sustained EDSS progression for 12 weeks concerning DMF vs fingolimod.

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“…Dimethyl fumarate has been compared with a number of alternative treatments using CE research methods, including claims-based analyses [7, 8], a cross-sectional study [9], and a number of PSM analyses based on registries [10–14]. In the PSM analyses performed to date, DMF showed improved clinical effectiveness in terms of reductions in ARR and time to first relapse (TTFR) events versus IFN, GA, and TERI [13, 14], and a similar rate of relapse as FTY [10–12, 14].…”

Section: Introductionmentioning

confidence: 99%

“…In the PSM analyses performed to date, DMF showed improved clinical effectiveness in terms of reductions in ARR and time to first relapse (TTFR) events versus IFN, GA, and TERI [13, 14], and a similar rate of relapse as FTY [10–12, 14]. To support this growing body of real-world evidence, this CE analysis based on the German NeuroTransData (NTD) multiple sclerosis (MS) registry was conducted to assess real-world CE of DMF compared with IFN, GA, TERI, and FTY in PSM cohorts of patients with RRMS.…”

Section: Introductionmentioning

confidence: 99%

Comparative effectiveness of delayed-release dimethyl fumarate versus interferon, glatiramer acetate, teriflunomide, or fingolimod: results from the German NeuroTransData registry

et al. 2018

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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.Electronic supplementary materialThe online version of this article (10.1007/s00415-018-9083-5) contains supplementary material, which is available to authorized users.

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Comparative efficacy and discontinuation of dimethyl fumarate and fingolimod in clinical practice at 24-month follow-up

Cited by 33 publications

References 28 publications

Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

Real‐life use of oral disease‐modifying treatments in Austria

Comparative effectiveness of delayed-release dimethyl fumarate versus interferon, glatiramer acetate, teriflunomide, or fingolimod: results from the German NeuroTransData registry

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