scholarly journals Comparative analysis of dimethyl fumarate and fingolimod in relapsing–remitting multiple sclerosis

2020 ◽  
Author(s):  
Johannes Lorscheider ◽  
Pascal Benkert ◽  
Carmen Lienert ◽  
Peter Hänni ◽  
Tobias Derfuss ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Oral Disease ◽  
Relapsing Remitting ◽  
Treatment Naïve ◽  
Baseline Characteristics ◽  
Remitting Multiple Sclerosis ◽  
Incident Rate ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Relapse Rates

Abstract Background Dimethyl fumarate and fingolimod are oral disease modifying treatments (DMTs) that reduce relapse activity and slow disability worsening in relapsing–remitting multiple sclerosis (RRMS). Objective To compare the effectiveness of dimethyl fumarate and fingolimod in a real-world setting, where both agents are licensed as a first-line DMT for the treatment of RRMS. Methods We identified patients with RRMS commencing dimethyl fumarate or fingolimod in the Swiss Federation for Common Tasks of Health Insurances (SVK) Registry between August 2014 and July 2019. Propensity score-matching was applied to select subpopulations with comparable baseline characteristics. Relapses and disability outcomes were compared in paired, pairwise-censored analyses. Results Of the 2113 included patients, 1922 were matched (dimethyl fumarate, n = 961; fingolimod, n = 961). Relapse rates did not differ between the groups (incident rate ratio 1.0, 95%CI 0.8–1.2, p = 0.86). Moreover, no difference in the hazard of 1-year confirmed disability worsening (hazard ratio [HR] 0.9; 95%CI 0.6–1.6; p = 0.80) or disability improvement (HR 0.9; 95%CI 0.6–1.2; p = 0.40) was detected. These findings were consistent both for treatment-naïve patients and patients switching from another DMT. Conclusion Dimethyl fumarate and fingolimod have comparable effectiveness regarding reduction of relapses and disability worsening in RRMS.

Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

2019 ◽  
Vol 90 (4) ◽  
pp. 458-468 ◽  
Author(s):  
Tomas Kalincik ◽  
Eva Kubala Havrdova ◽  
Dana Horakova ◽  
Guillermo Izquierdo ◽  
Alexandre Prat ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Propensity Scores ◽  
Negative Binomial ◽  
Dimethyl Fumarate ◽  
Survival Models ◽  
Treatment Persistence ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Relapse Rates

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.

scholarly journals Efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with multiple sclerosis: Interim analysis of the randomized placebo-controlled study

2019 ◽  
Vol 5 (2) ◽  
pp. 205521731985272 ◽  
Author(s):  
Masahiro Mori ◽  
Takashi Ohashi ◽  
Yasuhiro Onizuka ◽  
Katsutoshi Hiramatsu ◽  
Masakazu Hase ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Japanese Patients ◽  
Dimethyl Fumarate ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Number Of Patients ◽  
Relapsing Remitting ◽  
Treatment Naïve ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background The use of dimethyl fumarate has not been reported in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis. Objectives The purpose of this study was to evaluate the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis. Methods APEX was a phase 3, multinational trial, which consisted of a 24-week, randomized (1:1), double-blind study where patients received dimethyl fumarate 240 mg or placebo twice daily, followed by an open-label extension where all patients received dimethyl fumarate 240 mg. The primary endpoints were the total number of new gadolinium-enhancing (Gd+) lesions in Weeks 12–24 (Part I) and long-term safety (Part II). This post-hoc subgroup analysis evaluated the efficacy and safety of dimethyl fumarate in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis ( n=52) up to Week 72 (24 weeks Part I and 48 weeks Part II). Results Dimethyl fumarate reduced the mean total number of new gadolinium-enhancing lesions at Weeks 12–24 by 94% versus placebo; the number of patients who had a relapse over 24 weeks was reduced by 72%. Adverse events leading to discontinuation of the study drug were reported in 9% of patients receiving placebo/dimethyl fumarate and 4% of patients in dimethyl fumarate/dimethyl fumarate. Conclusions Dimethyl fumarate demonstrated sustained efficacy and acceptable tolerability in treatment-naïve Japanese patients with relapsing–remitting multiple sclerosis for 72 weeks.

scholarly journals Dimethyl fumarate for relapsing-remitting multiple sclerosis

2014 ◽  
Vol 13 (11) ◽  
pp. 1077-1078
Author(s):  
Martyn J Burke ◽  
Joanna Richardson ◽  
Elisabeth George ◽  
Amanda I Adler
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Dimethyl fumarate–associated transient bone marrow oedema syndrome

2018 ◽  
Vol 25 (6) ◽  
pp. 876-879 ◽  
Author(s):  
James Triplett ◽  
Srimathy Vijayan ◽  
Richard Prince ◽  
Allan Kermode
Keyword(s):  
Multiple Sclerosis ◽  
Bone Marrow ◽  
Dimethyl Fumarate ◽  
Symptomatic Improvement ◽  
Bone Marrow Oedema ◽  
Related Factor ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
And Function ◽  
Relapsing Remitting Multiple Sclerosis

Background: Dimethyl fumarate (DMF) is a commonly used and effective treatment for relapsing and remitting multiple sclerosis. Its use results in impairment of the transcription factor nuclear factor erythroid-derived 2 (E2)-related factor (Nrf2), which is involved in both immunomodulation and bone health. DMF has not previously been reported to cause bone marrow complications, though other fumarates including tenofovir have. The mechanism of fumarate-associated bone toxicity remains unclear with altered osteoblastic gene expression and function suggested. Methods: We present a case of a 54-year-old female with relapsing remitting multiple sclerosis (RRMS) treated for 30 months with DMF who developed relapsing atraumatic lower limb bone pain. Results: Serial imaging revealed multifocal areas of bone marrow oedema and trabecular fractures. The patient was diagnosed with transient bone marrow oedema syndrome. Management consisted of cessation of therapy and treatment with the pro-osteobalstic agent denosumab. Conclusion: In this instance of DMF-associated bone marrow oedema, cessation of DMF and treatment with denosumab resulted in symptomatic improvement. DMF therapy may potentially result in bone marrow oedema due to inhibition of common upstream signalling pathways, including the Nrf2 signalling pathway.

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