scholarly journals Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

2018 ◽  
Vol 11 ◽  
pp. 175628641879640 ◽  
Author(s):  
Emanuele D’Amico ◽  
Aurora Zanghì ◽  
Graziella Callari ◽  
Giovanna Borriello ◽  
Antonio Gallo ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Comparable Efficacy ◽  
Real Word ◽  
Efficacy And Safety ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

scholarly journals Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing–remitting multiple sclerosis (RRMS)

2014 ◽  
Vol 21 (1) ◽  
pp. 57-66 ◽  
Author(s):  
Ralf Gold ◽  
Gavin Giovannoni ◽  
J Theodore Phillips ◽  
Robert J Fox ◽  
Annie Zhang ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Delayed Release ◽  
Disease Modifying Therapy ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

Background: Delayed-release dimethyl fumarate (DMF) demonstrated efficacy and safety in the Phase 3 DEFINE and CONFIRM trials. Objective: To evaluate delayed-release DMF in newly diagnosed relapsing–remitting multiple sclerosis (RRMS) patients, in a post-hoc analysis of integrated data from DEFINE and CONFIRM. Methods: Patients included in the analysis were diagnosed with RRMS within 1 year prior to study entry and naive to MS disease-modifying therapy. Results: The newly diagnosed population comprised 678 patients treated with placebo ( n = 223) or delayed-release DMF 240 mg BID ( n = 221) or TID ( n = 234). At 2 years, delayed-release DMF BID and TID reduced the annualized relapse rate by 56% and 60% (both p < 0.0001), risk of relapse by 54% and 57% (both p < 0.0001), and risk of 12-week confirmed disability progression by 71% ( p < 0.0001) and 47% ( p = 0.0085) versus placebo. In a subset of patients (MRI cohort), delayed-release DMF BID and TID reduced the mean number of new or enlarging T2-hyperintense lesions by 80% and 81%, gadolinium-enhancing lesion activity by 92% and 92%, and mean number of new non-enhancing T1-hypointense lesions by 68% and 70% (all p < 0.0001 versus placebo). Flushing and gastrointestinal events were associated with delayed-release DMF. Conclusion: Delayed-release DMF improved clinical and neuroradiological outcomes relative to placebo in newly diagnosed RRMS patients.

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 Comparable Efficacy and Safety of Teriflunomide versus Dimethyl Fumarate for the Treatment of Relapsing-Remitting Multiple Sclerosis

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Nasim Nehzat ◽  
Omid Mirmosayyeb ◽  
Mahdi Barzegar ◽  
Reza Vosoughi ◽  
Erfane Fazeli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Treated Group ◽  
Oral Disease ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Relapsing Remitting ◽  
Study Population ◽  
Matching Score ◽  
Relapsing Remitting Multiple Sclerosis

Background. The aim of this observational study is to investigate the efficacy and safety of two approved oral disease-modifying therapies (DMTs) in patients with remitting-relapsing multiple sclerosis (RRMS): dimethyl fumarate (DMF) vs. teriflunomide (TRF). Methods. A total of 159 RRMS patients (82 on TRF and 77 on DMF) were included. The expanded disability status scale (EDSS), confirmed disability improvement (CDI), confirmed disability progression (CDP), and annualized relapse rate (ARR) were evaluated for the two-year period prior to enrollment in our study. The drug-associated adverse effects (AEs) were recorded. We conducted propensity matching score to compare the efficacy between TRF and DMF. Results. After matching for the confounders, TRF- and DMF-treated groups were not different in terms of EDSS ( P value = 0.54), CDI ( P value = 0.80), CDP ( P value = 0.39), and ARR ( P value >0.05). TRF discontinuation occurred in 2 patients (2.43%) due to mediastinitis and liver dysfunction, while a patient (1.29%) discontinued DMF due to depression. Incidence rate of AEs in the TRF-treated group was 81.4%: hair thinning (hair loss) (62.9%), nail loss (20.9%), and elevated aminotransferase (14.8%) were the most common AEs; in DMF-treated patients, AEs were 88.2% with predominance of flushing (73.2%), pruritus (16.9%), and abdominal pain (16.9%). Conclusion. Based on our findings, DMF is as efficacious and safe as TRF for the treatment of RRMS in our Iranian study population. Multicentric studies need to corroborate these findings in other populations.

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