- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Clinical, Journal: Effects of multiple sclerosis disease-modifying therapies on employment measures using patient-reported data. (Pubmed Central) - Oct 9, 2019 If drug prices were lowered, more DMTs could be cost effective. Those using the higher efficacy (category 3) DMTs, particularly fingolimod and natalizumab, reported significant increases in amount of work, work attendance and work productivity, suggesting they have important beneficial effects on work life in people with MS.
- |||||||||| Clinical, Review, Journal: Cancer Risk in Patients with Multiple Sclerosis: Potential Impact of Disease-Modifying Drugs. (Pubmed Central) - Oct 8, 2019
Because of their action on the immune system, and due to a lack of available long-term data, a special warning of the potential risk of cancer accompanies the use of recent IS such as cladribine, fingolimod, natalizumab or alemtuzumab...For fingolimod, natalizumab, alemtuzumab, dimethyl fumarate, teriflunomide, daclizumab and ocrelizumab, risk management plans outlined by regulatory agencies are mandatory...We review the current evidence behind the increased risk of malignancy in MS patients receiving DMTs, and provide an overview of the DMTs that are currently in use and those in clinical trials. The known risks and benefits of these therapies will be considered.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Biomarker, Clinical, Review, Journal: Newer Treatment Approaches in Pediatric-Onset Multiple Sclerosis. (Pubmed Central) - Sep 29, 2019 The only FDA- and EMA-approved disease-modifying therapy in POMS is fingolimod; however, dimethyl fumarate, teriflunomide, natalizumab, ocrelizumab, and alemtuzumab either have been evaluated in observational studies or are being currently investigated in formal randomized controlled trials for use in POMS and appear to be safe in this group...Fingolimod is the only FDA-approved medication for use in POMS. Outcome measures and biomarkers used in AOMS are being studied in POMS and are greatly needed to quantify treatment response in this group.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Zinbryta (daclizumab) / Biogen, AbbVie, Rituxan (rituximab) / Roche, Biogen
Clinical, Journal: Use of newer disease-modifying therapies in pediatric multiple sclerosis in the US. (Pubmed Central) - Sep 6, 2019 Newer DMTs are often used in pediatric MS, and have similar short-term safety, tolerability, and side effect profiles as in adults. These findings may help inform pediatric MS management.
- |||||||||| teriflunomide / Generic Mfg., Arzerra (ofatumumab) / Novartis, Genmab
Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials (Hall A) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1622; P3 Baseline demographics and disease characteristics were previously reported (mean age, ~38 years; mean MS duration since first symptom, ~8 years; mean EDSS, 2.9; Gd+ lesions, ~40% of patients). The protocol-defined end of study (EOS) criteria were fulfilled based on blinded data: both ASCLEPIOS studies were powered to 90% for the primary endpoint, and the combined studies to 90% for 3mCDW and to 80% for 6mCDW.
- |||||||||| teriflunomide / Generic Mfg., FTY720, Gilenya (fingolimod) / Novartis, Mitsubishi Tanabe
A Bayesian design to increase the power of multiple sclerosis clinical trials (Hall A) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1387; We took as a working example 3 recent pairs of Phase II-Phase III RCT assessing 3 oral drugs (Dymethil-fumarate (DMF), Teriflunomide (TERI) and Fingolimod (FTY)) in RRMS. The application of Bayesian methods in MS RCT is feasible and should be considered in future trials design, considering the possibility of setting an evidence based prior distribution, as it was the case using the treatment effects on brain MRI lesions at 6 months as a surrogate outcome for annualized relapse rate at 2 years.
- |||||||||| teriflunomide / Generic Mfg.
Pregnancy outcomes in patients treated with leflunomide, an in vivo precursor of the multiple sclerosis drug teriflunomide (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1317; The results of this first large randomized controlled phase 3 study comparing two oral disease-modifying treatments across important clinical and MRI outcomes will help to determine the role of ponesimod, a selective S1P1 functional antagonist, as a potential treatment option in relapsing MS. Current human data do not indicate a teratogenic signal in leflunomide-exposed pregnancies, consistent with data from teriflunomide-exposed pregnancies.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen
Description of the living population with multiple sclerosis in the Danish Multiple Sclerosis Registry (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1161; The DMSR, being population based and with a very high ascertainment of patients, can provide an unselected sample of patients for real-world safety and effectiveness studies. Register linkage also permits various studies on causality, environmental factors and on the social consequences of MS.
- |||||||||| teriflunomide / Generic Mfg.
Teriflunomide protects central nervous system mitochondria during oxidative stress (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1133; In conclusion, we observed that in our model, TFN prevented mitochondrial fragmentation as well as maintained ATP level, oxygen consumption, and neuronal activity during oxidative stress, even though mitochondrial transport and ROS amount were unaffected. Thus, our data demonstrate an undescribed link between TFN, mitochondrial activity and neuroaxonal integrity, and point to a potential neuroprotective effect of DHODH-inhibition in the context of oxidative-stress induced damage of neuronal mitochondria.
- |||||||||| teriflunomide / Generic Mfg.
Effect of teriflunomide in serum urate and phosphate in RMS patients (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1126; After discontinuing treatment SUA levels increase in the first 2 months. Also, teriflunomide decrease phosphate plasma levels, without changing calcium levels, in 100% of patients in the first 12-24 weeks.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Iatrogenesis in multiple sclerosis: what is the therapeutic risk of our disease modifying therapies? (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1125; Current patient exposures for injectable, oral, and infusible MS medications range from 2,000 to over 500,000 while patient years range from 10,000 to over 2.5 million. A comparison of the above (and additional) SAE rates by patient exposure will be presented.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Ocrevus (ocrelizumab) / Roche, Biogen, Rituxan (rituximab) / Roche, Biogen
Real-Life Outcomes of Ocrelizumab Treatment from 3 Multiple Sclerosis Centers in Turkey (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1113; 87,2% of the patients received a previous disease-modifying therapy (DMT) at any time before ocrelizumab treatment and distribution of previous DMT was as follows: Fingolimod in 24,2%, Rituximab in 17,4%, Glatiramer Acetate in 12,8%, Dimethyl Fumarate in 10,5%, Teriflunomide in 9,6%, subcutaneous or intramuscular Interferon Beta-1-A in 13,7%, Natalizumab in 4,1% and other in 6,9%...However, severe disability scores are a limitation for our study, as these patients progress without having any definite clinical relapse over a long time. Ocrelizumab is a well tolerated, safe treatment option for multiple sclerosis patients.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
First Treatment Choices for Relapsing Remitting Multiple Sclerosis: the Italian Registry experience (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1079; Fingolimod (n= 384, 3.6%), Alemtuzumab (n=14, 0.2%)...The highest persistence rates were observed for patients oral DMTs: n=464, 77.8% on Dimethyl fumarate, n=201 (77.1%) on Teriflunomide, n=261, 67.9% on Fingolimod... This large registry study showed that Interferons and Glatiramer acetate remain a valid first therapeutic option for newly diagnosed RRMS patients but also that new oral licensed DMTs showed the highest persistence rates.
- |||||||||| Tecfidera (dimethyl fumarate) / Biogen, Lemtrada (alemtuzumab) / Sanofi
Comparative Effectiveness of Delayed-release Dimethyl Fumarate vs. Other Disease-modifying Therapies in Patients with Multiple Sclerosis: A Network Meta-analysis of Real-world Evidence (Poster Exhibition) - Aug 28, 2019 - Abstract #ECTRIMS2019ECTRIMS_1048; RWE NMAs suggest that, for RRMS pts, DMF is significantly more effective than GA, IFN, and TERI, and comparable to FTY, but not ALEM, and NTZ in reducing ARR and delaying TTFR. This NMA minimised confounding inherent to RWE by selecting robust, adjusted studies.
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