- |||||||||| Leustatin (cladribine) / J&J
Journal: MSCOVID19: Using social media to achieve rapid dissemination of health information. (Pubmed Central) - Nov 2, 2020
The cases shared present the earliest reported data on outcomes of COVID-19 infection in pwMS. Whilst limited, the cautiously reassuring nature of these early cases assisted in clinical management by allowing neurologists to continuously reassess their approach to DMT management.
- |||||||||| Leustatin (cladribine) / J&J, Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Effects of MS disease-modifying therapies on responses to vaccinations: A review. (Pubmed Central) - Nov 1, 2020
Responses to any vaccination depend on the vaccine type, the type of response (recall versus response to a novel antigen), and the impact of the individual disease-modifying therapy on humoral and cellular immunity in response to that vaccine type. When considering a given therapy, clinicians should weigh its efficacy against MS for the individual patient versus potential impact on responses to vaccinations that may be needed in the future.
- |||||||||| dimethyl fumarate / Generic mfg., carbamazepine / Generic mfg.
Clinical, Journal, Lymphopenia: Risk factors for lymphopenia in patients with relapsing-remitting multiple sclerosis treated with dimethyl fumarate. (Pubmed Central) - Oct 27, 2020
Patients with low baseline lymphocyte counts, with intermediate BMI, with white ethnicity, with advanced age, or with no tobacco use, had a significantly higher incidence of lymphopenia on DMF. Intermediate BMI or lowest quartile baseline ALC predicted low CD4 levels, while advanced age or white ethnicity predicted low CD8 levels from DMF exposure.
- |||||||||| Vumerity (diroximel fumarate) / Biogen
Journal: Diroximel fumarate to treat multiple sclerosis. (Pubmed Central) - Oct 27, 2020
For DRF, one phase III study has been completed, and another is in progress to determine its safety, tolerability and efficacy. In this paper, we review the pharmacology, pharmacokinetics, metabolism, clinical studies and drug safety of DRF.
- |||||||||| dimethyl fumarate / Generic mfg.
Journal: Cannabinoid CB Receptor Modulation by the Transcription Factor NRF2 is Specific in Microglial Cells. (Pubmed Central) - Oct 25, 2020
These results are related to the differential levels of expression of both genes regarding the brain cell type. Since modulation of CB receptor signaling may represent a promising therapeutic target with minimal psychotropic effects that can be used to modulate endocannabinoid-based therapeutic approaches and to reduce neurodegeneration, our findings will contribute to disclose the potential of CB as a novel target for treating different pathologies.
- |||||||||| dimethyl fumarate / Generic mfg.
Retrospective data, Review, Journal, HEOR, Real-World Evidence: Real-world adherence to, and persistence with, once- and twice-daily oral disease-modifying drugs in patients with multiple sclerosis: a systematic review and meta-analysis. (Pubmed Central) - Oct 24, 2020
Opportunities to improve adherence and ultimately patient outcomes, such as patient education, medication support/reminders, simplified dosing regimens, and reducing administration or monitoring requirements, remain. Implementation of efforts to improve adherence are essential to improving care of patients with MS.
- |||||||||| Leustatin (cladribine) / J&J, Lemtrada (alemtuzumab) / Sanofi
Review, Journal: Immunological Aspects of Approved MS Therapeutics. (Pubmed Central) - Oct 22, 2020
Currently, more than a dozen drugs representing 1 substances with different mechanisms of action have been approved (interferon beta preparations, glatiramer acetate, fingolimod, siponimod, mitoxantrone, teriflunomide, dimethyl fumarate, cladribine, alemtuzumab, ocrelizumab, and natalizumab)...The objective of this review is to present the modes of action of these drugs and their effects on the immunopathogenesis of MS. Each agent's clinical development and potential side effects are discussed.
- |||||||||| dimethyl fumarate / Generic mfg.
Review, Journal: Drugs for Multiple Sclerosis Activate Natural Killer Cells: Do They Protect Against COVID-19 Infection? (Pubmed Central) - Oct 20, 2020
Several drugs, including glatiramer acetate (GA), vitamin D, dimethyl fumarate (DMF), monomethyl fumarate (MMF), natalizumab, ocrelizumab, and IFN-β, among others have been previously described to increase the biological activities of NK cells especially their cytolytic potential as reported by upregulation of CD107a, and the release of perforin and granzymes. In this review, we propose that such drugs could potentially restore NK cell activity allowing individuals to be more protective against COVID-19 infection and its complications.
- |||||||||| dimethyl fumarate / Generic mfg.
Clinical, Review, Journal: Dimethyl Fumarate and Its Esters: A Drug with Broad Clinical Utility? (Pubmed Central) - Oct 20, 2020
DMF, as well as monomethyl fumarate and diroximel fumarate, are commonly prescribed first-line agents with favourable safety and efficacy profiles. The potential benefits of FAEs against other diseases that appear pathogenically different but share the pathologies of oxidative stress and inflammation are currently investigated.
- |||||||||| glatiramer acetate / Generic mfg., dimethyl fumarate / Generic mfg., teriflunomide / Generic mfg.
Enrollment open, Trial initiation date, HEOR, Cost effectiveness: Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). (clinicaltrials.gov) - Oct 19, 2020
P=N/A, N=130, Recruiting,
The potential benefits of FAEs against other diseases that appear pathogenically different but share the pathologies of oxidative stress and inflammation are currently investigated. Not yet recruiting --> Recruiting | Initiation date: Feb 2020 --> Jul 2020
- |||||||||| dimethyl fumarate / Generic mfg.
Journal: Novel CMKLR1 Inhibitors for Application in Demyelinating Disease. (Pubmed Central) - Oct 16, 2020
Here we directly compared α-NETA versus FDA-approved MS drug Tecfidera for clinical efficacy in EAE; characterized key safety/toxicity parameters for α-NETA; identified structure-activity relationships among α-NETA domains and CMKLR1 inhibition; and evaluated improved α-NETA analogs for in vivo efficacy...In addition, we discovered structurally differentiated α-NETA analogs (primarily ortho- or para-methoxy substitutions) with significantly improved target potency in vitro and improved efficacy in vivo. These findings suggest that α-NETA-based CMKLR1 inhibitors may prove safe and effective in treating demyelinating diseases and potentially other autoimmune disorders.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal, Real-World Evidence: Real-world effectiveness of initial disease-modifying therapies in pediatric MS. (Pubmed Central) - Oct 15, 2020
Initial treatment of pediatric MS/CIS with newer DMTs led to better disease activity control compared to injectables, supporting greater effectiveness of newer therapies. Long-term safety data for newer DMTs are required.
- |||||||||| dimethyl fumarate / Generic mfg.
Enrollment closed: ESTEEM: Dimethyl Fumarate (DMF) Observational Study (clinicaltrials.gov) - Oct 13, 2020
P=N/A, N=5496, Active, not recruiting,
In conclusion, NRF2 agonists 4-OI and DMF induce a distinct IFN-independent antiviral program that is broadly effective in limiting virus replication and in suppressing the pro-inflammatory responses of human pathogenic viruses, including SARS-CoV2. Recruiting --> Active, not recruiting
- |||||||||| dimethyl fumarate / Generic mfg., Ocrevus (ocrelizumab) / Roche, Biogen
[VIRTUAL] Multiple Sclerosis in Portugal - Clinical and Economic IMPACT of Ocrelizumab () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1845;
METHODS Previously validated discrete-time Markov models for MS were adapted to model the impact of ocrelizumab versus current clinical practise across three populations: treatment naïve RRMS (versus IFNB-1a, dimethyl fumarate, glatiramer acetate and teriflunomide), treatment experienced RRMS (versus fingolimod, natalizumab) and PPMS (versus best supportive care)...Subpopulation analysis demonstrates a higher effectiveness for the treatment of naïve RRMS patients (1.05 incremental QALY) and a dominant (cost-saving) scenario for experienced RRMS patients. CONCLUSIONS Ocrelizumab has demonstrated to be an efficient alternative for the treatment of MS in Portugal, being expected to provide a clear clinical benefit and overall savings for the National Health Service.
- |||||||||| [VIRTUAL] Rwe Use of Cladribine Tablets in Portugal- Snapshot of a Cohort Database () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1505;
Characterization of RWE data is possible and should be pursued in order to properly verify real world outcomes. Further analysis should be carried-out over time to properly characterize this patient population and the long-term outcomes resulting from this specific treatment option, such as the time on treatment.
- |||||||||| [VIRTUAL] Socioeconomic Value of Ocrelizumab in the Treatment of Patients with Relapsing Forms of Multiple Sclerosis () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1443;
We assessed benefits derived from the use of ocrelizumab in RMS in the UK from a socioeconomic perspective, using dimethyl fumarate, natalizumab and cladribine as comparators...CONCLUSIONS : Ocrelizumab for RMS offers substantial socioeconomic benefits versus relevant first- and second-line DMTs in the UK. Starting high-efficacy DMTs early in treatment could be of value to patients with RMS, caregivers, and healthcare systems.
- |||||||||| [VIRTUAL] Cladribine Tablets (CT) Versus Other Disease-Modifying Therapies in the Treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) - Cost-Effectiveness Analysis. () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1255;
OBJECTIVES To assess the cost-effectiveness of CT (Mavenclad®) as a treatment of high disease activity (HDA) RRMS, compared with alternative 1st line therapies in Poland: interferon beta-1a (IFN-b1a), interferon beta-1b (IFN-b1b), peginterferon beta-1a (pegIFN), dimethyl fumarate (DMF), glatiramer acetate (GA) and teriflunomide (TER)...CONCLUSIONS CT appears as cost-effective MS therapy in Poland, offering good value for money in the Polish healthcare system. Therefore the recent positive reimbursement decision for Mavenclad® issued for restricted population should be reconsidered in the future, so that more patients with HDA RRMS could benefit from CT use, that is firmly grounded in clinical evidence and supported by the financial estimates.
- |||||||||| [VIRTUAL] Optimal Treatment Sequence for Relapsing Remitting Multiple Sclerosis- Results from a Health Economic Modelling Study () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1168;
Sequences were limited to treatments in the Dutch MS clinical guidelines with first line (interferons, glatiramer acetate, dimethyl fumarate and teriflunomide), second line (fingolimod, ocrelizumab, cladribine and natalizumab) and third line (alemtuzumab)...Treatments that were dominated in the fully incremental analysis ranked high in a net health benefit analysis. Limitations of the study include the lack of treatment effect on imaging results, which are an important driver in clinical decision making, and issues inherent to the use of NMA, such as confounders due to trial design.
- |||||||||| dimethyl fumarate / Generic mfg., teriflunomide / Generic mfg., Fumaderm (dimethyl fumarate) / Biogen
[VIRTUAL] Cost-Effectiveness of Dimethyl-Fumarate Compared to Teriflunomide for Relapsing Remitting Multiple Sclerosis Patients in Italy () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_592;
Limitations of the study include the lack of treatment effect on imaging results, which are an important driver in clinical decision making, and issues inherent to the use of NMA, such as confounders due to trial design. Dimethyl-fumarate is cost-effective or dominant (more effective and less costly) vs teriflunomide for the first-line treatment of relapsing-remitting multiple sclerosis in Italian setting.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] Cost-Consequence Analysis of Dimethyl Fumarate Versus Other Disease-Modifying Therapies in Multiple Sclerosis- A French Cohort Study with Snds National Claims Database in France () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_468;
OBJECTIVES Recently, dimethyl fumarate (DMF) was added to the therapeutic arsenal against Multiple Sclerosis (MS), but the cost-consequence of this drug versus other first-line disease-modifying therapies (i.e. injectable immunomodulatory drugs (IID) and two other oral drugs: fingolimod (FTY) and teriflunomide (TERI)) has never been studied in real world settings using data of a national claims database METHODS A cost–consequence analysis was performed for all patients identified in the French national claims database (SNDS), who initiated DMF, IID, TERI or FTY between 2015 and 2017, with 1 to 3.5 years of follow-up...In comparison to FTY, overall costs were significantly lower for DMF (15575€ vs. 24206€). CONCLUSIONS Compared to TERI and IID, DMF is an effective treatment strategy in reducing relapse occurrence in MS patients, which nevertheless entails an additional cost for the French healthcare system.
- |||||||||| dimethyl fumarate / Generic mfg., Fumaderm (dimethyl fumarate) / Biogen
[VIRTUAL] Estimating the Fiscal Consequences of Investments in Disease-Modifying Therapies for the Treatment of Relapsing-Remitting Multiple Sclerosis in Italy () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_291;
This study explores the value of public investments for two well-established disease-modifying therapies (DMTs) in MS from a fiscal perspective in Italy: delayed-release dimethyl-fumarate and natalizumab...The fiscal modeling framework described here shows a considerable offset of public investments in the DMTs that is not captured in classical cost-effectiveness or budget-impact analyses. Furthermore, it illustrates that a broader “government perspective” cost analysis reveals additional cost-savings that extend beyond the health service that can be used to inform allocation decisions as well as to support an appropriate level of funding for DMTs in Italy.
- |||||||||| dimethyl fumarate / Generic mfg., Ocrevus (ocrelizumab) / Roche, Biogen, Lemtrada (alemtuzumab) / Sanofi
Journal: Highly active RRMS and ocrelizumab after failure of alemtuzumab therapy. (Pubmed Central) - Sep 30, 2020
Furthermore, it illustrates that a broader “government perspective” cost analysis reveals additional cost-savings that extend beyond the health service that can be used to inform allocation decisions as well as to support an appropriate level of funding for DMTs in Italy. Thus, when the alemtuzumab treatment is unsuccessful, the authors recommend testing T- and B-cell levels and proceeding with an early switch to ocrelizumab if high B-cell counts are found.
- |||||||||| dimethyl fumarate / Generic mfg.
Clinical, Journal: Hepatitis E virus infections in patients with MS on oral disease-modifying treatment. (Pubmed Central) - Sep 26, 2020
Our data do not suggest an increased incidence of acute HEV infections or chronification in pwMS. However, epidemiologic studies in immunomodulatory-treated patients are needed to further investigate HEV disease courses and extrahepatic manifestations.
- |||||||||| dimethyl fumarate / Generic mfg.
Journal: Treatment with Dimethyl Fumarate Enhances Cholinergic Transmission in Multiple Sclerosis. (Pubmed Central) - Sep 23, 2020
However, epidemiologic studies in immunomodulatory-treated patients are needed to further investigate HEV disease courses and extrahepatic manifestations. Treatment of MS patients with DMF results in increased cholinergic stimulation, with possible implications for neuroinflammation and neuroprotection.
- |||||||||| dimethyl fumarate / Generic mfg.
Journal: An evaluation of dimethyl fumarate for the treatment of relapsing remitting multiple sclerosis. (Pubmed Central) - Sep 20, 2020
However, long-term follow up studies are needed to provide further data on progressive multifocal leukoencephalopathy (PML) risk stratification for MS patients on treatment with DMF. Indeed, despite the strong association with lymphopenia, not all patients with DMF associated PML experienced prolonged overall lymphopenia, suggesting that additional predictive metrics are still needed.
- |||||||||| dimethyl fumarate / Generic mfg.
[VIRTUAL] The Truth Behind the Transaminitis () - Sep 15, 2020 - Abstract #ACG2020ACG_2714;
Though the patient had a remote history of sarcoidosis, she also had a number of other possible causes for her transaminitis and prior to the second biopsy, the working diagnosis of autoimmune hepatitis was supported by a positive ANA and improvement following steroids. This case highlights the importance of keeping a broad, evolving differential while merging clinical assessment with critical interpretation of laboratory data.
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