Fumaderm (dimethyl fumarate) / Biogen 
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  • ||||||||||  Fumaderm (dimethyl fumarate) / Biogen
    Biomarker, Journal, Real-world evidence, Real-world:  Evaluating the effect of dimethyl fumarate on subclinical biomarkers in a real-world patient cohort. (Pubmed Central) -  Aug 7, 2024   
    Poor outcomes are predicted in individuals with high baseline risk who are treated with low-efficacy DMTs. Results of this real-world study were consistent with previous DMF phase III clinical trials, supporting the generalizability of the effects observed in clinical trials to the real-world clinical setting.
  • ||||||||||  tofacitinib / Generic mfg.
    A case of cutaneous and osteosarcoidosis successfully treated with Tofacitinib (Poster Area) -  Aug 5, 2024 - Abstract #EADV2024EADV_5126;    
    JAK proteins are associated with cell surface cytokine receptors, and so are early mediators of cell response to inflammation whereby STAT driven transcription is initiated. In sarcoidosis, it is predominantly Type 1 inflammatory cytokines and interferon gamma that bind to JAK associated cytokine receptors1.
  • ||||||||||  Vumerity (diroximel fumarate) / Biogen
    Journal, Lymphopenia:  Lymphopenia is Not the Primary Therapeutic Mechanism of Diroximel Fumarate in Relapsing-Remitting Multiple Sclerosis: Subgroup Analyses of the EVOLVE-MS-1 Study. (Pubmed Central) -  Jun 27, 2024   
    P3
    In DRF-treated patients in EVOLVE-MS-1, clinical and radiological measurements indicated reduced disease activity regardless of lymphopenia or magnitude of ALC decline from baseline; however, patients who had greater ALC declines appeared to have numerically lower ARR and higher proportions free from relapses and gadolinium-enhancing lesions compared with those with smallest decline. This supports prior evidence that, while lymphopenia may contribute to fumarate efficacy outcomes, it is not the primary mechanism of action.
  • ||||||||||  Fumaderm (dimethyl fumarate) / Biogen
    Journal, HEOR, Real-world evidence, Real-world:  Comparative effectiveness of dimethyl fumarate versus non-specific immunosuppressants: Real-world evidence from MSBase. (Pubmed Central) -  May 27, 2024   
    To use MSBase registry data to compare real-world outcomes in adults with relapsing-remitting MS (RRMS) treated with dimethyl fumarate (DMF) or NSIS (azathioprine, cyclosporine, cyclophosphamide, methotrexate, mitoxantrone or mycophenolate mofetil) between January 1, 2014 and April 1, 2022...The DMF cohort experienced longer times to discontinuation (HR: 0.75; p?=?0.001) and CDP (HR: 0.53; p?=?0.001), and shorter time to CDI (HR: 1.99; p?<?0.008), versus the NSIS cohort. This analysis supports the use of DMF to treat patients with relapsing forms of MS, and may have implications for MS practices in countries where NSIS are commonly used to treat RRMS.
  • ||||||||||  Vumerity (diroximel fumarate) / Biogen, Fumaderm (dimethyl fumarate) / Biogen
    Change in Disease Modifying Therapy from DMF to DRF in People with Multiple Sclerosis and the Impact on CD4/CD8 T Cells (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_3938;    
    PwMS who switched from DMF to DRF showed a statistically significant decrease in CD8 T cell count over 1 year of treatment, with the shift becoming evident after 3 months of treatment. Changes in T cell subsets in patients treated with DRF were not associated with an increase in infections.
  • ||||||||||  Vumerity (diroximel fumarate) / Biogen, Fumaderm (dimethyl fumarate) / Biogen
    Real-world Treatment Outcomes in Black, Hispanic, Asian, and White People with Multiple Sclerosis Treated with Fumarates (Colorado Convention Center | Exhibit Hall B-E) -  Mar 8, 2024 - Abstract #AAN2024AAN_2734;    
    Changes in T cell subsets in patients treated with DRF were not associated with an increase in infections. Dimethyl fumarate (DMF) and diroximel fumarate (DRF) are disease-modifying therapies for relapsing MS...Similar FUM efficacy was observed in all racial/ethnic subgroups in this analysis of 2150 racial/ethnic minority pwMS, consistent with prior studies.
  • ||||||||||  Tysabri (natalizumab) / Biogen, Royalty, Fumaderm (dimethyl fumarate) / Biogen
    Journal, HEOR:  Visualizing the target estimand in comparative effectiveness studies with multiple treatments. (Pubmed Central) -  Feb 2, 2024   
    Early initiation of natalizumab produced long-term benefits in relapse outcomes in comparison with BRACETD, regardless of a subsequent escalation in therapy. We showcase how these visualization tools can facilitate the interpretation of target estimands in a case study comparing the effectiveness of teriflunomide (TERI), dimethyl fumarate (DMF)
  • ||||||||||  Tysabri (natalizumab) / Biogen, Royalty
    Journal, HEOR, Cost-effectiveness, Cost effectiveness:  Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom. (Pubmed Central) -  Dec 12, 2023   
    Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD)...Similar cost-effectiveness results were observed across sensitivity analyses. This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.
  • ||||||||||  Vumerity (diroximel fumarate) / Biogen, Fumaderm (dimethyl fumarate) / Biogen
    Review, Journal:  Vaccine response in people with multiple sclerosis treated with fumarates. (Pubmed Central) -  Sep 11, 2023   
    The fumarates, dimethyl fumarate, diroximel fumarate, and monomethyl fumarate, are approved for the treatment of relapsing multiple sclerosis...Additionally, no increase in relapse has been observed in pwMS following vaccination. In pwMS receiving fumarates, vaccination is generally safe and elicits protective immune responses.
  • ||||||||||  Fumaderm (dimethyl fumarate) / Biogen
    A necrobiotic disorder with limited response to numerous systemic therapies (Level 3 - Room 323) -  Apr 24, 2023 - Abstract #WCD2023WCD_696;    
    KEY POINTS: Perforating granuloma annulare is a rare subtype with a prevalence of 5% of granuloma annulare and 80% of patients are younger than 30 years (1). Histologically perforating transepithelial necrobiotic material can be seen and is recognised in perforating granuloma annulare (2), however, this can be difficult to differentiate from other conditions including cutaneous sarcoidosis and mycobacterial infection
  • ||||||||||  Fumaderm (dimethyl fumarate) / Biogen
    Final Analysis of Pregnancy Outcomes Following Exposure to Dimethyl Fumarate in a Prospective International Registry (Both in-person and online) -  Mar 12, 2023 - Abstract #AAN2023AAN_3112;    
    P=N/A
    Overall, 13 (3.6%) infants had adjudicator-confirmed MACDP birth defects and 8 (2.2%) had adjudicator-confirmed EUROCAT birth defects. Conclusions Dimethyl fumarate exposure during pregnancy did not adversely affect pregnancy outcomes, with no increased incidence of birth defects and no increased rate of spontaneous abortion.
  • ||||||||||  dimethyl fumarate / Generic mfg., Fumaderm (dimethyl fumarate) / Biogen
    Clinical, Journal:  Dimethyl fumarate delays multiple sclerosis in radiologically isolated syndrome. (Pubmed Central) -  Mar 2, 2023   
    P4
    This is the first randomized clinical trial demonstrating the benefit of a disease-modifying therapy in preventing a first acute clinical event in people with RIS. ANN NEUROL 2023;93:604-614.
  • ||||||||||  Fumaderm (dimethyl fumarate) / Biogen
    Journal:  Gut Microbiota Changes during Dimethyl Fumarate Treatment in Patients with Multiple Sclerosis. (Pubmed Central) -  Feb 12, 2023   
    In subjects reporting side effects, a higher abundance of Streptococcus, Haemophilus, Clostridium, Lachnospira, Blautia, Subdoligranulum, and Tenericutes and lower of Bacteroidetes, Barnesiella, Odoribacter, Akkermansia, and some Proteobacteria families were detected. Our results suggest that gut microbiota may be involved in therapeutic action and side effects of DMF, representing a potential target for improving disease course and DMT tolerability.
  • ||||||||||  Vumerity (diroximel fumarate) / Biogen
    Real-World Analysis Affirms High Persistence and Adherence with Diroximel Fumarate after Switch from DMF to DRF in MS (B1) -  Jul 18, 2022 - Abstract #EAN2022EAN_2430;    
    These findings substantiated the similar effectiveness and different discontinuation profiles for dimethyl fumarate and fingolimod as a second-line therapy for relapsing-remitting multiple sclerosis, with no significant effect heterogeneity observed. Of 433 patients who switched from DMF to DRF, most (>90%) were able to tolerate and persist on DRF after switching; patients also had a high rate of adherence to DRF, with low treatment discontinuation due to GI AEs.