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Ralf Gold - One of the best experts on this subject based on the ideXlab platform.

  • safety and efficacy of delayed release Dimethyl Fumarate in patients with relapsing remitting multiple sclerosis 9 years follow up of define confirm and endorse
    Therapeutic Advances in Neurological Disorders, 2020
    Co-Authors: Ralf Gold, Ludwig Kappos, Robert J Fox, Amit Baror, Chongshu Chen, Douglas L Arnold, Becky Parks, Catherine Miller
    Abstract:

    Introduction:We report safety and efficacy in patients treated with Dimethyl Fumarate (DMF) for ~9 years in ENDORSE. Lymphocyte analysis data are also reported.Methods:Incidence of serious adverse ...

  • 159 delayed release Dimethyl Fumarate associated lymphopenia
    Journal of Neurology Neurosurgery and Psychiatry, 2019
    Co-Authors: Andrew T Chan, Ralf Gold, Robert J Fox, Amit Baror, Chongshu Chen, Sami Fam, Jerome Hanna, Devangi Mehta, Theodore J Phillips
    Abstract:

    Introduction Following the occurrence of one case of progressive multifocal leukoencephalopathy (PML), the Dimethyl Fumarate (DMF) label was amended in 2015 to recommend treatment interruption for patients with severe, prolonged lymphopenia (SPL, absolute lymphocyte count [ALC] Methods Integrated analysis of DMF phase 2b, phase 3, and extension studies was conducted using data from first DMF exposure. ALCs were assessed 4, 8, and 12 weeks after DMF initiation and every 12 weeks thereafter. Results The analysis population included 2513 patients (DMF exposure up to 11 years). Patients with SPL and those with ALC always above normal had similar incidences of serious infection (0.016 vs 0.010) and herpes zoster (0.000 vs 0.006). One fatal case of PML was associated with SPL (∼3.5 years duration). In patients with mild/moderate lymphopenia and ALC Conclusions These data support previous reports that DMF-associated lymphopenia is not correlated with increased incidence of serious or opportunistic infections. For most patients, ALCs increased within 2 months following DMF discontinuation. Support: Biogen. Disclosures to be included on poster.

  • evidence of activation of the nrf2 pathway in multiple sclerosis patients treated with delayed release Dimethyl Fumarate in the phase 3 define and confirm studies
    Multiple Sclerosis Journal, 2017
    Co-Authors: Sreeja Gopal, Ralf Gold, Robert J Fox, Alvydas Mikulskis, Katherine Dawson, Lakshmi Amaravadi
    Abstract:

    Background:Delayed-release Dimethyl Fumarate (DMF) is an approved oral treatment for relapsing forms of multiple sclerosis (MS). Preclinical studies demonstrated that DMF activated the nuclear fact...

  • sustained effect of delayed release Dimethyl Fumarate in newly diagnosed patients with relapsing remitting multiple sclerosis 6 year interim results from an extension of the define and confirm studies
    Neurology and Therapy, 2016
    Co-Authors: Ralf Gold, Theodore J Phillips, Robert J Fox, Gavin Giovannoni, Annie Zhang, Jing L Marantz
    Abstract:

    Introduction Delayed-release Dimethyl Fumarate (DMF; also known as gastro-resistant DMF) demonstrated clinical and neuroradiologic efficacy and safety in the Phase 3 DEFINE and CONFIRM trials, and in the extension study (ENDORSE), in patients with relapsing–remitting multiple sclerosis (RRMS). This post hoc analysis assessed DMF efficacy in newly diagnosed patients with RRMS with 6-year minimum follow-up.

  • Dimethyl Fumarate ameliorates lewis rat experimental autoimmune neuritis and mediates axonal protection
    PLOS ONE, 2015
    Co-Authors: Kalliopi Pitarokoili, Bjorn Ambrosius, Daniela Meyer, Lisa Schrewe, Ralf Gold
    Abstract:

    BACKGROUND Dimethyl Fumarate is an immunomodulatory and neuroprotective drug, approved recently for the treatment of relapsing-remitting multiple sclerosis. In view of the limited therapeutic options for human acute and chronic polyneuritis, we used the animal model of experimental autoimmune neuritis in the Lewis rat to study the effects of Dimethyl Fumarate on autoimmune inflammation and neuroprotection in the peripheral nervous system. METHODS AND FINDINGS Experimental autoimmune neuritis was induced by immunization with the neuritogenic peptide (amino acids 53-78) of P2 myelin protein. Preventive treatment with Dimethyl Fumarate given at 45 mg/kg twice daily by oral gavage significantly ameliorated clinical neuritis by reducing demyelination and axonal degeneration in the nerve conduction studies. Histology revealed a significantly lower degree of inflammatory infiltrates in the sciatic nerves. In addition, we detected a reduction of early signs of axonal degeneration through a reduction of amyloid precursor protein expressed in axons of the peripheral nerves. This reduction correlated with an increase of nuclear factor (erythroid derived 2)-related factor 2 positive axons, supporting the neuroprotective potential of Dimethyl Fumarate. Furthermore, nuclear factor (erythroid derived 2)-related factor 2 expression in Schwann cells was only rarely detected and there was no increase of Schwann cells death during EAN. CONCLUSIONS We conclude that immunomodulatory and neuroprotective Dimethyl Fumarate may represent an innovative therapeutic option in human autoimmune neuropathies.

Chiara De Fino - One of the best experts on this subject based on the ideXlab platform.

Robert J Fox - One of the best experts on this subject based on the ideXlab platform.

Diego Centonze - One of the best experts on this subject based on the ideXlab platform.

Theodore J Phillips - One of the best experts on this subject based on the ideXlab platform.

  • 159 delayed release Dimethyl Fumarate associated lymphopenia
    Journal of Neurology Neurosurgery and Psychiatry, 2019
    Co-Authors: Andrew T Chan, Ralf Gold, Robert J Fox, Amit Baror, Chongshu Chen, Sami Fam, Jerome Hanna, Devangi Mehta, Theodore J Phillips
    Abstract:

    Introduction Following the occurrence of one case of progressive multifocal leukoencephalopathy (PML), the Dimethyl Fumarate (DMF) label was amended in 2015 to recommend treatment interruption for patients with severe, prolonged lymphopenia (SPL, absolute lymphocyte count [ALC] Methods Integrated analysis of DMF phase 2b, phase 3, and extension studies was conducted using data from first DMF exposure. ALCs were assessed 4, 8, and 12 weeks after DMF initiation and every 12 weeks thereafter. Results The analysis population included 2513 patients (DMF exposure up to 11 years). Patients with SPL and those with ALC always above normal had similar incidences of serious infection (0.016 vs 0.010) and herpes zoster (0.000 vs 0.006). One fatal case of PML was associated with SPL (∼3.5 years duration). In patients with mild/moderate lymphopenia and ALC Conclusions These data support previous reports that DMF-associated lymphopenia is not correlated with increased incidence of serious or opportunistic infections. For most patients, ALCs increased within 2 months following DMF discontinuation. Support: Biogen. Disclosures to be included on poster.

  • sustained effect of delayed release Dimethyl Fumarate in newly diagnosed patients with relapsing remitting multiple sclerosis 6 year interim results from an extension of the define and confirm studies
    Neurology and Therapy, 2016
    Co-Authors: Ralf Gold, Theodore J Phillips, Robert J Fox, Gavin Giovannoni, Annie Zhang, Jing L Marantz
    Abstract:

    Introduction Delayed-release Dimethyl Fumarate (DMF; also known as gastro-resistant DMF) demonstrated clinical and neuroradiologic efficacy and safety in the Phase 3 DEFINE and CONFIRM trials, and in the extension study (ENDORSE), in patients with relapsing–remitting multiple sclerosis (RRMS). This post hoc analysis assessed DMF efficacy in newly diagnosed patients with RRMS with 6-year minimum follow-up.

  • consensus management of gastrointestinal events associated with delayed release Dimethyl Fumarate a delphi study
    Neurology and Therapy, 2015
    Co-Authors: Theodore J Phillips, April A Erwin, Stephanie Agrella, Marcelo Kremenchutzky, John F Kramer, Malcolm J M Darkes, Jonathan Kendter, Heather Abourjaily, Jitesh Rana, Robert J Fox
    Abstract:

    Introduction Delayed-release Dimethyl Fumarate (DMF, also known as gastro-resistant DMF) is indicated for the treatment of patients with relapsing multiple sclerosis. Gastrointestinal (GI) adverse events (AEs) occur with DMF therapy.

  • delayed release Dimethyl Fumarate and pregnancy preclinical studies and pregnancy outcomes from clinical trials and postmarketing experience
    Neurology and Therapy, 2015
    Co-Authors: Ralf Gold, Eva Havrdova, Ludwig Kappos, Theodore J Phillips, Amit Baror, Norman Kim, Tim Thullen, Patricia Valencia, Lauren Oliva, Mark Novas
    Abstract:

    Introduction Delayed-release Dimethyl Fumarate (DMF; also known as gastro-resistant DMF) is an oral agent for the treatment of relapsing forms of multiple sclerosis (MS). No formal studies of DMF were conducted in pregnant women, although pregnancies have occurred during clinical trials and in the postmarketing setting.

  • managing flushing and gastrointestinal events associated with delayed release Dimethyl Fumarate experiences of an international panel
    Multiple sclerosis and related disorders, 2014
    Co-Authors: Theodore J Phillips, Ralf Gold, Robert J Fox, Michael Hutchinson, Eva Havrdova
    Abstract:

    Strategies for monitoring and managing the known adverse event (AE) profile of therapies for relapsing–remitting multiple sclerosis have become key to the optimization of patient outcomes. Delayed-release Dimethyl Fumarate (DMF) was associated with an increased risk of flushing and gastrointestinal (GI) AEs in clinical trials. A survey of clinicians with significant research experience using delayed-release DMF was conducted to provide guidance to clinicians using delayed-release DMF in clinical practice on the management of flushing and GI tolerability AEs. Recommendations for prophylaxis included educating the patient about flushing and GI AEs associated with delayedrelease DMF and recommending administration with food. A variety of symptomatic treatments were utilized during the delayed-release DMF clinical trials in patients presenting with delayedrelease DMF–related flushing or GI AEs that were severe or bothersome enough to warrant pharmacological intervention.