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    Home > Active Ingredient News > Study of Nervous System > Neurology: Natalizumab (natalizumab), the treatment of drug-resistant focal epilepsy, how effective and safe

    Neurology: Natalizumab (natalizumab), the treatment of drug-resistant focal epilepsy, how effective and safe

    • Last Update: 2021-09-29
    • Source: Internet
    • Author: User
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    The main treatment for patients with epilepsy is antiepileptic drugs (ASD), which can balance the excitation and inhibition of neurons
    .


    Approximately 70% of patients can achieve the purpose of controlling seizures after using ASD


    In these patients with epilepsy , surgery, nerve stimulation, special diet and/or other therapies can be used to control seizures


    Blood vessel

    Natalizumab is an anti-α4-integrin monoclonal antibody, approved for the treatment of multiple sclerosis
    .

    In this way, Jacqueline A.
    French of New York University and others hypothesized that by reducing the BBB dysfunction caused by white blood cell-vascular interaction, natalizumab increases the threshold of seizures, thereby reducing the recurrence of epilepsy
    .

    Conversely, the reduction of seizures will reduce the neurogenic inflammation caused by the seizure itself, thereby breaking the cycle of BBB damage, neuroinflammation and seizures
    .

    The reduction of seizures will reduce the neurogenic inflammation caused by the seizure itself, thereby breaking the cycle of BBB injury, neuroinflammation and seizures
    .


    Therefore, in the OPUS study, the effectiveness and safety of natalizumab as an adjuvant therapy for drug-resistant focal epilepsy were systematically explored
    .

    Participants who had ≥6 seizures during the 6-week baseline period were randomized to receive natalizumab 300 mg intravenously or placebo at a 1:1 ratio, once every 4 weeks for 24 weeks
    .


    The main efficacy result is the change in seizure frequency after logarithmic conversion from baseline, and the predetermined treatment success threshold is a 31% reduction in seizure frequency relative to the placebo group


    Among the 32 and 34 participants in the natalizumab 300 mg group and the placebo group, 30 (94%) and 31 (91%) completed the placebo-controlled treatment period (one participant) Randomized to receive natalizumab, but was not injected due to intravenous complications)
    .

    The frequency of seizures of natalizumab relative to placebo is estimated to be -14.
    4% (95% CI -46.
    1% to 36.
    1%, p = 0.
    51)
    .

    The proportion of participants whose seizure frequency was reduced by ≥50% from baseline was 31.
    3% with natalizumab and 17.
    6% with placebo (the odds ratio was 2.
    09, 95% CI was 0.
    64-6.
    85, P = 0.
    22)
    .

    Twenty-four (75%) and 22 (65%) participants who received natalizumab and placebo reported adverse events (AEs)
    .

    The significance of this study is found: Although Ran did not reach the threshold to prove efficacy, but found no unexpected safety, it is necessary to further explore possible anti-inflammatory therapies to treat drug-resistant epilepsy
    .

    Although the threshold for proving curative effects was not reached, there were no accidental safety discoveries,


    Original source:
    French JA, Cole AJ, Faught E, et al.


    Safety and Efficacy of Nataluzimab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study.
     Neurology.


    Safety and Efficacy of Nataluzimab as Adjunctive Therapy for People With Drug-Resistant Epilepsy: A Phase 2 Study.
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