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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
.
.
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
.
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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