Lancet Neurology: The safety and effectiveness of Satralizumab's single-drug treatment for optic neurospinal cord disease spectrum disorder: a randomized, double-blind, multi-center, placebo-controlled Phase 3 trial

Optic neuroscolonitis spectrum disorder (NMOSD) is an autoimmune neurological disease with a global incidence estimated at 182 per 100,000 people.
the disease is characterized by inflammatory lesions of the optic nerve, spinal cord, brain trunk and brain that can lead to severe movement and sensory disorders, bladder dysfunction, loss of vision, pain and other debilitating symptoms.
the disease is variable, and inflammation attacks can often lead to permanent disability.
interlethocytosin-6 (IL-6) is thought to play a key role in the disease activity of NMOSD.
IL-6 promotes the differentiation of primitive T cells into inflammatory auxiliary T cells 17, and the presence of IL-6 further stimulates the differentiation of B cells into plasma cells that produce AQP4-IgG.
IL-6 also increases the permeability of the blood-brain barrier, which causes AQP4-IgG and inflammatory cells to enter the central nervous system (CNS).
in CNS, il-6 secreted by active asberic glial cells may directly damage less protrusive glial cells and axons, promoting demyelination and neurologic defects.
il-6 also regulates the expression of complement C3, which is the ingredient necessary for complement path activation.
levels of serum and cerebrospinal fluid IL-6 increased during and after recurrence, associated with increased instability after recurrence, and associated with cerebrospinal fluid AQP4-IgG titration.
Satralizumab is a human-based monoclonal antibody injected under the skin that binds to a soluble IL-6 subject that binds to the membrane, blocking the binding of IL-6's inflammation-related IL-6 signaling path.
study is a Phase 3 randomized trial (SAkuraStar) that evaluates the safety and effectiveness of satralizumab monotherapy and placebo therapy for adult NMOSD patients.
study recruited adults aged 18-74, serotonin-positive or serum-negative NMOSD from 44 sites in 13 countries.
eligible participants had experienced at least one NMOSD seizure or relapse in the past 12 months and scored 6.5 points or less on the extended disability scale.
exclusion criteria include clinical recurrence 30 days or less before the baseline.
participants were randomly assigned (2:1) to be injected with 120 mg of satralizumab or matching placebo every 4 weeks after week 0, 2, 4 weeks and were prohibited from taking immunosuppressants at the same time.
endpoint is the recurrence time defined by the first programme, which is layered based on the intentional treatment of the population and the stratization of two random factors (the treatment of previously prevented seizures and the nature of recent seizures).
between 5 August 2014 and 2 April 2017, 95 (57%) of the 168 subjects were randomly assigned to the treatment group (63 taking satralizumab and 32 taking a placebo).
19 patients (30%) who received satralizumab and 16 (50%) patients who received a placebo had a relapse as defined by the program (risk ratio 0.45, 95% CI 0.23-0.89; p=0.018).
473.9 adverse events per 100 patients in the Satralizumab group and 495.2 cases/100 patient years in the placebo group.
adverse events between the two groups and the rates of adverse events that led to drug suspension were similar between the two groups.
, the use of satralizumab monotherapy in patients with NMOSD delayed and reduced recurrence rates, especially in patients with AQP4-IgG seroposes.
these positive results, satralizumab has the potential to be a valuable treatment option for NMOSD patients.
Traboulsee, Anthony et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. The Lancet Neurology, Volume 19, Issue 5, 402 - 412MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce, and any media, website or individual must indicate "Source: Mays Medical".
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