CHUGAI PHARMACEUTICAL CO., LTD Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The phase III study examined the efficacy and safety of satralizumab added to baseline therapy in patients with NMOSD.
'Relapses of NMOSD may lead to accumulation of disabilities and can be life-threatening. These data further reinforce the importance of IL-6 signal inhibition in treating NMOSD,' said Dr.
In SAkuraSky Study, only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR) compared to 18 of 42 patients (43%) treated with placebo in combination withbaseline therapy (HR=0.38, 95% CI: 0.16-0.88; p=0.02 [stratified log-rank test]) in the overall population, representative of NMOSD patients (including anti-AQP4-IgG antibody seropositive and seronegative patients). Importantly, 89%, 78% and 74% of patients on satralizumab in combination with baseline therapy were relapse-free at weeks 48, 96 and 144 compared to 66%, 59% and 49% with placebo in combination with baseline therapy. The proportion of serious adverse events was similar between the satralizumab and placebo treatment groups.
About neuromyelitis optica spectrum disorder (NMOSD)
NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and cause continual and significant decrease in quality of life due to permanent neurologic disorders Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, and loss of quality of life. In some cases, attacks of NMOSD result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in at least two-thirds of NMOSD patients. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain 1-4. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 5-9.
Diagnostic criteria introduced in 2006 for NMO were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD further revised to include a broader spectrum of disease. The diagnostic term NMOSD is now widely used 10.
About satralizumab
Satralizumab, created by Chugai, is an anti-IL-6 receptor recycling antibody. The drug is expected to suppress relapse of NMOSD by inhibiting IL-6 signal transduction which is deeply related to the pathology. In two global phase III clinical studies in NMO and NMOSD patients, the primary endpoint was achieved with satralizumab either as an add-on therapy to baseline immunosuppressant treatment (NCT02028884) or as monotherapy (NCT02073279). These studies represent one of the largest clinical trial programs undertaken for this rare disease. Satralizumab is designated as an orphan drug for the treatment of NMO and NMOSD in
Contact:
Tel: +81-3-3273-0881
Email: pr@chugai-pharm.co.jp
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