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 as monotherapy for adults with NMOSD.
Article: https://doi.org/10.1016/S1474-4422 (20)30078-8
'The longer-term efficacy in satralizumab monotherapy study reinforces the important role of IL-6 inhibition in treating NMOSD following the previous combination therapy study,' said Chugai's President and COO, Dr.
In the SAkuraStar Study, satralizumab significantly reduced the risk of relapse by 55% (hazard ratio=0.45 [95% confidence interval: 0.23-0.89], p=0.018 [stratified log-rank test]) in the overall population, representative of the broad real-world spectrum of NMOSD patients (including AQP4-IgG seropositive and seronegative patients), achieving the primary endpoint of time to first protocol-defined relapse in the double-blind period. Importantly, 76.1%, 72.1% and 62.8% of patients on satralizumab were relapse-free at weeks 48, 96 and 144 compared to 61.9%, 51.2% and 34.1% with placebo, respectively. In a prespecified subgroup analysis for time to relapse, hazard ratio of satralizumab to placebo in AQP4-IgG seropositive patients was 0.26 (
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 demyelinating lesions of the optic nerve(s), spinal cord and brain1-4. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis5-9.
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 used10.
About satralizumab
Satralizumab, created by Chugai, is an anti-IL-6 receptor recycling antibody. The drug is expected to prevent 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:
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Email: pr@chugai-pharm.co.jp
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