Express . . . For the treatment of rare immune diseases, Roche IL-6 antibodies were treated with long-term safety data.
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Last Update: 2020-07-21
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Source: Internet
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Author: User
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Today, Genentech, a Roche company, released long-term safety data on its IL-6 antibody satralizumab in the treatment of adult and adolescent patients with neuromyelitis optica spectrum disorder (nmosd).data from two key phase 3 clinical studies show that satralizumab alone or in combination with immunosuppressants is safe and well tolerated in patients with nmosd.nmosd is a rare autoimmune disease of the central nervous system (CNS), which affects hundreds of thousands of people worldwide.the main symptoms of the patients were inflammatory lesions of the optic nerve and spinal cord.nmosd patients often have disease recurrence, and repeated attacks of immune system on their own tissues will lead to gradual accumulation of nerve damage and disability.patients will suffer from visual acuity, motor function and quality of life, and severe nmosd episodes can lead to death.at present, there is no approved treatment for this disease.in recent years, proinflammatory cytokine IL-6 is an emerging and important target in the pathogenesis of nmosd, which triggers the inflammatory cascade, leading to injury and disability.satralizumab developed by Roche is a completely humanized monoclonal antibody against IL-6.it can inhibit the IL-6 signaling pathway, and inhibit the production of inflammation and the production of autoimmune antibodies targeting AQP4.satralizumab is subcutaneously injected once every four weeks, which is a convenient treatment option for patients and nursing staff.previously, the US FDA granted the breakthrough therapy accreditation.its application for a biological product license to treat nmosd is currently under FDA review and is expected to receive a response this summer.} introduction to satralizumab (photo source: reference [2]) the pooled data from double-blind phase trials of phase 3 studies named sakurastar and sakurasky showed that the incidence of adverse events (AE) and serious adverse events (SAE) of satralizumab as monotherapy or combined with baseline therapy was comparable to that of placebo group.in the open label extended period (OLE), the safety characteristics of satralizumab were consistent with those of double-blind period.there was no change in the incidence, rate or type of infection.in a separate analysis of the sakurasky study, adolescent patients treated with the same dose and frequency of satralizumab showed substantially the same benefit and risk characteristics as adult patients. "the open label extended data of the phase 3 study confirmed the safety of satralizumab and observed its good tolerance and potential for the treatment of this chronic disease," said Jerome de. from the center for neurology and clinical research at the University of Strasbourg, France "Despite recent significant advances in the study of nmosd, patients with nmosd still need more approved treatment options to provide them with well tolerated, safe and effective therapies," Professor Seze said. "reference: [1] new long term data reinforcement safety of Genentech's satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder (nmosd). Retrieved 2020-05-22, from's-satralizumab [2] Roche Pharma day 2019. Retrieved 2020-05-22, Note: the purpose of this article is to introduce the progress of medical and health research, not to recommend treatment options. if you need guidance on treatment plan, please go to a regular hospital.
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