Satralizumab reduces relapse frequency in neuromyelitis optica spectrum disorder
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Satralizumab may be an effective option to reduce the frequency of relapse in patients with neuromyelitis optica spectrum disorder, an autoimmune disease leading to inflammatory demyelinating lesions of the spinal cord and optic nerves. Analyses of the phase 3 SAkuraSky and SAkuraStar studies seem promising, according to one presenter at the virtual Association for Research in Vision and Ophthalmology meeting.
“NMOSD is a debilitating disease of the central nervous system. Patients experience unpredictable relapses causing cumulative permanent neurological damage and disability. In some cases, relapses can result in death,” Zdenka Haskova, MD, said.
Because neuromyelitis optica spectrum disorder (NMOSD) typically progresses through frequent relapses, leading to incremental disability, disease management focuses on preventing or delaying frequent attacks. Satralizumab is a humanized monoclonal antibody targeting the IL-6 receptor, a key element of NMOSD pathophysiology. IL-6 triggers the inflammatory cascade that leads to damage and disability thorough activation of B and T cells, astrocyte damage and breakdown of the blood-brain barrier within the central nervous system.
The SAkuraSky and SAkuraStar studies investigated the efficacy of satralizumab in combination with baseline immunosuppressive therapy and as monotherapy, respectively. A total of 178 patients were included, 104 on satralizumab and 74 on placebo. The age of the patients ranged between 13 and 73 years. Satralizumab 120 mg was injected subcutaneously every 4 weeks.
“Satralizumab, as monotherapy or in combination, significantly reduced the frequency of relapses. In the pooled analysis, the proportion of relapse-free patients at 48 weeks was 81% for satralizumab and 64% for placebo. These figures at 96 weeks were 74% and 55%. Overall, patients on satralizumab had a relative risk reduction of 58% vs. placebo,” Haskova said.
Subgroup analysis showed that the drug was especially effective in aquaporin-4 immunoglobulin G seropositive patients, both at 48 and 96 weeks. The safety profile was favorable, with no major adverse events, and a proportion of minor adverse events similar to placebo.
“Satralizumab has the potential to become a valuable treatment option for these patients,” Haskova said. – by Michela Cimberle
Reference:
Haskova Z, et al. Efficacy and safety of satralizumab from two phase 3 trials in neuromyelitis optica spectrum disorder. Presented at: Association for Research in Vision and Ophthalmology annual meeting; May 6, 2020 (virtual meeting).
Disclosure: Haskova reports she is an employee of Genentech.