Satralizumab well tolerated in treatment of neuromyelitis optica spectrum disorder
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Pooled study data showed satralizumab for the treatment of neuromyelitis optica spectrum disorder was well tolerated as monotherapy or in combination with immunosuppressive therapy, according to a press release.
The pooled data from the double-masked periods of the SAkuraStar and SAkuraSky phase 3 studies, presented virtually at the European Academy of Neurology meeting, showed rates of adverse events and serious adverse events were comparable between satralizumab and placebo groups when satralizumab was used as monotherapy or in combination with baseline immunosuppressive therapy. Additionally, the safety profile of satralizumab in the double-masked period of the studies was consistent with its open-label extension regarding the nature and rate of adverse events.
A separate analysis of the SAkuraSky study found eight adolescents treated with satralizumab experienced a consistent benefit-risk profile when compared with an adult population. Adolescents were treated with the same adult dosing regimen of satralizumab 120 mg or placebo with baseline therapy at weeks 0, 2 and 4 and then every 4 weeks.
Additionally, based on pharmacokinetic and pharmacodynamic analyses from phase 1 and the two phase 3 studies, data showed significant sustained interleukin-6 (IL-6) signaling inhibition with a once every 4 weeks dosing regimen of 120 mg satralizumab. For patients with NMOSD, a 120 mg dose of satralizumab allowed for more than 95% binding to the IL-6 receptor over the 4-week period.
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