Results from the open label extension periods of SAkuraSky and SAkuraStar support the long-term safety profile of satralizumab in patients with neuromyelitis optica spectrum disorder (NMOSD), according to data presented as a poster at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), held October 25 to 28, 2021 in Orlando, Florida.
Previously, SAkuraSky (satralizumab in combination with baseline immunosuppressant) and SAkuraStar (satralizumab monotherapy) studies have shown that satralizumab is a safe and effective treatment option to reduce relapse risk in patients with NMOSD. The objective of the current study was to determine the long-term safety of satralizumab in patients with NMOSD from the 2 randomized studies.
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Both trials included a double-blind (satralizumab 120 mg every 4 weeks vs placebo) followed by an open label extension (satralizumab only). The overall satralizumab treatment period included all patients who received ≥ 1 dose of satralizumab in the double-blind period or the open-label extension period.
Overall, 41 patients received satralizumab in the double-blind period in the SAkuraSky, and 75 received satralizumab in the double blind or open-label extension (median treatment exposure 205 weeks in the overall satralizumab treatment). In the SAkuraStar, 63 patients received satralizumab in the double blind period and 91 received the treatment in the double-blind or open-label extension (median treatment exposure 157 weeks in the overall satralizumab treatment).
In both studies, the safety profile of satralizumab was similar in the double-blind period and overall satralizumab treatment period.
In SAkuraSky, rates of adverse events were 389.6 events per 100 patient-years, with 11.2 serious adverse events per 100 patients-years in the overall satralizumab treatment periods, comparable to rates reported in the satralizumab and placebo in the double-blind periods. Rates of infections were 130.5 per 100 patients-years, and serious infections were reported at a rate of 3.5 per 100 patient-years with satralizumab in the overall satralizumab treatment period, not higher than with placebo in the double blind period.
In SAkuraStar, rates of adverse events were 403.0 events per 100 patient-years, with 12.2 serious adverse events per 100 patients-years in the overall satralizumab treatment periods, similar to rates reported with the satralizumab and placebo in the double-blind periods. Rates of infections were 89.7 per 100 patients-years, and serious infections were reported at a rate of 3.0 per 100 patient-years with satralizumab in the overall satralizumab treatment period, not higher than with placebo in the double blind period.
No deaths or anaphylactic reactions to satralizumab were reported in either study.
“The favorable safety profile of satralizumab was sustained with long-term treatment,” concluded the researchers.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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Reference
Greenberg BM, de Seze J, Saiz A, et al. Long-term safety of satralizumab in neuromyelitis optica spectrum disorder: results from the open-label extension period of SAkuraSky and SAkuraStar. Presented at: CMSC 2021 Annual Meeting; October 25-28, 2021; Orlando, Florida. Abstract RTH01.
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