Bristol Myers Squibb Presents Data For Multiple Sclerosis Drug Zeposia, Shows Long-Term Efficacy
Bristol Myers Squibb Presents Data For Multiple Sclerosis Drug Zeposia, Shows Long-Term Efficacy
Additionally, findings from a separate Daybreak OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events (TEAEs), with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.Wednesday, Bristol Myers Squibb & Co (NYSE:BMY) announced new data from the Phase 3 Daybreak trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia (ozanimod) for relapsing forms of multiple sclerosis.
週三，百威斯康辛大型製藥公司（紐交所：BMY）宣佈，來自第3期黎明試驗的新數據顯示，接受Zeposia（奧扎尼莫德）治療復發型多發性硬化症患者在開放標籤延長（OLE）期間大腦體積損失率持續降低。
These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60 (annualized least squares mean [LSM] % change from parent trial baseline: Radiance, −0.27; Sunbeam, −0.35).
這些研究結果表明，接受連續Zeposia治療長達五年的患者在60個月內經歷了低而穩定的全腦體積（WBV）損失率（從父試驗基線算出的年化最小二乘均值[LSM]變化率分別爲：Radiance，−0.27；Sunbeam，−0.35）。
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Additionally, findings from a separate Daybreak OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events (TEAEs), with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.
此外，分開的黎明OLE安全性分析結果顯示，患者出現治療後不良事件（TEAEs）的發病率呈下降或穩定趨勢，感染、嚴重感染和機會性感染的發病率在接受Zeposia治療八年多的期間相對較低。
These will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
這些研究結果將在第40屆歐洲多發性硬化症治療與研究委員會大會上報告。
The Daybreak OLE trial included 2,257 patients from the Sunbeam and Radiance Phase 3 trials and evaluated rates of brain volume loss.
黎明OLE試驗納入了來自Sunbeam和Radiance第3期試驗的2257名患者，並評估了大腦體積損失率。
Switching from interferon beta-1a (IFN-β) to Zeposia treatment consistently reduced rates of WBV loss (annualized LSM% change from Radiance baseline to Month 24 and Daybreak baseline to Month 24: −0.48 and −0.19, respectively, with a similar pattern observed in Sunbeam).
從干擾素β-1a（IFN-β）轉換爲Zeposia治療持續降低了WBV損失率（從Radiance基線到第24個月和Daybreak基線到第24個月的年化最小二乘均值變化率分別爲：−0.48和−0.19，Sunbeam中觀察到類似的趨勢）。
Additionally, similar reductions were observed for changes in thalamic volume loss.
此外，觀察到丘腦體積損失的改變也有類似的減少。
High annualized LSM% reductions in cortical grey matter volume (CGMV) were observed with IFN-β (annualized change at Month 12 relative to Sunbeam baseline: −1.02; annualized change at Month 24 relative to RADIANCE baseline: −0.59), but this trend reversed 12 months after switching to Zeposia in Daybreak (annualized LSM% increase relative to Daybreak baseline: patients from Sunbeam, 0.10; patients from Radiance, 0.20), with low annualized LSM% CGMV loss observed after that.
觀察到使用IFN-β後，頂葉灰質體積（CGMV）出現高年化減少（與Sunbeam基線相比，12個月內年化變化爲-1.02；與RADIANCE基線相比，24個月內年化變化爲-0.59），但在轉換到Zeposia的Daybreak之後的12個月內，這種趨勢逆轉（與Daybreak基線相比的年化LSM%增加：來自Sunbeam的患者爲0.10，來自Radiance的患者爲0.20），之後觀察到低年化LSM% CGMV損失。
Price Action: BMY stock is up 0.40% at $49.69 during the premarket session at last check Wednesday.
價格行情：BMY股票在週三盤前交易中上漲0.40%，至49.69美元。
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譯文內容由第三人軟體翻譯。
