Roche's Gazyva在治疗狼疮,实现重大试验的关键目标方面取得了显著成果。 Roche's Gazyva showed strong results in treating lupus, meeting key goals in a major trial.

Roche报告说,AllEGORY试验的第三阶段取得了积极结果,表明将Gazyva(Obinutuzumab)纳入标准治疗,大大减少了有系统红喉(SLE)的成年人的疾病活动。 Roche reported positive Phase III results from the ALLEGORY trial, showing that adding Gazyva (obinutuzumab) to standard therapy significantly reduced disease activity in adults with systemic lupus erythematosus (SLE). 该药物达到了主要终点，更多患者在 52 周时 SRI-4 评分提高了 4 分，并且还达到了所有关键的次要终点，包括减少发作和类固醇使用。 The drug met its primary endpoint, with more patients achieving a four-point improvement in the SRI-4 score at 52 weeks, and also met all key secondary endpoints, including reduced flares and steroid use. 没有发现新的安全顾虑。 No new safety concerns were found. 如果得到批准,Gazyva将成为首个专门针对SLE的反CD20疗法,针对的是参与疾病炎症的B细胞。 If approved, Gazyva would be the first anti-CD20 therapy specifically for SLE, targeting B cells involved in disease inflammation. 该公司计划向全球监管者提交数据。 The company plans to submit data to global regulators.