基于一项名为LITHE的国际性随机、双盲、安慰对照Ⅲ期临床试验的阳性数据,罗氏公司的子公司Genentech公司最近获美国FDA批准,拟在其静注类风湿性关节炎药妥利珠单抗(tocilizumab,Actemra)产品标签的用法栏中增加如下内容:本品将与甲氨蝶呤联用治疗中至重度活动性类风湿性关节成年患者,以抑制和减缓关节的结构性损伤,改善身体机能,并达到主要的临床疗效指标。妥利珠单 Genentech, a subsidiary of Roche Inc., was recently approved by the U.S. FDA for its intravenous rheumatoid arthritis drug, based on positive data from an international randomized, double-blind, placebo-controlled phase III trial called LITHE Add the following to the column labeled “Usage of tocilizumab” (Actemra): This product will be used in combination with methotrexate in the treatment of moderate to severe active rheumatoid arthritis in adult patients to inhibit and slow joint structural damage , Improve physical function, and achieve the main clinical indicators of efficacy. Tolli beads