TNF阻断剂Simponi获准用于溃疡性结肠炎患者

圣路易斯(MD Consult)——2013年5月15日，杨森生物技术公司宣布，美国食品药品管理局(FDA)已批准Simponi(戈利木单抗)用于已证实对皮质类固醇依赖或对口服氨基水杨酸、口服类固醇皮质激素、咪唑硫嘌呤或6-巯基嘌呤无充分应答或不能耐受的中至重度活动性溃疡性结肠炎(UC)患者的治疗。Simponi属于抗-肿瘤坏死因子(TNF)-α药物，此前已被批准用于治疗类风湿性关节炎、银屑病性关节炎和强直性脊柱炎。

这次获批得到来自针对传统药物治疗无应答或不能耐受的中至重度活动性UC患者评价临床试验数据的支持。与安慰剂组相比， 200 mg/100 mg Simponi治疗组6周时达到临床应答、临床缓解和黏膜内镜表现改善的患者比例显著较高。54周时100 mg Simponi治疗组患者仍维持临床应答的患者比例也明显高于安慰剂组。在接受Simponi诱导治疗后，30周和54周时仍呈现临床缓解、54周内任何时间点未显示失去应答的临床应答患者比例，100 mg Simponi治疗组也显著高于安慰剂组。

在UC试验中观察到的Simponi安全性结果与其用于风湿性适应证的已知安全性一致。与应用TNF-阻断剂相关的不良事件包括感染和某些癌症风险增加。

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ST LOUIS (MD Consult) - On May 15, 2013, Janssen Biotech announced that the US Food and Drug Administration (FDA) has approved Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have shown an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Simponi is an anti-tumor necrosis factor (TNF)-alpha therapy. It has been previously approved for use in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

The approval is supported by data from a program of clinical trials that evaluated patients with moderately to severely active UC who had previously failed to respond to or were intolerant to conventional treatments. Significantly greater proportions of patients who received Simponi 200 mg/100 mg achieved clinical response, clinical remission, and improvement of the endoscopic appearance of the mucosa at week 6 compared with patients who received placebo. Through week 54, significantly greater proportions of patients in the Simponi 100-mg group maintained clinical response compared with the placebo group. The proportion of patients in clinical response after Simponi induction treatment who went on to demonstrate clinical remission at both weeks 30 and 54, without demonstrating a loss of response at any time point through week 54, were significantly greater in the Simponi 100-mg group compared with the placebo group.

The safety results of Simponi observed in the UC trials were consistent with the known safety profile of Simponi in labeled rheumatologic indications. Adverse events associated with the use of TNF-blockers include an increased risk of infections and some cancers.