BACKGROUND Randomized controlled trials have shown the efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis. OBJECTIVE To evaluate the efficacy and safety of brodalumab through 120 weeks of treatment in the AMAGINE-2 trial. METHODS Patients received ustekinumab through week 52 followed by brodalumab 210 mg every 2 weeks, continuous brodalumab 210 mg every 2 weeks, or any dose of brodalumab. Efficacy data were reported through 120 weeks by using observed data, last observation carried forward, and nonresponder imputation analyses. RESULTS Of patients who received brodalumab 210 mg every 2 weeks, 84.4%, 75.6%, and 61.1% achieved 75%, 90%, and 100% improvement from baseline in Psoriasis Area and Severity Index at 120 weeks (observed data analysis), respectively. Patients who received brodalumab 210 mg every 2 weeks after receiving ustekinumab through 52 weeks achieved a similar skin clearance response as patients who received continuous brodalumab 210 mg every 2 weeks. Safety through 120 weeks was comparable to that of the blinded study periods. LIMITATIONS A large number of discontinuations toward the end of the study (31% in the final 6 months) were due to early termination and led to differences between observed data and nonresponder imputation results. CONCLUSIONS Brodalumab is well tolerated and showed robust efficacy for more than 2 years.

中文翻译：

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Brodalumab在治疗牛皮癣中的长期疗效和安全性：来自随机，双盲，安慰剂和活性比较物对照的3期AMAGINE-2试验的120周结果。

背景技术随机对照试验显示，溴达单抗在中度至重度斑块状牛皮癣患者中的疗效和安全性。目的在AMAGINE-2试验中评估通过120周治疗的Brodalumab的疗效和安全性。方法患者在第52周之前接受ustekinumab，然后每2周接受180 mg brodalumab，每2周持续接受brodalumab 210 mg或任何剂量的brodalumab。使用观察到的数据报告功效数据，持续120周，最后一次观察到结转，并进行无反应者归因分析。结果每两周接受布罗达单抗210 mg的患者，在120周时银屑病面积和严重性指数分别较基线分别提高84.4％，75.6％和61.1％（观察数据分析）。 。在接受ustekinumab治疗至52周后，每2周接受了brodalumab 210 mg的患者，其皮肤清除反应与每2周接受持续brodalumab 210 mg的患者相似。120周的安全性与盲法研究期间的安全性相当。局限性到研究结束时大量停药（在最后6个月中占31％）是由于提早终止而导致观察到的数据与无反应者估算结果之间的差异。结论Brodalumab具有良好的耐受性，并且在2年以上的时间里显示出强大的疗效。局限性到研究结束时大量停药（在最后6个月中占31％）是由于提早终止而导致观察到的数据与无反应者估算结果之间的差异。结论Brodalumab具有良好的耐受性，并且在2年以上的时间里显示出强大的疗效。局限性到研究结束时大量停药（在最后6个月中占31％）是由于提早终止而导致观察到的数据与无反应者估算结果之间的差异。结论Brodalumab具有良好的耐受性，并且在2年以上的时间里显示出强大的疗效。