Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study
Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study
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DOI：
10.1007/s40744-019-0163-5
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发表时间：
2019-09-01
影响因子：
3.8
通讯作者：
Abrams, Ken
中科院分区：
文献类型：
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作者：
Kivitz, Alan J.;Nash, Peter;Abrams, Ken
在FUTURE 4 （NCT02294227）研究中，通过104周的时间评估活动性银屑病关节炎（PsA）患者皮下（sc） secukinumab 150mg带负荷（150mg）或无负荷（150mg空载）方案的有效性和安全性。方法PsA患者（N = 341）在基线、第1、2、3周和此后每4周随机接受sc . secukinumab 150 mg、150 mg空载或安慰剂治疗。所有安慰剂患者在第16周（无反应）或第24周（有反应）重新分配到secukinumab 150mg空载组。主要终点是第16周时的ACR20。从第36周开始，根据医生的决定，患者的剂量可以从150毫克增加到300毫克。还评估了升级前和升级后的ACR和PASI反应。结果共95.6%（326/341）、84.5%（288/341）和79.8%（272/341）的患者完成了16周、52周和104周的治疗。达到主要终点；150 mg和150 mg空载组在第16周的ACR20反应率分别为41.2%和39.8%，而安慰剂组（18.4%；两个治疗组的调整P值= 0.0003）。两种治疗方案在第16周观察到的疗效反应持续到第52周和第104周，许多患者在第104周继续表现出改善。在剂量增加到300mg后，非/低水平ACR/PASI反应的患者比例随着较高ACR/PASI反应的患者比例的增加而下降。没有新的或意外的安全信号报告。结论：在104周内，secukinumab 150 mg或150 mg空载方案在银屑病关节炎的体征和症状方面表现出显著和持续的改善；在一些高障碍终点，加载方案与数值上更高和更早的反应有关。当剂量从150毫克增加到300毫克时，疗效得到改善。安全概况与以前的报告一致。资助瑞士巴塞尔诺华制药公司。
Introduction To assess the efficacy and safety of the subcutaneous (s.c.) secukinumab 150 mg with loading (150 mg) or without loading (150 mg no-load) regimen through 104 weeks in patients with active psoriatic arthritis (PsA) in the FUTURE 4 (NCT02294227) study. Methods Patients with PsA (N = 341) were randomized to s.c. secukinumab 150 mg, 150 mg no-load or placebo at baseline, weeks 1, 2, 3 and every 4 weeks thereafter. All placebo patients were reassigned to secukinumab 150 mg no-load at either week 16 (non-responders) or week 24 (responders). The primary end point was ACR20 at week 16. Patients could have their dose escalated from 150 to 300 mg based on their physician's decision starting at week 36. Pre- and post-escalation ACR and PASI responses were also assessed. Results A total of 95.6% (326/341), 84.5% (288/341) and 79.8% (272/341) patients completed 16, 52 and 104 weeks of treatment, respectively. The primary end point was met; ACR20 response rate at week 16 was 41.2% and 39.8% with the 150 mg and 150 mg no-load groups, respectively, versus placebo (18.4%; adjusted P value = 0.0003 for both treatment arms). Efficacy responses observed at week 16 in both treatment regimens were sustained up to week 52 and 104, with many patients continuing to show improvements up to week 104. After dose escalation to 300 mg, the proportion of patients with non-/low-level ACR/PASI response decreased with increasing proportions of patients having higher ACR/PASI responses. No new or unexpected safety signals were reported. Conclusion The secukinumab 150 mg or 150 mg no-load regimen demonstrated significant and sustained improvements in the signs and symptoms of psoriatic arthritis through 104 weeks; the loading regimen was associated with numerically higher and earlier responses for some high-hurdle end points. Improved efficacy was observed upon dose escalation from 150 to 300 mg. The safety profile was consistent with previous reports. Funding Novartis Pharma AG, Basel, Switzerland.