Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomized phase III trial (AMAGINE-1).
Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomized phase III trial (AMAGINE-1).
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DOI：
10.1111/bjd.19132
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Jacobson A
中科院分区：
文献类型：
--
作者：
Papp K;Menter A;Leonardi C;Soung J;Weiss S;Pillai R;Jacobson A
Brodalumab可有效治疗中度至重度斑块型银屑病52周。评估brodalumab在120周内的疗效和安全性，包括停药和再治疗。在基线时，患者被随机分配到brodalumab （n = 222）或安慰剂（n = 220）组。在第12周，使用brodalumab获得静态医师总体评估（sPGA）评分为0或1 （sPGA 0/1）的患者被重新随机分配到brodalumab （n = 83）或安慰剂（n = 84；如果sPGA≥3发生，随后再使用brodalumab进行治疗），接受安慰剂的患者切换到brodalumab （n = 208）。安全性通过暴露调整后的治疗不良事件发生率进行评估。在第12周达到sPGA 0/1并被重新随机分配到brodalumab的患者中，分别有96%和80%使用观察数据，74%和61%使用无应答imputation，在第120周银屑病面积和严重程度指数（PASI 75）和PASI 100改善了75%。停用brodalumab后，疾病复发的平均±SD持续时间为74.7±505天。在第12周从brodalumab切换到安慰剂的患者中，使用观察数据和无反应推定的PASI 75率在第20周分别为55%和51%，在第120周分别为94%和75%；第120周PASI 100率分别为75%和60%。在安慰剂之后接受brodalumab治疗的患者，其疗效维持到第120周。没有观察到新的安全信号。这些研究结果表明，brodalumab对于牛皮癣的持续长期治疗是有效和安全的，并且支持停药和再治疗后的反应潜力。关于这个话题我们已经知道了什么？鉴于银屑病患者经常停止和重新开始治疗，生物制剂的持续有效性和安全性是银屑病患者未满足的需求。Brodalumab是一种全人源抗白细胞介素17受体a单克隆抗体，被批准用于治疗对其他全身治疗反应不足的中度至重度牛皮癣患者。这项研究补充了什么？目前的研究在AMAGINE‐1中评估了brodalumab 120周的疗效和安全性，包括停药和再治疗。这些数据表明，brodalumab对于牛皮癣的持续长期治疗是有效和安全的，特别是对于那些经历过治疗失误的患者。链接评论：内贾德和汉普顿。[J]中华皮肤科杂志2020；183:984 - 985。在线提供简单的语言摘要
Brodalumab is efficacious for the treatment of moderate‐to‐severe plaque psoriasis through 52 weeks. To evaluate the efficacy and safety of brodalumab through 120 weeks, including following withdrawal and retreatment. At baseline, patients were randomized to brodalumab (n = 222) or placebo (n = 220). At week 12, patients achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 (sPGA 0/1) with brodalumab were rerandomized to brodalumab (n = 83) or placebo (n = 84; later re‐treated with brodalumab if sPGA ≥ 3 occurred), and patients receiving placebo switched to brodalumab (n = 208). Safety was assessed by exposure‐adjusted rates of treatment‐emergent adverse events. Among those who achieved sPGA 0/1 at week 12 and were rerandomized to brodalumab, 96% and 80% using observed data, respectively, and 74% and 61% using nonresponder imputation, respectively, achieved 75% improvement in Psoriasis Area and Severity Index (PASI 75) and PASI 100 at week 120. Following withdrawal from brodalumab, return of disease occurred after a mean ± SD duration of 74·7 ± 50·5 days. Among those who switched from brodalumab to placebo at week 12, PASI 75 rates using observed data and nonresponder imputation were 55% and 51% at week 20, respectively and 94% and 75% at week 120, respectively; PASI 100 rates at week 120 were 75% and 60%, respectively. Efficacy was maintained through week 120 in those receiving brodalumab after placebo. No new safety signals were observed. These findings indicate that brodalumab is efficacious and safe for continuous long‐term treatment of psoriasis, and support the potential for response after discontinuation and retreatment. What is already known about this topic? Sustained efficacy and safety of biologics is an unmet need in patients with psoriasis, given that patients frequently discontinue and restart psoriasis therapies. Brodalumab is a fully human anti‐interleukin‐17 receptor A monoclonal antibody approved for the treatment of moderate‐to-severe psoriasis in patients who had inadequate responses to other systemic therapies. What does this study add? The current study evaluated the efficacy and safety of brodalumab through 120 weeks in AMAGINE‐1, including following withdrawal and retreatment. These data indicate that brodalumab is efficacious and safe for continuous long‐term treatment of psoriasis, particularly in patients who have experienced a lapse in their treatment. Linked Comment: Babakinejad and Hampton. Br J Dermatol 2020; 183:984–985. Plain language summary available online
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影响因子：
13.8
作者：
Lebwohl, Mark;Leonardi, Craig;Strober, Bruce
通讯作者：
Strober, Bruce
影响因子：
13.8
作者：
Blauvelt, Andrew;Gooderham, Melinda;Reich, Kristian
通讯作者：
Reich, Kristian
DOI：
10.1111/jdv.13611
发表时间：
2016-07-01
影响因子：
9.2
作者：
Menter, A.;Papp, K. A.;Krueger, G. G.
通讯作者：
Krueger, G. G.
影响因子：
10.3
作者：
Bissonnette, R.;Iversen, L.;Wolk, R.
通讯作者：
Wolk, R.
影响因子：
10.3
作者：
Iskandar, I. Y. K.;Ashcroft, D. M.;Griffiths, C. E. M.
通讯作者：
Griffiths, C. E. M.