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Assessment of rebound and relapse following ecallantide treatment for acute attacks of hereditary angioedema

机译：callantide治疗遗传性血管性水肿急性发作后反弹和复发的评估

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Background Hereditary angioedema (HAE) is a rare genetic disease characterized by unpredictable and recurring attacks of angioedema. This study assessed potential attack rebound and relapse following treatment with ecallantide, a plasma kallikrein inhibitor approved for HAE attack treatment. Methods Results were integrated from 2 double-blind, placebo-controlled studies of ecallantide treatment for HAE: EDEMA3-DB and EDEMA4. Symptoms were assessed by treatment outcome score (TOS), mean symptom complex severity (MSCS) score, and global response. Patients with improvement at 4 h post-dosing in all three measures followed by any sign of worsening at 24 h were considered to show potential rebound if worsening was beyond baseline or potential relapse if not beyond baseline. Likeliness of rebound or relapse was determined by the number of measures showing worsening and the magnitude of worsening. Patients receiving placebo who met the criteria for rebound/relapse were evaluated for descriptive comparison only. Results Significantly more ecallantide-treated patients (42 of 70) compared to placebo (26 of 71) showed improvement in three measures at 4 h and were thus eligible for rebound/relapse (P = 0.006). Of the nine ecallantide-treated patients with signs of worsening at 24 h, none were likely rebound, one was assessed as possible rebound, one as likely relapse, and two as possible relapse. No patient with potential rebound/relapse experienced new symptoms after dosing. Medical intervention was required in one ecallantide-treated patient. Conclusion Ecallantide was efficacious for treating acute HAE attacks. Relapse was observed in a small proportion of patients, and there was little evidence of rebound.
机译：背景遗传性血管性水肿（HAE）是一种罕见的遗传性疾病，其特征是血管性水肿的发作无法预测且反复发作。这项研究评估了用ecallantide（一种被批准用于HAE发作治疗的血浆激肽释放酶抑制剂）治疗后潜在的发作反弹和复发。方法EDEMA3-DB和EDEMA4是两项针对EHA的药物的双盲，安慰剂对照研究的结果。通过治疗结局评分（TOS），平均症状复杂程度（MSCS）评分和总体反应评估症状。在所有三种措施中，服药后4小时都有改善并在24小时出现任何恶化迹象的患者，如果恶化超出基线，则被视为显示潜在的反弹，如果未超出基线，则被视为具有潜在的复发。反弹或复发的可能性取决于显示恶化的措施数量和恶化的程度。接受安慰剂且符合反弹/复发标准的患者仅作描述性比较评估。结果与安慰剂相比，接受安慰剂治疗的患者（70名中的42名）与安慰剂组（71名中的26名）相比，在4 h时有3项措施明显改善，因此有资格反弹/复发（P = 0.006）。在24小时内出现恶化迹象的9例接受呼方肽治疗的患者中，没有一个可能反弹，其中1个被评估为可能的反弹，1个可能的复发和2个可能的复发。给药后没有潜在反弹/复发的患者出现新症状。一名接受callantantide治疗的患者需要医疗干预。结论Ecallantide对治疗急性HAE发作有效。一小部分患者观察到复发，并且几乎没有反弹的迹象。

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