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Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial
Journal of Allergy and Clinical Immunology ( IF 14.2 ) Pub Date : 2017-07-04 , DOI: 10.1016/j.jaci.2017.05.044
Claus Bachert 1 , Ana R Sousa 2 , Valerie J Lund 3 , Glenis K Scadding 3 , Philippe Gevaert 4 , Shuaib Nasser 5 , Stephen R Durham 6 , Marjolein E Cornet 7 , Harsha H Kariyawasam 3 , Jane Gilbert 8 , Daren Austin 2 , Aoife C Maxwell 9 , Richard P Marshall 2 , Wytske J Fokkens 7
Affiliation  

Background

Patients with eosinophilic nasal polyposis frequently require surgery, and recurrence rates are high.

Objective

We sought to assess the efficacy and safety of mepolizumab versus placebo for severe bilateral nasal polyposis.

Methods

This randomized, double-blind, placebo-controlled trial recruited patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery. Patients received 750 mg of intravenous mepolizumab or placebo every 4 weeks for a total of 6 doses in addition to daily topical corticosteroid treatment. The primary end point was the number of patients no longer requiring surgery at Week 25 based on a composite end point of endoscopic nasal polyp score and nasal polyposis severity visual analog scale (VAS) score. Secondary end points included change in nasal polyposis severity VAS score, endoscopic nasal polyp score, improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes, and safety.

Results

One hundred five patients received mepolizumab (n = 54) or placebo (n = 51). A significantly greater proportion of patients in the mepolizumab group compared with the placebo group no longer required surgery at Week 25 (16 [30%] vs 5 [10%], respectively; P = .006). There was a significant improvement in nasal polyposis severity VAS score, endoscopic nasal polyp score, all individual VAS symptom scores, and Sino-Nasal Outcome Test patient-reported outcome score in the mepolizumab compared with placebo groups. Mepolizumab's safety profile was comparable with that of placebo.

Conclusion

In patients with recurrent nasal polyposis receiving topical corticosteroids who required surgery, mepolizumab treatment led to a greater reduction in the need for surgery and a greater improvement in symptoms than placebo.



中文翻译:

使用美泊利单抗减少严重鼻息肉病的手术需求:随机试验

背景

嗜酸性鼻息肉患者经常需要手术治疗,复发率很高。

客观的

我们试图评估美泊利单抗与安慰剂治疗严重双侧鼻息肉病的疗效和安全性。

方法

这项随机、双盲、安慰剂对照试验招募了年龄在 18 至 70 岁的复发性鼻息肉病需要手术的患者。除了每日局部皮质类固醇治疗外,患者每 4 周接受 750 mg 静脉注射美泊利单抗或安慰剂,共 6 剂。主要终点是根据内窥镜鼻息肉评分和鼻息肉严重程度视觉模拟评分 (VAS) 评分的复合终点,在第 25 周不再需要手术的患者数量。次要终点包括鼻息肉病严重程度 VAS 评分的变化、内窥镜鼻息肉评分、个体 VAS 症状(鼻漏、喉咙粘液、鼻塞和嗅觉)的改善、患者报告的结果和安全性。

结果

105 名患者接受了美泊利单抗(n = 54)或安慰剂(n = 51)。与安慰剂组相比,美泊利单抗组患者在第 25 周不再需要手术的比例显着增加(分别为 16 [30%] vs 5 [10%];P  = .006)。与安慰剂组相比,美泊利单抗组的鼻息肉病严重程度 VAS 评分、内窥镜鼻息肉评分、所有个体 VAS 症状评分和鼻腔结果测试患者报告的结果评分有显着改善。Mepolizumab 的安全性与安慰剂相当。

结论

在需要手术的复发性鼻息肉病患者中,接受局部皮质类固醇治疗,与安慰剂相比,美泊利单抗治疗导致手术需求的更大减少和症状的更大改善。

更新日期:2017-07-04
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