Long-term efficacy and safety of omalizumab for nasal polyposis in an open-label extension study
Long-term efficacy and safety of omalizumab for nasal polyposis in an open-label extension study
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DOI：
10.1016/j.jaci.2021.07.045
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发表时间：
2022-03-03
影响因子：
14.2
通讯作者：
Bachert, Claus
中科院分区：
文献类型：
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作者：
Gevaert, Philippe;Saenz, Rebecca;Bachert, Claus
背景：慢性鼻-鼻窦炎合并鼻息肉(CRSwNP)尽管进行了最大限度的药物治疗和鼻腔手术，但仍然经常得不到控制，出现了一些未得到满足的需求和挑战。奥马珠单抗先前在重复的3期随机安慰剂对照试验(息肉1，息肉2)中显示了对CRSwNP的有效性。目的：这项开放标签扩展评估了完成息肉1或2的CRSwNP成人患者奥马珠单抗反应的持续有效性、安全性和持久性。方法：在息肉1和2接受奥马利单抗或安慰剂治疗24周后，249名患者接受开放标签奥马利单抗加背景鼻腔莫美松治疗28周，随后在奥马利单抗停用后随访24周。疗效终点评估与基线相比的变化情况，包括鼻腔终点、鼻息肉评分和鼻塞评分，以及鼻-鼻结局测试22的次要终点、总鼻部症状评分及其组成部分和宾夕法尼亚大学气味识别测试评分。安全性目标包括不良事件的发生率和导致停用奥马珠单抗的不良事件的发生率。结果：在52周内，继续使用奥马珠单抗的患者在主要终点和次要终点都有进一步的改善。从安慰剂转向奥马珠单抗的患者在52周的终点都有良好的反应，类似于第24周的息肉1和2。停用奥马珠单抗后，在24周的随访中，评分逐渐恶化，但与治疗前水平相比，两组的评分仍有改善。安全性描述与以前的报道相似。结论：本研究的有效性和安全性描述支持对鼻腔皮质类固醇激素反应不足的CRSwNP患者延长奥马珠单抗治疗长达1年。
Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) frequently remains uncontrolled despite maximal medical therapy and sinonasal surgery, presenting several unmet needs and challenges. Omalizumab previously demonstrated efficacy in CRSwNP in duplicate phase 3, randomized, placebo-controlled trials (POLYP 1, POLYP 2).Objective: This open-label extension evaluated the continued efficacy, safety, and durability of response of omalizumab in adults with CRSwNP who completed POLYP 1 or 2.Methods: After 24 weeks of omalizumab or placebo in POLYP 1 and 2, patients (n = 249) received open-label omalizumab plus background nasal mometasone therapy for 28 weeks and were subsequently followed for 24 weeks after omalizumab discontinuation. Efficacy end points assessed change from baseline for the coprimary end points, Nasal Polyp Score and Nasal Congestion Score, and the secondary end points of Sino-Nasal Outcome Test 22, Total Nasal Symptom Score and its components, and University of Pennsylvania Smell Identification Test scores. Safety objectives included incidence of adverse events and adverse events leading to omalizumab discontinuation.Results: Patients who continued omalizumab experienced further improvements across coprimary end points and secondary end points through 52 weeks. Patients who switched from placebo to omalizumab experienced favorable responses across end points through week 52 that were similar to POLYP 1 and 2 at week 24. After omalizumab discontinuation, scores gradually worsened over the 24-week follow-up, but remained improved from pretreatment levels for both groups. The safety profile was similar to previous reports.Conclusions: The efficacy and safety profile from this study supports extended omalizumab treatment up to 1 year for CRSwNP with inadequate response to nasal corticosteroids.