Lake Mary ENT and Allergy, Lake Mary, Florida.
7412Genentech, Inc., South San Francisco, California.
Am J Rhinol Allergy. 2022 Jan;36(1):135-141. doi: 10.1177/19458924211030486. Epub 2021 Aug 12.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease with variable underlying pathophysiologies. Numerous patient factors have been linked to differences in disease severity, control, and response to treatment, including asthma status, aspirin sensitivity, previous sinonasal surgery, and blood eosinophil levels.
The present study examines the efficacy of the anti-immunoglobulin E therapy, omalizumab, versus placebo in patients with CRSwNP from the replicate POLYP 1 (NCT03280550) and POLYP 2 (NCT03280537) trials, grouped by inherent patient characteristics to determine the response to therapy.
Patients in prespecified subgroups from POLYP 1 and POLYP 2 (studies pooled for analysis) were examined. Subgroups included blood eosinophil count at baseline (>300 or ≤300 cells/μL), previous sinonasal surgery (yes or no), asthma status (yes or no), and aspirin sensitivity status (yes or no). Subgroups were examined for subgroup-specific adjusted mean difference (95% confidence interval [CI]) (omalizumab-placebo) in change from baseline at week 24 in Nasal Congestion Score (NCS), Nasal Polyp Score (NPS), Sino-Nasal Outcome Test-22 (SNOT-22), Total Nasal Symptom Score (TNSS), and University of Pennsylvania Smell Identification Test (UPSIT).
Adjusted mean difference (95% CI) (omalizumab-placebo) in NCS, NPS, SNOT-22, TNSS, and UPSIT change from baseline at week 24 consistently favored omalizumab treatment over placebo in patients with blood eosinophil count >300 and ≤300 cells/μL, with or without previous sinonasal surgery, asthma, and aspirin sensitivity.
Together, these data suggest broad efficacy of omalizumab across clinical and patient-reported outcomes in patients with CRSwNP, independent of the underlying patient factors examined, including those with high eosinophil levels and those who have undergone previous surgery, which are associated with high recurrence.
ClinicalTrials.gov identifiers: POLYP 1: ClinicalTrials.gov identifier NCT03280550 (https://clinicaltrials.gov/ct2/show/NCT03280550); POLYP 2: ClinicalTrials.gov identifier NCT03280537 (https://clinicaltrials.gov/ct2/show/NCT03280537).
伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）是一种具有不同潜在病理生理学的异质性疾病。许多患者因素与疾病严重程度、控制程度和治疗反应的差异有关，包括哮喘状态、阿司匹林敏感性、既往鼻窦手术和血嗜酸性粒细胞水平。
本研究通过检查抗免疫球蛋白 E 治疗药物奥马珠单抗相对于安慰剂在来自重复 POLYP 1（NCT03280550）和 POLYP 2（NCT03280537）试验的伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）患者中的疗效，根据固有患者特征将患者分组，以确定对治疗的反应。
对 POLYP 1 和 POLYP 2 中预先指定的亚组（合并分析）的患者进行了检查。亚组包括基线时血嗜酸性粒细胞计数（＞300 或≤300 细胞/μL）、既往鼻窦手术（是或否）、哮喘状态（是或否）和阿司匹林敏感性状态（是或否）。对亚组进行了亚组特异性调整后的平均差值（95%置信区间[CI]）（奥马珠单抗-安慰剂）的分析，以评估基线时 24 周时在鼻腔充血评分（NCS）、鼻腔息肉评分（NPS）、鼻-鼻窦炎结局测试-22 （SNOT-22）、总鼻部症状评分（TNSS）和宾夕法尼亚大学嗅觉识别测试（UPSIT）中的变化。
在基线时血嗜酸性粒细胞计数＞300 和≤300 细胞/μL、有或无既往鼻窦手术、哮喘和阿司匹林敏感性的患者中，奥马珠单抗治疗在 24 周时 NCS、NPS、SNOT-22、TNSS 和 UPSIT 变化的调整平均差值（95%CI）（奥马珠单抗-安慰剂）均有利于奥马珠单抗治疗，优于安慰剂。
总的来说，这些数据表明奥马珠单抗在伴有鼻息肉的慢性鼻-鼻窦炎患者的临床和患者报告结局方面具有广泛的疗效，独立于检查的潜在患者因素，包括那些嗜酸性粒细胞水平较高的患者和那些已经接受过手术的患者，这些患者与高复发率相关。
ClinicalTrials.gov 标识符：POLYP 1：ClinicalTrials.gov 标识符 NCT03280550（https://clinicaltrials.gov/ct2/show/NCT03280550）；POLYP 2：ClinicalTrials.gov 标识符 NCT03280537（https://clinicaltrials.gov/ct2/show/NCT03280537）。
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