Real-world Outcomes Following Biologic Initiation in US Patients with Chronic Rhinosinusitis with Nasal Polyps

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-02-19 DOI:10.1007/s12325-025-03120-y

Anju Peters, Xiaohui Zhao, Aimee M. Near, Joseph Han, Joseph D. Spahn, Sze-jung S. Wu, Andrew W. Lindsley, Tham T. Le, Elizabeth J. Wang, Rifat Tuly, Inyoung Lee, Christopher S. Ambrose

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引用次数: 0

Abstract

Introduction

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is often associated with persistent symptoms and impaired quality of life despite treatment with intranasal corticosteroids. Biologics (dupilumab, mepolizumab, omalizumab) have been recently approved for CRSwNP. This study aims to characterize biologic use and real-world outcomes, including medication use and nasal polyps (NP) surgeries, following biologic treatment in US patients with CRSwNP.

Methods

This retrospective cohort study analyzed linked data from IQVIA longitudinal prescription and medical claims databases (July 2018–June 2023). Patients evaluated included those with ≥ 2 diagnoses of CRSwNP and ≥ 12 months of baseline data (overall cohort, index = first observed CRSwNP diagnosis) as well as patients with CRSwNP who received ≥ 2 consecutive biologic doses and had ≥ 24 months of follow-up data (biologic cohort, index = first biologic).

Results

Of 74,480 patients with CRSwNP, 8716 (12.0%) received a biologic and 2208 met all inclusion criteria. Dupilumab was the most frequently received biologic (89.8%; mepolizumab, 5.3%; omalizumab, 4.8%). Relative to the overall cohort, the biologic cohort was younger (mean age: 52.6 vs. 57.6 years), had more women (54.0% vs. 46.1%) and had a higher baseline prevalence of asthma (72.4% vs. 30.9%), allergic rhinitis (70.6% vs. 37.4%), NP surgery (15.8% vs. 5.8%), oral corticosteroid (OCS) use (84.0% vs. 51.8%), and antibiotic use (84.2% vs. 68.7%). During the 24 months after biologic initiation, 65.6% of patients had ≥ 1 OCS use (≥ 2 OCS uses during months 1–12, 27.0%; during months 13–24, 27.0%) and 77.9% had ≥ 1 antibiotic use; and 7.1% of patients without NP surgery before biologic initiation had ≥ 1 NP surgery during follow-up. Almost half of patients (49.3%) discontinued (≥ 90 days without receipt) their initial biologic during follow-up.

Conclusion

Biologic use was relatively low among US patients with CRSwNP. OCS and antibiotic usage among patients with CRSwNP remained substantial despite use of currently approved biologics, indicating an unmet need for improved treatment options.

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美国慢性鼻窦炎合并鼻息肉患者生物起始治疗后的实际结果。

慢性鼻窦炎伴鼻息肉病（CRSwNP）常伴有持续症状和生活质量下降，尽管使用鼻内皮质类固醇治疗。生物制剂（dupilumab, mepolizumab, omalizumab）最近已被批准用于CRSwNP。本研究旨在描述美国CRSwNP患者生物治疗后的生物使用和现实结果，包括药物使用和鼻息肉（NP）手术。方法：本回顾性队列研究分析了IQVIA纵向处方和医疗索赔数据库（2018年7月至2023年6月）的相关数据。评估的患者包括诊断≥2次CRSwNP且基线数据≥12个月的患者（总体队列，指标=首次观察到的CRSwNP诊断），以及连续接受≥2次生物制剂剂量且随访数据≥24个月的CRSwNP患者（生物队列，指标=首次生物制剂）。结果：在74,480例CRSwNP患者中，8716例（12.0%）接受了生物制剂治疗，2208例符合所有纳入标准。Dupilumab是最常见的生物制剂(89.8%；mepolizumab, 5.3%;omalizumab, 4.8%)。相对于整个队列，生物学队列更年轻（平均年龄：52.6岁对57.6岁），女性更多（54.0%对46.1%），哮喘（72.4%对30.9%）、过敏性鼻炎（70.6%对37.4%）、NP手术（15.8%对5.8%）、口服皮质类固醇（OCS）使用（84.0%对51.8%）和抗生素使用（84.2%对68.7%）的基线患病率更高。在生物启动后的24个月内，65.6%的患者使用≥1次OCS(1-12个月使用≥2次OCS， 27.0%；13 ~ 24个月，27.0%和77.9%的患者使用过≥1种抗生素；7.1%的患者在生物启动前未做过NP手术，随访期间进行了≥1次NP手术。几乎一半的患者（49.3%）在随访期间停止了最初的生物制剂（≥90天未收到）。结论：美国CRSwNP患者的生物制剂使用率相对较低。尽管使用了目前批准的生物制剂，但CRSwNP患者的OCS和抗生素使用量仍然很大，这表明对改进治疗方案的需求尚未得到满足。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.