Sanofi and Regeneron Pharmaceuticals, Inc. today presented positive results from the EVEREST phase 4 study of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In the study, Dupixent (dupilumab) outperformed Xolair (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. The data are from the first-ever presented head-to-head respiratory study with biologic medicines and were shared today in a late-breaking oral presentation at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress, Glasgow, UK.

赛诺菲和再生元制药公司今日公布了EVEREST 4期临床试验的积极结果，该试验针对伴有鼻息肉（CRSwNP）并合并哮喘的成人患者。研究中，Dupixent（dupilumab）在CRSwNP的所有主要和次要疗效终点以及所有哮喘相关终点上均优于Xolair（omalizumab）。该数据来自一项首例生物制剂头对头呼吸系统研究，并于今日在英国格拉斯哥举行的2025年欧洲过敏和临床免疫学会（EAACI）年会上以口头报告的形式进行了分享。

Eugenio De Corso, MD, PhD ENT Specialist, Otolaryngology, Head and Neck Surgery, Rhinology, A. Gemelli University Hospital Foundation, IRCSS, Rome, Italy, and lead investigator of the study

Eugenio De Corso 医学博士、哲学博士，意大利罗马 A. Gemelli 大学医院基金会、IRCSS 耳鼻喉科、头颈外科、鼻科耳鼻喉科专家，也是该研究的首席研究员。

“Patients suffering from chronic rhinosinusitis with nasal polyps often live with the constant obstruction of their nasal passages that can lead to burdensome nasal congestion and loss of smell. What’s more, a majority of these individuals also have asthma that can substantially impact their quality of life. EVEREST is the first-ever trial to demonstrate the superiority of Dupixent over Xolair on CRSwNP endpoints in patients with coexisting asthma, along with generally similar safety profiles. Together, these Dupixent outcomes provide important insights that will help guide patients and physicians through the treatment decision-making process.”

“患有鼻息肉的慢性鼻窦炎患者经常会忍受鼻腔持续阻塞的痛苦，这会导致严重的鼻塞和嗅觉丧失。此外，这些患者中的大多数还患有哮喘，这会严重影响他们的生活质量。EVEREST 是有史以来第一个证明 Dupixent 在合并哮喘的患者中在慢性鼻窦炎 (CRSwNP) 终点方面优于 Xolair 的试验，并且安全性大致相似。总之，这些 Dupixent 结果提供了重要的见解，将有助于指导患者和医生完成治疗决策过程。”

In the EVEREST study, 360 adults with severe, uncontrolled CRSwNP and coexisting asthma were randomized to receive Dupixent 300 mg (n=181) every two weeks or a weight- and immunoglobulin E (IgE) level-based dosing regimen of omalizumab (n=179) every two or four weeks. Both Dupixent and omalizumab were added to background mometasone furoate nasal spray (MFNS).

在EVEREST研究中，360名患有严重、未控制的慢性鼻窦炎（CRSwNP）并伴有哮喘的成人患者被随机分配接受每两周一次的Dupixent 300毫克治疗（n=181），或每两周或四周一次基于体重和免疫球蛋白E (IgE)水平的奥马珠单抗给药方案（n=179）。Dupixent和奥马珠单抗均在基础治疗糠酸莫米松鼻喷雾剂(MFNS)的基础上进行添加。

Primary and secondary endpoint results in CRSwNP for patients treated with Dupixent compared to omalizumab at 24 weeks were as follows with differences were seen as early as four weeks:

与奥马珠单抗相比，Dupixent 治疗 24 周后 CRSwNP 患者的主要和次要终点结果如下，差异最早在四周就已显现：

1.60-point superior reduction in nasal polyp size, a primary endpoint (p<0.00011) 8.0-point superior improvement in ability to identify different smells, a primary endpoint (p<0.00011). More patients on Dupixent improved above the anosmia threshold compared to omalizumab 0.58-point superior reduction in nasal congestion/obstruction, a key secondary endpoint (p<0.00011) 0.81-point superior improvement in loss of smell, a key secondary endpoint (p<0.00011) 1.74-point superior reduction in symptom severity (p<0.00011) 12.7-point difference in health-related quality of life (p<0.00012) 31.27-point difference in peak nasal inspiratory flow (p<0.00012) 1.87 difference in overall severity of rhinosinusitis (p<0.00012) Asthma endpoint results for patients treated with Dupixent compared to omalizumab at 24 weeks were as follows, with differences seen as early as four weeks:

鼻息肉大小减少1.60 分，这是主要终点（p<0.0001 1） 辨别不同气味的能力提高了8.0分，这是主要终点（p<0.0001 1）。与奥马珠单抗相比，Dupixent组更多患者嗅觉丧失阈值以上。 鼻塞/鼻塞减少 0.58 分，这是关键的次要终点 (p<0.0001 1 ) 嗅觉丧失改善了 0.81 分，这是关键的次要终点 (p<0.0001 1 ) 症状严重程度降低1.74 个百分点(p<0.0001 1 ) 健康相关生活质量差异12.7分（p< 0.00012） 鼻吸气峰值流量差异为 31.27 分（p<0.0001 2） 鼻窦炎总体严重程度差异为 1.87 （p<0.0001 2） 与奥马珠单抗治疗相比，Dupixent 治疗患者在 24 周时的哮喘终点结果如下，差异最早在四周就已显现： 肺功能差异 150 mL （使用支气管扩张剂前 FEV 1 ； p=0.003 2） 哮喘控制差异为 0.48 分（p<0.0001 2）

The safety results in the EVEREST study were generally consistent with the known safety profile of Dupixent in its approved respiratory indications, with similar overall rates of adverse events (AEs) observed between Dupixent (64%) and omalizumab (67%). Serious AEs were reported in 2% and 4% of patients treated with Dupixent and omalizumab, respectively. Additionally, AEs leading to study discontinuation were reported in 3% of Dupixent patients and 1% of omalizumab patients.

EVEREST 研究中，安全性结果与 Dupixent 在其已获批准的呼吸系统疾病适应症中的已知安全性基本一致，Dupixent (64%) 和奥马珠单抗 (67%) 的总体不良事件 (AE) 发生率相似。Dupixent 和奥马珠单抗治疗患者中，严重不良事件 (AE) 报告率分别为 2% 和 4%。此外，Dupixent 患者和奥马珠单抗患者中，报告导致研究终止的不良事件发生率分别为 3% 和 1%。

About the Dupixent phase 4 study

关于 Dupixent 4 期临床试验

EVEREST is a randomized, double-blind phase 4 study comparing the efficacy and safety of Dupixent to omalizumab in adults with severe, uncontrolled CRSwNP and coexisting mild, moderate, or severe asthma. During the 24-week study, patients received Dupixent 300 mg every two weeks or omalizumab 75 to 600 mg every two or four weeks, which was added to background MFNS. Omalizumab dosing was determined based on body weight and serum total IgE levels as per the approved label. All endpoints were assessed at 24 weeks.

EVEREST 是一项随机、双盲 4 期临床试验，旨在比较 Dupixent 与奥马珠单抗在重度、未控制的慢性鼻窦炎 (CRSwNP) 伴有轻度、中度或重度哮喘的成人患者中的疗效和安全性。在这项为期 24 周的研究中，患者每两周接受 300 毫克 Dupixent 治疗，或每两周或四周接受 75 至 600 毫克奥马珠单抗治疗，后者被添加到基础 MFNS 治疗中。奥马珠单抗的剂量根据体重和血清总 IgE 水平确定，并符合获批的说明书。所有终点均在 24 周时进行评估。

The primary endpoints assessed change from baseline in nasal polyp score (scale: 0-8) and the University of Pennsylvania Smell Identification Test (scale: 0-40). Secondary endpoints included change from baseline in nasal congestion (scale: 0-3), loss of smell (scale: 0-3), total symptom score (scale: 0-9), SNOT-22 (scale: 0-110), peak nasal inspiratory flow, and rhinosinusitis disease severity (visual analogue scale: 0-10 cm). Other endpoints assessed pre-bronchodilator forced expiratory volume over one second and the 7-item Asthma Control Questionnaire (scale: 0-6).

主要终点评估鼻息肉评分（量表：0-8 分）和宾夕法尼亚大学嗅觉识别测试（量表：0-40 分）相对于基线的变化。次要终点包括鼻塞（量表：0-3 分）、嗅觉丧失（量表：0-3 分）、症状总评分（量表：0-9 分）、SNOT-22（量表：0-110 分）、鼻吸气峰流量和鼻窦炎病情严重程度（视觉模拟量表：0-10 厘米）相对于基线的变化。其他终点评估支气管扩张剂治疗前一秒用力呼气量和 7 项哮喘控制问卷（量表：0-6 分）。

About Dupixent

关于 Dupixent

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent (dupilumab) 是一种全人源单克隆抗体，可抑制白细胞介素 4 (IL4) 和白细胞介素 13 (IL13) 信号通路，而非免疫抑制剂。Dupixent 的开发项目已在 3 期临床试验中显示出显著的临床获益，并可减少 2 型炎症，从而证实 IL4 和 IL13 是 2 型炎症的两个关键核心驱动因素，而 2 型炎症在多种相关且常伴有并发症的疾病中发挥着重要作用。

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations. More than one million patients are being treated with Dupixent globally.

Dupixent 已在 60 多个国家获得监管部门批准，用于治疗一种或多种适应症，包括不同年龄段的特应性皮炎、哮喘、慢性鼻窦炎（CRSwNP）、嗜酸细胞性食管炎、结节性痒疹、慢性自发性荨麻疹和慢性阻塞性肺病患者。全球有超过一百万患者正在接受 Dupixent 治疗。