PDF(Pubmed)
Abstract：
UNASSIGNED: This post hoc analysis assessed disease characteristics and response to dupilumab treatment in male and female patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) (SINUS-52 study; NCT02898454).
UNASSIGNED: Patients received dupilumab 300 mg or placebo every 2 weeks for 52 weeks on background intranasal corticosteroids. Efficacy was assessed through Week 52 using nasal polyp score (NPS), nasal congestion/obstruction score, loss of smell score and University of Pennsylvania Smell Identification Test score. Disease-specific health-related quality of life (HRQoL) was assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22).
UNASSIGNED: The analysis included 192 male and 111 female patients. Female patients had higher mean SNOT-22 total score (56.6 vs. 49.1, P < 0.01) and more coexisting asthma (78.4% vs. 46.4%, P < 0.0001) and non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD) (38.7% vs. 18.8%, P = 0.0001) than male patients, but other baseline characteristics were similar. Dupilumab significantly improved CRSwNP outcomes vs. placebo at Week 52, regardless of gender: least squares mean differences (95% confidence interval) for NPS were -2.33 (-2.80, -1.86) in male and -2.54 (-3.18, -1.90) in female patients (both P < 0.0001 vs. placebo), and for SNOT-22 were -19.2 (-24.1, -14.2) in male and -24.4 (-31.5, -17.3) in female patients (both P < 0.0001 vs. placebo). There were no significant efficacy-by-gender interactions.
UNASSIGNED: Female patients had greater asthma, NSAID-ERD and HRQoL burden at baseline than male patients. Dupilumab treatment significantly improved objective and subjective outcomes compared with placebo, irrespective of gender.
UNASSIGNED: Patients received dupilumab 300 mg or placebo every 2 weeks for 52 weeks on background intranasal corticosteroids. Efficacy was assessed through Week 52 using nasal polyp score (NPS), nasal congestion/obstruction score, loss of smell score and University of Pennsylvania Smell Identification Test score. Disease-specific health-related quality of life (HRQoL) was assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22).
UNASSIGNED: The analysis included 192 male and 111 female patients. Female patients had higher mean SNOT-22 total score (56.6 vs. 49.1, P < 0.01) and more coexisting asthma (78.4% vs. 46.4%, P < 0.0001) and non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD) (38.7% vs. 18.8%, P = 0.0001) than male patients, but other baseline characteristics were similar. Dupilumab significantly improved CRSwNP outcomes vs. placebo at Week 52, regardless of gender: least squares mean differences (95% confidence interval) for NPS were -2.33 (-2.80, -1.86) in male and -2.54 (-3.18, -1.90) in female patients (both P < 0.0001 vs. placebo), and for SNOT-22 were -19.2 (-24.1, -14.2) in male and -24.4 (-31.5, -17.3) in female patients (both P < 0.0001 vs. placebo). There were no significant efficacy-by-gender interactions.
UNASSIGNED: Female patients had greater asthma, NSAID-ERD and HRQoL burden at baseline than male patients. Dupilumab treatment significantly improved objective and subjective outcomes compared with placebo, irrespective of gender.
摘要：
■该事后分析评估了患有严重慢性鼻窦炎伴鼻息肉（CRSwNP）的男性和女性患者的疾病特征和对dupilumab治疗的反应（SINUS-52研究；NCT02898454）。
■患者每2周接受dupilumab300mg或安慰剂，持续52周，背景鼻内皮质类固醇。通过第52周使用鼻息肉评分（NPS）评估疗效，鼻塞/阻塞评分,嗅觉丧失评分和宾夕法尼亚大学嗅觉识别测试评分。使用22项鼻鼻部结果测试（SNOT-22）评估特定疾病的健康相关生活质量（HRQoL）。
■分析包括192名男性和111名女性患者。女性患者的平均SNOT-22总分较高（56.6vs.49.1，P<0.01）和更并存的哮喘（78.4％vs.46.4%,P<0.0001）和非甾体抗炎药物加重呼吸道疾病（NSAID-ERD）（38.7％vs.18.8%,P=0.0001）比男性患者，但其他基线特征相似.Dupilumab显着改善CRSwNP结果与第52周安慰剂，不分性别：男性患者NPS的最小二乘平均差（95％置信区间）为-2.33（-2.80，-1.86），女性患者为-2.54（-3.18，-1.90）（均P<0.0001vs.安慰剂)，男性患者的SNOT-22为-19.2（-24.1，-14.2），女性患者为-24.4（-31.5，-17.3）（P<0.0001vs.安慰剂)。没有明显的功效性别互动。
■女性患者有更大的哮喘，基线时NSAID-ERD和HRQoL负荷高于男性患者。与安慰剂相比，Dupilumab治疗显着改善客观和主观结果，不分性别。
■患者每2周接受dupilumab300mg或安慰剂，持续52周，背景鼻内皮质类固醇。通过第52周使用鼻息肉评分（NPS）评估疗效，鼻塞/阻塞评分,嗅觉丧失评分和宾夕法尼亚大学嗅觉识别测试评分。使用22项鼻鼻部结果测试（SNOT-22）评估特定疾病的健康相关生活质量（HRQoL）。
■分析包括192名男性和111名女性患者。女性患者的平均SNOT-22总分较高（56.6vs.49.1，P<0.01）和更并存的哮喘（78.4％vs.46.4%,P<0.0001）和非甾体抗炎药物加重呼吸道疾病（NSAID-ERD）（38.7％vs.18.8%,P=0.0001）比男性患者，但其他基线特征相似.Dupilumab显着改善CRSwNP结果与第52周安慰剂，不分性别：男性患者NPS的最小二乘平均差（95％置信区间）为-2.33（-2.80，-1.86），女性患者为-2.54（-3.18，-1.90）（均P<0.0001vs.安慰剂)，男性患者的SNOT-22为-19.2（-24.1，-14.2），女性患者为-24.4（-31.5，-17.3）（P<0.0001vs.安慰剂)。没有明显的功效性别互动。
■女性患者有更大的哮喘，基线时NSAID-ERD和HRQoL负荷高于男性患者。与安慰剂相比，Dupilumab治疗显着改善客观和主观结果，不分性别。
