关键词: Asthma Biologics CRSwNP Dupilumab Eosinophils Monoclonal antibody Nasal polyposis Real life Type 2 inflammation

来  源:   DOI:10.1007/s00405-024-08553-9

Abstract:
BACKGROUND: Dupilumab, a monoclonal antibody targeting IL-4 and IL-13, has demonstrated its efficacy in several clinical trials. However, to date, real-life data remains limited.
OBJECTIVE: The aim of our study was to assess the real-life impact of dupilumab on patients with severe and uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) quality of life.
METHODS: This was a retrospective, monocentric, observational, real-life study, conducted in accordance with the STROBE guidelines. The following parameters were collected before treatment and at 1, 4, and 12 months: Sino-Nasal Outcome Test-22 (SNOT-22), nasal polyp score (NPS), Sniffin\' Sticks-16 (SST-16), visual analog scale (VAS) for loss of smell, nasal congestion score (NCS), gustatory VAS, asthma control, oral corticosteroid usage, surgery rates, and occurrence of side effects.
RESULTS: The study included 47 patients. SNOT-22 scores decreased from 52.4 ± 24.3 to 12.7 ± 10.5 at 12 months (p < 0.001). NPS decreased from 6.15 ± 1.71 to 1.57 ± 1.40 at 12 months (p < 0.001). SST-16 scores increased from 1.6 ± 2.83 to 9.1 ± 5.4 at 12 months (p < 0.001). NCS decreased from 2.45 ± 0.72 to 0.38 ± 0.63 at 12 months (p < 0.001). Prior to treatment, 72.3% were using oral corticosteroids, compared to 17.0% at 12 months (p < 0.01). Two patients required additional surgery, and 17% reported completely uncontrolled asthma, compared to 0% at 12 months (p < 0.01).
CONCLUSIONS: Our real-life results confirm the efficacy of Dupilumab in the treatment of severe and uncontrolled CRSwNP.
摘要:
背景:Dupilumab,针对IL-4和IL-13的单克隆抗体已在多项临床试验中证明了其有效性。然而,到目前为止,真实数据仍然有限。
目的:本研究的目的是评估dupilumab对重度和未控制的慢性鼻窦炎伴鼻息肉(CRSwNP)患者生活质量的影响。
方法:这是一个回顾性研究,单心,观察,现实生活中的研究,按照STROBE指南进行。在治疗前和1、4和12个月时收集以下参数:鼻鼻塞结果测试-22(SNOT-22),鼻息肉评分(NPS),Sniffin\'棒-16(SST-16),嗅觉丧失的视觉模拟量表(VAS),鼻塞评分(NCS),味觉VAS,哮喘控制,口服皮质类固醇的使用,手术率,以及副作用的发生。
结果:该研究包括47名患者。SNOT-22评分在12个月时从52.4±24.3降至12.7±10.5(p<0.001)。NPS在12个月时从6.15±1.71降至1.57±1.40(p<0.001)。SST-16评分在12个月时从1.6±2.83增加到9.1±5.4(p<0.001)。在12个月时,NCS从2.45±0.72下降到0.38±0.63(p<0.001)。治疗前,72.3%使用口服糖皮质激素,与12个月时的17.0%相比(p<0.01)。两名患者需要额外的手术,17%的人报告说哮喘完全不受控制,与12个月时的0%相比(p<0.01)。
结论:我们的实际结果证实了Dupilumab治疗严重和不受控制的CRSwNP的有效性。
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