METHODS: Since October 2019, we have investigated 40 patients (18 men, 22 women) treated with dupilumab in a single-center, retrospective single-arm longitudinal study. The following parameters were collected before treatment (baseline), at 1 month, 4 months, 7 months, 10 months, and 13 months: the Sino-Nasal Outcome Test-22 (SNOT-22), the forced expiratory pressure in 1 s (FEV-1), the olfactometry using Sniffin\' Sticks-12 identification test (SSIT), a visual analog scale of the total complaints, the Nasal Polyp Score (NPS), histologic findings as well as total serum IgE, eosinophilic cationic protein in serum and blood eosinophils.
RESULTS: The average age was 52.7 years (± 15.3). The follow-up period was 13 months. The SNOT-22 average was 60 points (± 22.2) at the first visit, 28.2 points (± 17.1) after 4 months and 20.8 points (± 17.7) after 13 months. The NPS was 4.3 points (± 1.5), after 4 months 2.1 points (± 1.3) and after 13 months 1.4 points (± 1.1). Olfactometry showed 3.2 points (± 3.7) at the baseline, 7.0 points (± 4.0) after 4 months and 7.8 points (± 3.5) after 13 months. The other parameters also improved. Most parameters showed linear dependence in the slopes under therapy (p < 0.001). Adverse side effects were mostly only mild, and no rescue therapy was needed.
CONCLUSIONS: There is a clear improvement in the medical condition and symptoms in all categories mentioned under therapy with dupilumab, as well as a reduction in the need for systemic glucocorticoids and revision surgery as rescue treatment. Our results show that dupilumab tends to be an effective therapy alternative for severe CRSwNP.
方法:自2019年10月以来,我们调查了40名患者(18名男性,22名女性)在单中心接受dupilumab治疗,回顾性单臂纵向研究。治疗前(基线)收集以下参数,在1个月,4个月,7个月,10个月,和13个月:Sino-Nasal结果测试-22(SNOT-22),1s内的用力呼气压力(FEV-1),使用Sniffin\'Sticks-12识别测试(SSIT)的嗅觉测定法,总投诉的视觉模拟量表,鼻息肉评分(NPS),组织学发现以及总血清IgE,血清和血液嗜酸性粒细胞中的嗜酸性阳离子蛋白。
结果:平均年龄为52.7岁(±15.3)。随访期为13个月。首次就诊时,SNOT-22的平均值为60分(±22.2),4个月后28.2分(±17.1),13个月后20.8分(±17.7)。NPS为4.3分(±1.5),4个月后2.1分(±1.3),13个月后1.4分(±1.1)。嗅觉显示基线时3.2点(±3.7),4个月后7.0分(±4.0),13个月后7.8分(±3.5)。其他参数也有所改善。大多数参数在治疗下显示斜率的线性依赖性(p<0.001)。副作用大多只是轻微的,不需要任何抢救治疗.
结论:在使用dupilumab治疗的所有类别中,医疗状况和症状均有明显改善,以及减少对全身性糖皮质激素和翻修手术作为抢救治疗的需求。我们的结果表明,dupilumab往往是严重CRSwNP的有效治疗替代方案。