背景:Dupilumab的最新批准彻底改变了严重和顽固性慢性鼻鼻窦炎伴鼻息肉(CRSwNP)患者的管理。然而,目前仍缺乏一篇综述,该综述总结了现实生活中的研究结果,并将其与3期研究SINUS-24和52进行了比较.
方法:对2019年至2023年发表的所有现实生活中的研究进行了搜索。提取患者基线和开始Dupilumab后6个月和12个月的特征,并与3期试验的特征进行比较:年龄,性别,吸烟习惯,哮喘和阿司匹林加重的呼吸系统疾病(AERD),以前的内窥镜鼻窦手术(ESS),血嗜酸性粒细胞和总IgE,NasalAQ2息肉评分(NPS),气味,SNOT-22,不良事件(AE),以及对治疗的反应。
结果:共纳入15篇论文,患者总数为1658例。在现实生活研究中发现的患者中,合并症和先前的ESS发生率更高。此外,与来自SINUS-24和52的患者相比,他们在基线时的气味和SNOT-22更差.合并症和ESS后患者倾向于有更快的NPS和SNOT-22改善,虽然绝对值与临床无关.更广泛的手术和多个ESS≥2与更差的嗅觉结果相关,可能是医源性损伤造成的.血嗜酸性粒细胞与预后无相关性。12.4%的患者报告了AE,2.2%的患者不得不停止dupilumab。体重增加是紧急AE(0.8%),可能与恢复的嗅觉和味觉有关。无反应者为3.5%,他们被转换为全身性类固醇,ESS,或另一种生物。
结论:尽管各国之间的处方标准存在一些差异,dupilumab被证明即使在现实生活中也是有效的.然而,应考虑新出现的AE和可能的终身治疗的未知长期AE.
BACKGROUND: The recent approval of Dupilumab has profoundly revolutionized the management of patients affected by severe and recalcitrant Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). However, a review that summarizes the results of real-life studies and compares them to phase 3 studies SINUS-24 and 52 is still lacking.
METHODS: A search of all real-life studies published from 2019 to 2023 was performed. Patients characteristics at baseline and 6 and 12 months after starting Dupilumab were extracted and compared to those from phase 3 trials: age, sex, smoking habits, comorbid asthma and aspirin-exacerbated respiratory disease (AERD), previous endoscopic sinus surgery (ESS), hematic eosinophils and total IgE, NasalAQ2 Polyps Score (NPS), smell, SNOT-22, adverse events (AEs), and response to treatment.
RESULTS: 15 papers were included with an overall number of 1658 patients. A higher rate of comorbidities and previous ESS was found in patients from real-life studies. In addition, they had worse smell and SNOT-22 at baseline compared to patients from SINUS-24 and 52. Comorbid and post-ESS patients tended to have a faster NPS and SNOT-22 improvement, although the absolute values were not clinically relevant. A more extensive surgery and a number of ESS ≥ 2 were related to worse olfactory outcomes, probably due to iatrogenic damage. No correlation was found between hematic eosinophils and outcomes. AEs were reported by 12.4% of patients and 2.2% had to discontinue dupilumab. Weight gain was an emergent AE (0.8%), probably related to the restored sense of smell and taste. Non-responders were 3.5% and they were switched to systemic steroid, ESS, or another biologic.
CONCLUSIONS: Despite some differences in prescription criteria between countries, dupilumab was demonstrated to be effective even in the real-life scenario. However, emerging AEs and possible unknown long-term AEs of a likely lifelong therapy should be considered.