针对复发性 CRSwNP,使用短疗程的双鲁单抗和 ESS 进行围手术期辅助治疗。

IF 7.2 2区 医学 Q1 OTORHINOLARYNGOLOGY International Forum of Allergy & Rhinology Pub Date : 2024-10-23 DOI:10.1002/alr.23471
Audrey Pelletier, Leandra Mfuna Endam, Emmanuel Gonzalez, Sheherazade Jannat, Thea Irani, Martin Desrosiers
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引用次数: 0

摘要

背景:慢性鼻窦炎伴鼻息肉病(CRSwNP)与内窥镜鼻窦手术(ESS)后的高复发率有关。2 型疾病的复发率较高,而且据信通过干扰上皮愈合和病原体免疫影响疾病的缓解。我们希望验证用抗IL4/IL13靶向单克隆抗体在围手术期控制2型炎症以及在术后缓解期控制2型炎症是否能更好地长期控制疾病:在这项前瞻性、安慰剂对照、双盲试验中。方法:在这项前瞻性安慰剂对照双盲试验中,30 名患有复发性 CRSwNP 的成年受试者接受了手术前 4 周(注射两针)开始的 ESS 加或减 14 周的围手术期杜比鲁单抗治疗。对鼻腔通畅度、嗅觉、生活质量(QoL)和不良反应等主观和客观参数进行监测,直至ESS后52周。对两种情况下的病原体定植情况进行了微生物培养:结果:ESS 安全地改善了两组患者鼻腔通畅度、嗅觉和生活质量的主观和客观指标。dupilumab治疗组的嗅觉保持时间更长,在ESS治疗后12个月,dupilumab治疗组33.3%的受试者出现嗅觉缺失,而安慰剂治疗组为50.0%。这与血清 IgE 的持续下降有关,而安慰剂治疗则没有出现这种情况。未发现异常安全信号:结论:使用杜匹单抗进行短程围手术期辅助治疗可改善长期嗅觉疗效并持续降低血清 IgE。
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Perioperative adjuvant therapy with short course of dupilumab with ESS for recurrent CRSwNP.

Background: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is associated with a high rate of disease recurrence following endoscopic sinus surgery (ESS). Type 2 disease is associated with a higher incidence of recurrence and is believed to impact disease resolution via interference with epithelial healing and pathogen immunity. We wished to verify if perioperative control of Type 2 inflammation with an anti-IL4/IL13 targeting monoclonal antibody and during the resolution period following surgery leads to better control of the disease long term.

Methods: In this prospective, placebo-controlled, double-blinded trial. Thirty adult subjects with recurrent CRSwNP underwent ESS plus or minus 14 weeks of perioperative dupilumab, initiated 4 weeks (two injections) pre-ESS. Subjective and objective parameters of nasal patency, olfaction, quality of life (QoL), and adverse events were monitored up to 52 weeks post-ESS. Microbiological culture was performed to characterize pathogens colonization under both conditions.

Results: ESS safely improved subjective and objective measures of nasal patency, olfaction, and QoL in both groups. Olfaction was conserved longer in the dupilumab-treated group, with 33.3% of subjects presenting anosmia at 12 months after ESS in the dupilumab group compared to 50.0% with placebo. This was associated with persistent decreases in serum IgE, which were not seen with placebo treatment. No unusual safety signals were observed.

Conclusion: Short-course adjuvant perioperative treatment with dupilumab is associated with improved long-term olfactory outcomes and persistent lowering of serum IgE.

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来源期刊
CiteScore
11.70
自引率
10.90%
发文量
185
审稿时长
6-12 weeks
期刊介绍: International Forum of Allergy & Rhinologyis a peer-reviewed scientific journal, and the Official Journal of the American Rhinologic Society and the American Academy of Otolaryngic Allergy. International Forum of Allergy Rhinology provides a forum for clinical researchers, basic scientists, clinicians, and others to publish original research and explore controversies in the medical and surgical treatment of patients with otolaryngic allergy, rhinologic, and skull base conditions. The application of current research to the management of otolaryngic allergy, rhinologic, and skull base diseases and the need for further investigation will be highlighted.
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