Rhinology Unit, Department of Otolaryngology, University Hospital Virgen Macarena, Seville, Spain.
Biomedical Engineering Group, University of Seville, Seville, Spain.
Curr Allergy Asthma Rep. 2023 Oct;23(10):555-566. doi: 10.1007/s11882-023-01106-w. Epub 2023 Aug 30.
Despite molecular underlying advances, limited and divergent data on monoclonal antibodies (mAb) therapy in chronic rhinosinusitis with nasal polyps (CRSwNP) make further analysis necessary. The objective of this study is to evaluate the effect of omalizumab as an adjunct to endoscopic sinus surgery (ESS) on the treatment of CRSwNP under real-life conditions.
Since the introduction of omalizumab, as the first biologic agent for the treatment of diseases such as severe allergic asthma, different studies have demonstrated an effect of omalizumab on CRSwNP, with significant improvements in sinonasal symptoms and endoscopic scores. The high efficacy derived from mAb therapy and the need for ESS prior to mAb recommended by guidelines, has led to compare both therapeutic alternatives, finding discrepancies in their effect on quality of life (QoL) and complementary tests outcomes. Patients with moderate-to-severe asthma with clinical criteria for omalizumab indication, and coexistent CRSwNP disease, were selected for a non-randomized interventional retrospective study into four treatment subgroups. Measures were analyzed and compared between groups and over time at the baseline, 16 weeks and 1 and 2 years after treatment. Omalizumab treatment in patients with previous ESS exhibited an earlier and more pronounced improvement in QoL, symptoms scale and endoscopic findings (nasal polyp score and the bilateral modified Lund-Kennedy) as early from week 16, which improvement persisted for 2 years. A greater mean improvement of 33.4 ± 6.5 (95% CI: 20.3-46.4; p < 0.001) points in sinonasal outcome test 22 (SNOT-22) was associated with ESS at week 16, against omalizumab effect (17.8 ± 7.6 [95% CI: 2.6-33.0]; p = 0.023). At year 2, an improvement in SNOT-22 of 62.6 ± 8.9 (95% CI: 48.4-84.1; p < 0.001) points was exclusively associated with omalizumab. Clinical evidence of the effect of omalizumab added to ESS treatment is provided in this study in the short- and long-term.
尽管在分子基础研究方面取得了进展，但慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）患者的单克隆抗体（mAb）治疗数据有限且存在差异，因此有必要进行进一步分析。本研究旨在评估奥马珠单抗作为内镜鼻窦手术（ESS）辅助治疗在真实环境下对 CRSwNP 的疗效。
自奥马珠单抗问世以来，作为治疗重度过敏性哮喘等疾病的首个生物制剂，不同的研究表明奥马珠单抗对 CRSwNP 有效，可显著改善鼻-鼻窦症状和内镜评分。mAb 治疗的高疗效以及指南推荐在使用 mAb 之前需要 ESS，这促使我们比较了这两种治疗选择，发现它们对生活质量（QoL）和补充检查结果的影响存在差异。从中度至重度哮喘患者中筛选出符合奥马珠单抗适应证的临床标准且合并 CRSwNP 疾病的患者，进行一项非随机干预性回顾性研究，将其分为四个治疗亚组。在基线、治疗后 16 周、1 年和 2 年时对各项指标进行分析和比较。既往接受 ESS 治疗的患者的 QoL、症状量表和内镜检查结果（鼻息肉评分和双侧改良 Lund-Kennedy）更早（从第 16 周开始）且改善更明显，2 年内这种改善持续存在。在第 16 周时，SNOT-22 评分的平均改善程度为 33.4±6.5（95%CI：20.3-46.4；p<0.001），与 ESS 相关，而奥马珠单抗的疗效为 17.8±7.6（95%CI：2.6-33.0；p=0.023）。在第 2 年时，SNOT-22 评分的改善程度为 62.6±8.9（95%CI：48.4-84.1；p<0.001），仅与奥马珠单抗相关。本研究提供了奥马珠单抗联合 ESS 短期和长期治疗效果的临床证据。
