De Corso Eugenio, Montuori Claudio, De Maio Gabriele, D'Auria Leandro Maria, Rizzuti Alberta, Pacilli Maria Clara, D'Agostino Giuseppe, Mastrapasqua Rodolfo, Mele Dario Antonio, Galli Jacopo
Otorhinolaryngology Unit, A. Gemelli University Hospital Foundation IRCCS, Rome, Italy.
Department of Head-Neck and Sensory Organs, Catholic University of Sacred Heart, Rome, Italy.
Laryngoscope. 2025 Jul;135(7):2267-2274. doi: 10.1002/lary.32162. Epub 2025 Mar 28.
The aim of this study was to evaluate if dupilumab interval dose de-escalation to every 4 weeks negatively impacts treatment outcomes in real-life practice for severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) during the first 2 years of treatment.
We enrolled 148 patients who completed 2 years of follow-up. We compared two homogenous groups in terms of severity: group A included 77 patients who never modified the interval of administration during follow-up; group B included 71 patients who extended the dosing interval to monthly administration. We compared the treatment outcomes and differences in safety.
The monthly interval dose prolongation was started in 22/71 patients (30.99%) at 6 months, in 11/71 (15.48%) at 9 months, in 22/71 (30.99%) at 12 months, and in 16/71 (22.54%) at 18 months. The dose prolongation was to manage minor adverse events in 9 of 71 patients; persistent eosinophilia in 26/71 patients; specific request of patients who had confirmed sustained control as determined by the physician's assessment in 36/71 cases. Mean values of all outcomes of response to treatment (i.e., volume of polyps, nasal obstruction, quality of life, olfaction) significantly improved at 6, 12, and 24 months compared to baseline (p < 0.01) in both groups A and B. No significant differences were found comparing groups A and B for any of the outcomes examined over the 2 years of follow-up (p < 0.01).
These results suggest that extending to monthly dosing of dupilumab in real life does not negatively impact outcomes in patients with severe uncontrolled CRSwNP.
本研究旨在评估度普利尤单抗给药间隔延长至每4周一次是否会在治疗的前2年对严重未控制的伴鼻息肉慢性鼻-鼻窦炎（CRSwNP）患者的实际治疗效果产生负面影响。
我们纳入了148例完成2年随访的患者。我们根据病情严重程度比较了两个同质组：A组包括77例在随访期间从未改变给药间隔的患者；B组包括71例将给药间隔延长至每月一次的患者。我们比较了治疗效果和安全性差异。
71例患者中，22例（30.99%）在6个月时开始延长给药间隔至每月一次，11例（15.48%）在9个月时开始，22例（30.99%）在12个月时开始，16例（22.54%）在18个月时开始。延长给药间隔的原因包括：71例患者中有9例是为了处理轻微不良事件；26例是因为持续性嗜酸性粒细胞增多；36例是根据医生评估确认病情已持续得到控制的患者提出的特殊要求。与基线相比，A组和B组在治疗6个月、12个月和24个月时，所有治疗反应结果（即息肉体积、鼻塞、生活质量、嗅觉）的平均值均有显著改善（p<0.01）。在2年的随访期间，A组和B组在任何一项观察结果上均未发现显著差异（p<0.01）。
这些结果表明，在现实生活中将度普利尤单抗的给药间隔延长至每月一次，对严重未控制的CRSwNP患者的治疗效果没有负面影响。
