Department of Otolaryngology-Head and Neck Surgery, European Institute of Oncology, Milan, Italy.
Department of Otorhinolaryngology, University of Insubria and ASST Sette Laghi, Varese, Italy.
Acta Otorhinolaryngol Ital. 2020 Dec;40(6):435-443. doi: 10.14639/0392-100X-N0716.
The introduction of monoclonal antibody (mAb) therapies represents a promising treatment for refractory chronic rhinosinusitis (CRS). We assessed the effects of selected mAbs (omalizumab, mepolizumab, benralizumab) on CRS in severe asthmatic patients in a real-life setting.
A prospective observational study on severe asthmatic patients, treated with 3 different mAb (omalizumab, mepolizumab, benralizumab), and comorbid CRS was conducted. All patients were followed for 52 weeks. The degree of nasal control, SinoNasal Outcome Test (SNOT) 22, Nasal Polyp Score (NPS), Lund Kennedy Score (LKS) were collected at baseline and at 52-week.
40 patients (33 with nasal polyps) were studied. 33 patients (82.5%) had uncontrolled nasal disease at baseline, and 15 (37.5%) were uncontrolled after 52 weeks. Significant improvement was observed for SNOT 22 (P < 0.001), SNOT 1-12 (P < 0.001) and degree of nasal control (P < 0.001). Differences in NPS (P = 0.130) and LKS (P = 0.124) were not significant. Net change in the above-mentioned parameters among the three treatment groups was not significantly different.
The study shows an improvement of nasal symptoms after 52 weeks of mAb treatment, which was not associated with significant improvement of endoscopic findings. Larger studies are needed to assess the real-life efficacy of mAbs in CRS.
单克隆抗体（mAb）疗法的引入代表了一种有前途的难治性慢性鼻-鼻窦炎（CRS）治疗方法。我们评估了在现实环境中，在严重哮喘患者中使用选定的 mAb（奥马珠单抗、美泊利单抗、贝那利珠单抗）治疗 CRS 的效果。
对接受 3 种不同 mAb（奥马珠单抗、美泊利单抗、贝那利珠单抗）治疗且伴有 CRS 的严重哮喘患者进行了前瞻性观察研究。所有患者均随访 52 周。在基线和 52 周时收集了鼻腔控制程度、SinoNasal Outcome Test（SNOT）22、鼻息肉评分（NPS）、Lund Kennedy 评分（LKS）。
共纳入 40 例患者（33 例有鼻息肉）。33 例（82.5%）患者在基线时鼻腔疾病未得到控制，15 例（37.5%）患者在 52 周后仍未得到控制。SNOT 22（P < 0.001）、SNOT 1-12（P < 0.001）和鼻腔控制程度（P < 0.001）均显著改善。NPS（P = 0.130）和 LKS（P = 0.124）的差异无统计学意义。三个治疗组之间上述参数的净变化无显著差异。
本研究表明，在接受 mAb 治疗 52 周后，鼻腔症状得到改善，但与内镜检查结果的显著改善无关。需要更大规模的研究来评估 mAb 在 CRS 中的实际疗效。
