Biologikatherapie bei Patienten mit Chronischer Rhinosinusitis mit Nasenpolypen – gezielte Therapie bei Typ-II-Inflammation

Chronic rhinosinusitis with nasal polyps (CRScNP) is a common pathology with inflammation of the mucosa of the main nasal cavities and sinuses, which can severely limit the quality of life of affected patients. Recently the focus in diagnostics and therapy of CRScNP has been increasingly directed towards type II inflammation. With the biologics dupilumab, omalizumab and mepolizumab, first therapy options have been approved in Germany that specifically target type II inflammation. The present study aimed to investigate the changes in quality of life, polyp size and olfactory performance of the first patients who received biologic therapy in the Department of Rhinology and Allergology of the University Hospital Marburg under real-life conditions. For this purpose, data from 52 patients who presented for biologic therapy between May 2020 and April 2022 with a diagnosis of CRScNP were retrospectively examined. 28 patients were treated with dupilumab, 18 patients with omalizumab and 6 patients with mepolizumab. The results of the NPS, SNOT-22 questionnaires and Sniffin' Sticks test were collected and statistically analysed in Excel and with the R analysis tool. These results were then compared between the biologics and with the pivotal studies. The evaluation showed an average age of 52 years, which fits the description of CRScNP as a disease of middle age. Likewise, the gender ratio of men to women of 65.4% to 34.6% in our collective was consistent with the higher prevalence of CRScNP in men. On average patients had 2.8 previous surgeries, with a maximum of 8. 28.8% of patients underwent only one previous surgery, 40% more than 2. Thus, our collective showed a higher percentage of patients with more than 2 previous surgeries compared to the pivotal studies. With 75% and 44.2% of patients presenting with bronchial asthma and AERD respectively, the prevalence of these secondary diagnoses is higher than in the collectives of the pivotal studies, which can be explained by the outpatient clinic's specialisation in patients with this condition. The therapy was generally very well tolerated, with only occasional reports of mild side effects, which led to the suspension of therapy in only one case. In our patient collective, all groups showed a significant improvement in the NPS, the SNOT-22 and the SDI. This indicates a significant reduction in polyp size, subjective burden of disease and an improvement in the sense of smell during therapy. In our collective improvement already becomes apparent after a very short duration of therapy and is sustained during the course or even ongoing. This is comparable to the improvements in the pivotal studies. Thus, in our patients, under real-life conditions, the expectations of biologic therapy raised by the pivotal studies are met. There is a clear improvement in NPS, SNOT-22 and SDI under ongoing therapy, even without surgery. The patients with the secondary diagnoses AERD and asthma benefited just as well from the biologic therapy as the patients without these secondary diagnoses. There was no statistically significant difference between the effects of the therapy with dupilumab or omalizumab in our collective. In the dupilumab group, there was a positive correlation between female gender and improvement in SDI. This suggests that dupilumab leads to a stronger improvement in olfaction in women than in men. No relevant correlations could be shown between age, previous surgery, secondary diagnoses or laboratory findings related to baseline values and changes in NPS, SNOT-22 or SDI scores. In our collective, by the end of data collection, insufficient improvement of symptoms was observed in 10 of 52 patients. In these patients, the therapy was either complemented by surgery or oral glucocorticoid therapy or the biologic was exchanged with another substance after consultation with the physician and at the patient's request. This is lower than the non-responder rate from literature, which is 25-50%, depending on the respective substance. The results of this study show the strong therapeutic effect of biologics in the treatment of severe CRScNP. Although the significance of our data is limited due to the small number of patients, our results show clear agreement with the data from other German real-world-effectiveness studies. In future studies, the question of which substance to choose for which patient should be investigated by a prospective 'head-to-head' comparison between the biologics. For this purpose, biomarkers should also be identified that could predict the response to the therapy to better select suitable patients for the appropriate form of therapy in the future.