Real life observational study of treatment success of monoclonal antibody treatment for refractory chronic rhinosinusitis with nasal polyps.

• Conditions: J30; Vasomotor and allergic rhinitis

• Registration Number: DRKS00031311
• Lead Sponsor: HNO Uniklinik

Brief Summary

Thirty-three patients were included in this study. Mean SNOT-22 score and NPS improved significantly. Subjective assessment of sense of smell showed an improvement in 81.8 % of patients. The monoclonal antibody had to be changed in 7 patients. No severe adverse events occurred during initiation of treatment and follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Study Completion: 2023-06-01
• Results First Posted: 2023-06-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Age = 18 years at therapy initiation
- Diagnosis of severe therapy-resistant chronic rhinosinusitis with nasal polyposis and indication for therapy with one of the approved biologics at the ENT University Hospital Freiburg in the analysis period 2019 to 2022.
- Consent to data collection

Exclusion Criteria

Age < 18 years at initiation of therapy
- Lack of indication for biologic therapy
- Lack of consent to data collection

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Change in SNOT-22 quality of life as difference from baseline before biologic therapy 1 year after therapy initiation.<br>- Change in nasal polyp score as difference from baseline before biologic therapy 1 year after initiation of therapy

Secondary Outcome Measures

Name	Time	Method
Change in SNOT-22 quality of life as difference from baseline before biologic therapy 4 weeks, 3 months and 6 months after therapy initiation.<br>- Change in nasal polyp score as a difference from baseline before biologic therapy 4 weeks, 3 months and 6 months after initiation of therapy<br>- Change in ability to smell<br>- Adverse events during therapy<br>- Number of sinus surgeries during ongoing biologic therapy<br>- Change of biologic due to non-response or complications<br>- Number of previous surgeries<br>- Demographic data (age, gender)<br>- Comorbidities (bronchial asthma, ASA intolerance)