Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Nasal congestion is scored from 0 ("No symptoms") to 3 ("Severe symptoms"). Higher scores denote greater symptom severity.

Changes from baseline in NCS will be measured at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab).

The total nasal polyp score (NPS) is an endoscopic nasal polyp scoring system to quantify nasal polyps with endoscopy. The higher the score, the more polyps are present in the nose. A unilateral score from 0 (absence of polyps) to 4 is given. The total nasal polyp score is the sum of the scores for both nostrils, thus ranging from 0 to 8, and is based on the continuous extension of nasal polyps beyond clear landmarks such as the upper and lower borders of the middle and inferior turbinate. This implies that a score can only be attributed if the criteria of the lower scores are met. E.g. a unilateral score of 3 cannot be given without nasal polyps also meeting the criteria for a score of 2, and similarly, a score of 4 cannot be given without having a score of 3.

Changes from baseline in NPS will be measured at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological.

The rhinosinusitis severity VAS is used to evaluate the overall severity of the rhinosinusitis. It is a recommended scale to determine the patient's disease severity and to guide the treatment for CRS. The participant is asked to answer the following question: "How troublesome are your symptoms of your rhinosinusitis" on a 10-cm VAS from 0 ('not troublesome') to 10 ('worst thinkable troublesome'). Based on their score on the VAS, the severity of rhinosinusitis can be divided into 3 categories as follows:

• Mild = VAS 0 to 3
• Moderate = VAS >3 to 7
• Severe = VAS >7 to 10

In this study, changes from baseline in VAS-scores at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab) will be measured.

The SNOT-22 is a questionnaire designed to assess the impact of chronic rhinosinusitis on the patients' QoL. It has 22 items covering symptoms, social/emotional impact, productivity, and sleep consequences of CRS. Each item is rated on a 6-point Likert scale response option, ranging from 0 ('No problem') to 5 ('Problem as bad as it can be'). A global score ranging from 0 to 110 is calculated by summing the responses to all items; higher score indicates greater rhinosinusitis-related health burden.

This study investigates changes from baseline in SNOT-22 at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab).

The ACQ-5 was designed to measure both the adequacy of asthma control and change in asthma control. The participants are asked to recall how their asthma has been during the previous week and to respond to 5 questions on a 7-point scale (0 = no impairment, 6 = maximum impairment).

A global score is calculated as follows: the questions are equally weighted, and the ACQ-5 score is the mean of the 5 questions and, therefore, falls between 0 (totally controlled) and 6 (severely uncontrolled). A higher score indicates lower asthma control.

This study evaluates changes from baseline in ACQ-5 at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab).

The AQLQ is comprised of 32 items, each rated on a 7-point Likert scale from 1 to 7. A higher score indicates better quality of life.

This study evaluates changes from baseline in AQLQ at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab).

sQOD-NS patient-reported outcome questionnaire includes social, eating, annoyance, and anxiety questions. Items are rated on a scale of 0-3, with higher scores reflecting the better olfactory-specific quality of life (QOL). The total score ranges from 0 (severe impact on QoL) to 21 (no impact on QoL).

This study evaluates changes from baseline in sQOD-NS at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab).

Patients are asked at every consultation whether they took their biological treatment correctly according to the treatment schedule or if a problem occurred ( missed injection, problem with the injection,..)

Baseline characteristics (such age, gender, presence of comorbidities,...) of non-responders will be analyzed to evaluate if any of them can correlate to a response of a biological.