Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps

Regulatory Post-Marketing Surveillance (rPMS) of Xolair® (Xolair® 150mg Powder for Solution for Injection, Xolair® 150mg/1ml Liquid in Pre-filled Syringe, Xolair® 75mg/0.5ml Liquid in Pre-filled Syringe) for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.

This is a 24-week, prospective, open-label, multi-center, single-arm, observational, post-marketing surveillance study under routine clinical practice and does not impose a therapy, visit, or assessment. The study design was approved by the Korean health authority. The purpose of this study is not to answer scientific hypotheses, but to describe the incidences of all potential adverse events (AEs), serious adverse events (SAEs), and unexpected AEs not listed in the local label information occurring in Korean patients under routine clinical practice following the approved local label information.

Inclusion Criteria:

1. Adults aged ≥18 years
2. Patients with CRSwNP who are not adequately controlled with conventional therapy (INCS)
3. Patients prescribed with Xolair® as per the locally approved label information.
4. Patients who provide written informed consent to participate in the study

Exclusion Criteria:

1. Patients who do not provide consent to participate in the study

2. Patients participating in other clinical trial

3. Contraindications listed in the locally approved label information of Xolair®

   • Hypersensitivity to the active ingredient or any other ingredient of Xolair®
   • Patients with myocardial infarction or history of myocardial infarction (pre-filled syringes only)