J REALITI-N: An Observational Study to Evaluate the Real-World Effectiveness of Mepolizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Japan (J REALITI-N )

GlaxoSmithKline K.K.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2025年5月27日

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•To participate in this study patients must meet all of the following inclusion criteria at index
•>-18 years of age at initiation of mepolizumab
•Patients with an investigator's main diagnosis of CRSwNP confirmed by clinical
•criteria (including any imaging if performed) where CRSwNP is the main diagnosis
•indicated for use of mepolizumab per Japanese labelling requirements.
•Mepolizumab initiation is defined as:
•Physician's decision to prescribe mepolizumab for treatment of CRSwNP; patient
•treatment-naive at time of study enrolment.
•Patients must be willing and able to provide voluntary informed consent.
•Patients must be able to understand and complete study-related questionnaires.
•Patients must have access to a compatible device and internet access for electronic
•patient-reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection.

•Patients who meet any of the following criteria at the index date are not eligible to participate in this study:
•Participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP at the same time as the index date (mepolizumab initiation)
•Prior participation in an interventional study that includes treatment with mepolizumab.
•Diagnosis of eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, cystic fibrosis, immunodeficiency, and primary ciliary dyskinesia, or any other condition that would make it difficult for the participant to fulfil the study criteria, per the investigator's discretion.
•Prior use of another respiratory biologic (including but not limited to omalizumab, dupilumab, tezepelumab, or benralizumab) within six months of mepolizumab index date.
•Use of concomitant therapy with another respiratory biologic at the time of mepolizumab treatment.
•Three or more functional endoscopic sinus surgery (FESS), which includes anterior maxillectomy and/or ethmoidectomy and/or sphenoidotomy, or three or more ESS with or without DRAF IIb or DRAF III.
•Pregnant or breastfeeding at the mepolizumab initiation (note: patients who become pregnant during the study will not be excluded, provided they consent to continue with mepolizumab).

To evaluate the mean change in the SNOT-22 total score from baseline to 12 months whilst being treated with mepolizumab in Japan.

SNOT-22 total score(months 3 and 6)
rhinosinusitis Visual Analogue Scale (VAS) for smell dysfunction and nasal obstruction(months 3, 6, and 12)
CRSwNP related exacerbations(months 3, 6, and 12)
NP score(before mepolizumab treatment and month 12)
proportion of patients undergoing NP related surgery(months 3, 6, and 12)
overall OCS dose utilisation(months 3, 6, and 12)
CRSwNP related healthcare resource utilization (HCRU)(12 months prior to mepolizumab initiation and 12 months post-mepolizumab treatment)
Work Productivity and Activity Impairment-General Health (WPAI-GH)(months 3, 6, and 12)
mepolizumab treatment patterns(over the follow-up period)

发起方

GlaxoSmithKline K.K.