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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
)

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)

Komatsubara Masaki

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Mizuno Atsuhiro

PPD-SNBL

St Luke's Tower 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo, Japan

+81-80-9240-8673

atsuhiro.mizuno@thermofisher.com

Pending

May. 27, 2025

Observational

To participate in this study patients must meet all of the following inclusion criteria at index
date:
1. >-18 years of age at initiation of mepolizumab
2. 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.
3. Mepolizumab initiation is defined as:
Physician's decision to prescribe mepolizumab for treatment of CRSwNP; patient
treatment-naive at time of study enrolment.
4. Patients must be willing and able to provide voluntary informed consent.
5. 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:
1. 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)
2. Prior participation in an interventional study that includes treatment with mepolizumab.
3. 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.
4. Prior use of another respiratory biologic (including but not limited to omalizumab, dupilumab, tezepelumab, or benralizumab) within six months of mepolizumab index date.
5. Use of concomitant therapy with another respiratory biologic at the time of mepolizumab treatment.
6. 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.
7. 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).

Both

Chronic Rhinosinusitis with Nasal Polyps

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

1. To evaluate the mean change in the SNOT-22 total score from baseline to months 3 and 6 whilst being treated with mepolizumab in Japan.
2. To evaluate the mean change in the rhinosinusitis Visual Analogue Scale (VAS) for smell dysfunction and nasal obstruction from baseline to months 3, 6, and 12 whilst being treated with mepolizumab in Japan.
3. To describe the occurrence of CRSwNP related exacerbations at months 3, 6, and 12 whilst being treated with mepolizumab in Japan.
4. To describe the NP score before mepolizumab treatment and at month 12 whilst being treated with mepolizumab in Japan.
5. To describe the proportion of patients undergoing NP related surgery at months 3, 6, and 12 whilst being treated with mepolizumab in Japan.
6. To evaluate the reduction in overall OCS dose utilisation from baseline to months 3, 6, and 12 whilst being treated with mepolizumab in Japan.
7. To describe the rate of CRSwNP related healthcare resource utilization (HCRU) in the 12 months prior to mepolizumab initiation with post-mepolizumab treatment values at 12 months whilst being treated with mepolizumab in Japan.
8. To evaluate the mean change in Work Productivity and Activity Impairment-General Health (WPAI-GH) from baseline to months 3, 6, and 12 whilst being treated with mepolizumab in Japan.
9. To describe mepolizumab treatment patterns including dose modification/interruptions, treatment cessation, and changes in concomitant mediations over the follow-up period whilst being treated with mepolizumab in Japan.

+81-3-6416-1868

April. 10, 2025

No

none